Foot orthoses in the Management of Anterior Knee Pain: An Evidence Informed Pragmatic Clinical Approach.
Prof Bill Vicenzino Title: Foot Orthoses in the Management of Anterior Knee Pain: An Evidence Informed Pragmatic Clinical Approach
Presenter’s Details: Bill Vicenzino PhD, MSc, BPhty, Grad Dip Sport Phty Professor (Sports Physiotherapy) & Head of Physiotherapy, University of Queensland Email: [email protected]
Overview synopsis: If you see clients who have overuse injuries such as patellofemoral pain and you are not too confident about the examination of the foot, its role in these conditions and prescribing foot orthoses, then this course is for you. It provides a simple yet effective means of understanding foot function and its role in the treatment of lower limb overuse injuries. More importantly it teaches Vicenzino’s new and efficient way to make a clinical decision on the appropriateness of orthoses in treating overuse injuries. Orthotic prescription is demonstrated and practised. Importantly, integrating the use of foot orthoses with exercises, manual therapy and other physical therapy management (i.e., integration into an overall physical therapy management plan) is covered during the 2-day workshop. Bill is a Prof in Sports Physiotherapy at the University of Queensland (Australia) and leads a productive research team that has a track record in this area with numerous publications and competitive research grants underpinning the workshops and presentations.
Aims and Objectives: After the course, participants will be able to: a) Outline the evidence underpinning the use of foot orthoses in the management of anterior knee pain (largely patellofemoral pain) and its role in the decision making process in the physiotherapy treatment plan. b) Evaluate foot structure and function to identify movement impairments and be able to relate this to the pathomechanics of overuse injuries generally, and patellofemoral pain specifically. c) Understand the traditional mechanical method of decision-making in selecting foot orthoses and its limitations. d) Implement a new method of clinical reasoning in the selection of foot orthoses, namely the Treatment Direction Test. e) Select and fit an orthoses appropriate to the needs of the client. f) Measure the effectiveness of foot orthosis therapy intervention in patellofemoral pain. g) Understand orthosis therapy in the broader physiotherapy context in describe how foot orthoses integrate into physical therapy management.
Preliminary program (subject to alteration): Session Time (hr) Topic Handout Part 1 2 Foot orthoses in patellofemoral pain: evidence based considerations A, H-J 2 2 Background overview of ankle and foot structure and function/dysfunction: gait B 3 1.5 Orthoses, overuse injuries (PFP) and the treatment direction test (TDT) C, G 4 1.5 Orthoses selection reasoning, TDT and fitting lecture D 4-5 4 Orthoses fitting and TDT practical D 6 2 Integrating orthoses within the physical therapy treatment plan E, G 7 1.5 Foot and ankle assessment and treatment practical F 8 1.5 Discussion, Q&A and wrap up Vicenzino B. Foot orthotics in the treatment of lower limb conditions: a musculoskeletal physiotherapy G perspective. Manual Therapy 9 (2004) 185-96
Collins N, Bisset L, McPoil T, Vicenzino B. (2007) Foot orthoses in lower limb overuse conditions: A H systematic review and meta-analysis. Foot & Ankle International, 28(3): 396-412.
Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T. Foot orthoses and physiotherapy in I the treatment of patellofemoral pain syndrome: A RCT. BMC Musculoskeletal Disorders 2008, 9:27 doi:10.1186/1471-2474-9-27
Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in J the treatment of patellofemoral pain syndrome: RCT. BMJ BMJ 2008;337;a1735 doi:10.1136/bmj.a1735
PART A:
Foot orthoses in patellofemoral pain: evidence based considerations Vicenzino et al (2008), Protocol Paper. BMC Musculoskelet Disord, 9:27 http://www.biomedcentral.com/1471-2474/9/27
Inclusion criteria: 1. Non-traumatic AKP >6weeks, provoked by 2 of following: • Prolonged sitting or kneeling • Squatting • Jogging or running • Hopping or Jumping • Stair walking 2. Pain on palpation of peripatellar tissues, or pain on step down (25cm step) or double leg squat 3. Pain over previous week ≥30mm / 100mm VAS 4. Between 18-40 years of age
Vicenzino et al (2008), Protocol Paper. BMC Musculoskelet Disord, 9:27 http://www.biomedcentral.com/1471-2474/9/27
Exclusion criteria: 1. Other knee injury or pathology: current or past 2. Positive patellar apprehension test 3. Knee joint effusion 4. Foot condition not suitable for orthoses 5. Pain in or referred from hip or lumbar spine 6. Previous treatment with foot orthoses
Idiopathic pain arising from the front of the knee Australian Acute Musculoskeletal Pain Guidelines Group (2003), Evidence based management of acute musculoskeletal pain , Brisbane: Australian Academic Press Pty. Ltd., 2003
Common condition; long term impact Witvrouw et al (2000), Am J Sports Med 2000, 28(4):480-9 Nimon et al (1994), J Pediatr Orthop, 18(1):118-22
Poor prognosis: longer duration & more severe pain Collins et al (2010) BMC Musculoskel. Disorders 2010;MS : 1661579623298564 Witvrouw et al (2002) Scandinavian J Med & Sci in Sports. 12(1):40-6.
1 Crossley K, Bennell K, Green S, McConnell J (2001) A systematic review of physical interventions for PFPS, Clinical J Sport Med 11(2): 103-10 • Of 89 potential candidates only 16 studies met the criteria of RCT • Physiotherapy evaluated in 8 trials and the remaining other physical interventions • Braces, PF orthoses, acupuncture, laser, chiropractic, and patellar taping had no evidence supporting them • Foot orthosis and progressive strengthening exercises were effective, but low quality RCT limiting generalizability
Eng JJ and Pierrynowski MR (1993) Evaluation of soft foot orthotics in the treatment of PFPS. Physical Therapy 73(2): 62-70 • 20 females (15(1)yr) with PFPS (10(10)mth duration) + excess pronation • Treatment group = exercise + orthotic • Control group = exercise (quads & hams) • 1 therapist session & 3 random calls for compliance! • 8 week follow up on pain VAS • Both improved on PVAS but orthotic superior • Inadequate data provided to derive point estmates of effect
Collins N, Bisset L, McPoil T, Vicenzino B. (2007) Foot orthoses in lower limb overuse conditions: A systematic review and meta- analysis. Foot & Ankle International, 28(3): 396-412.
22 RCTs identified: 15 were treatment studies 2 on PFPS/AKP Issues with studies of treatment with orthoses: Small participant numbers Few used adequate placebo controls Multitude of outcome measures used Usually poor methodological quality
2 Wiener-Ogilvie S and Jones RB (2004) A randomised trial of exercise therapy & foot orthoses as treatment for knee pain in primary care. Br J Pod 7:43-9
Intervention Age N Duration
Pre-fabricted Orthoses` 39(17) 11 17.9(17.8)
Exercise 51(23) 10 10.6(8.2)
Orthoses`X(SD) + Exercise 62(10) 11 29.8(38)
Main inclusion criteria: Antero-medial knee pain with pronation (ascertained on clinical exam)
Wiener-Ogilvie S and Jones RB (2004) A randomised trial of exercise therapy & foot orthoses as treatment for knee pain in primary care. Br J Pod 7:43-9
8 week follow up
Orthoses + Exercise (n9) -v- Exercise (n9): RR: 1.14 (0.75 to 1.74) pVAS SMD: 0.87* (-0.11 to 1.85) cm
Orthoses (n9) -v- Exercise (n9) : RR: 0.57 (0.25 to 1.28) pVAS : 0.8 (-0.17 to 1.77) cm
Eng JJ and Pierrynowski MR (1993) Evaluation of soft foot orthotics in the treatment of PFPS. Phys Ther 73: 62-70
• 20 females 14.8 ± 1.2 years PFP • Excessive pronation • nWB Forefoot varus >6° • WB Rearfoot valgus >6°
• Randomised to posted or non- posted soft orthosis (spenco) • All did home exercises general strengthening and stretching
• Outcome: gait, sit, squat at 2, 4, 6 & 8 weeks
3 • N = 20 females 14.8 ± 1.2 years • Excessive pronation
Eng & Pierrynowski (1993) Phys Ther, 73(2):62-8
Vicenzino, Collins, Crossley et al (2008), Protocol Paper. BMC Musculoskelet Disord, 9:27 http://www.biomedcentral.com/1471-2474/9/27
National Health and Medical Research Council of Australia: 1. Vicenzino: Primary Health Care Project Grant (#301037). 2. Collins: Public Health Scholarship (#351663)
RCT: questions
1. Are foot orthoses more effective than flat inserts?
2. Are foot orthoses more effective than physiotherapy?
3. Does adding foot orthoses to physiotherapy improve outcome?
4 RCT: methodology
179 participants with AKP (informed consent) Outcome measures (baseline)
Randomisation (concealed allocation)
Foot orthoses Flat inserts Physiotherapy Foot orthoses & Physiotherapy (n=46) (n=44) (n=45) (n=44)
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
RCT: interventions
1. Foot orthoses (Vasyli International)
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
RCT: interventions
2. Flat inserts
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
5 RCT: interventions
3. Physiotherapy Crossley et al (2002), Am J Sports Med, 30(6):857-65
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
RCT: interventions
4. Foot orthoses + Physiotherapy
+
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
RCT: methodology
179 participants with AKP (informed consent) Outcome measures (baseline) Randomisation (concealed allocation)
Foot orthoses Flat inserts Physiotherapy Foot orthoses & Physiotherapy (n=46) (n=44) (n=45) (n=44)
6 appointments with Physiotherapist over 6 weeks
Outcome measures: 6, 12, 52 weeks
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
6 RCT: outcome measures
Global improvement
Much worse Same Completely better
Marked improvement Moderate improvement Same Moderate worsening Marked worsening
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
RCT: outcome measures
Global improvement
Much worse Same Completely better
Marked improvement SUCCESS Moderate improvement Same Moderate worsening Non-success Marked worsening
Vicenzino, Collins, Crossley et al (2008), BMC Musculoskelet Disord, 9:27
RCT: participant characteristics (n=179)
Age 29.3 ± 5.8 years Gender 56% female BMI 24.8 ± 5.1 kg/m2
Bilateral AKP 57% bilateral
Duration of AKP 28 (12-84) months
Worst pain VAS 60.5 ± 15.9 mm
Anterior Knee Pain Scale 71.5 ± 9.8
Functional Index Questionnaire 9.8 ± 2.1
Collins et al (2008), BMJ 2008: 337:a1735
7 RCT results: global improvement
70
60
50
40 millimetres 30
20 Foot orthoses Flat inserts 10 Physiotherapy Physiotherapy & Foot orthoses
0 6 12 52 weeks weeks weeks Collins et al (2008), BMJ 2008: 337:a1735
RCT results: global improvement
70
60
50
40 millimetres 30 19.8 mm (4.0 to 35.6)* * RRR 0.66 (0.05 to 1.17)* 20 NNT 4 (2 to 51)* Foot orthoses Flat inserts 10
0 6 12 52 weeks weeks weeks Collins et al (2008), BMJ 2008: 337:a1735
An aside: global improvement
70
60 NNT 2 (1 to 4) orthoses v wait and see (Mills)
50
40 millimetres 30 19.8 mm (4.0 to 35.6)* * RRR 0.66 (0.05 to 1.17)* 20 NNT 4 (2 to 51)* Foot orthoses Flat inserts 10
0 6 12 52 weeks weeks weeks
8 RCT results: global improvement
70 2.4 (-20.0 to 24.8) RRR 0.42 (-0.43 to 1.24) 60 NNT 9
50
40 millimetres 30 16.1 (-3.0 to 35.3) RRR 0.1 (-0.99 to 1.2) 20 NNT 50 Foot orthoses Flat inserts 10
0 6 12 52 weeks weeks weeks Collins et al (2008), BMJ 2008: 337:a1735
RCT results: global improvement
70 6.7 (-12.1 to 25.5) 2.4 (-19.9 to 24.7)
60 RRR 0.1 (-1.06 to 1.25) RRR -0.22 (-1.6 to 1.14) NNT 51 NNT -29
50
40
millimetres 7.8 (-7.8 to 23.5) 30 RRR 0.5 (-0.84 to 1.85) NNT 14 20 Foot orthoses
10 Physiotherapy
0 6 12 52 weeks weeks weeks Collins et al (2008), BMJ 2008: 337:a1735
RCT results: global improvement 8.4 (-10.7 to 27.4) 70 0.5 (-22.0 to 23.0) RRR 0.71 (-0.44 to 1.87) NNT 8 RRR 0.02 (-1.13 to 1.18) 60 NNT 226
50
40 3.2 (-12.3 to 18.8) RRR -0.3 (-2.83 to 2.24)
millimetres NNT -45 30
20
10 Physiotherapy Physiotherapy & Foot orthoses 0 6 12 52 weeks weeks weeks Collins et al (2008), BMJ 2008: 337:a1735
9 RCT: questions
1. Are foot orthoses more effective than flat inserts? Foot orthoses are more effective than flat inserts in the short term (6 weeks)
2. Are foot orthoses more effective than physiotherapy? Foot orthoses and physiotherapy have similar short and long term effects
3. Does adding foot orthoses to physiotherapy improve outcome? No additional benefits of adding foot orthoses to physiotherapy
RCT: observations
Foot orthoses are more effective than flat inserts in the short term (6 weeks)
NNT 4 (99% CI 2 to 51)
Wide CI suggests heterogeneity of response if patients are treated randomly with foot orthoses Did not use any specific selection criteria for foot orthoses (e.g. foot posture, motion) … may underestimate the effect for some patients
Can we improve the success rate?
RCT results: global improvement
70 MD 15 (0.68 to 29.52) ; SMD 0.46 60 NNT 7; ARR -0.1405
50
40 millimetres 30 16.1 (-3.0 to 35.3) RRR 0.1 (-0.99 to 1.2) 20 NNT 50 (-5 to 4)
Foot orthoses & Physiotherapy 10 Foot orthoses Flat inserts
0 6 12 52 weeks weeks weeks Collins et al (2008), BMJ 2008: 337:a1735
10 Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B, Foot orthoses & physio in the treatment of PFPS: RCT BMJ 2008;337:a1735 doi=10.1136/bmj.a1735
Can we improve the success rate?
…by predicting who may benefit from an orthosis
Can we predict who will benefit?
Musculoskeletal Pain & Injury Research Unit Vicenzino B, Collins N, Cleland J, McPoil T. A clinical prediction rule for identifying patients with patellofemoral pain who are likely to benefit from foot orthoses: a preliminary determination. BJSM:
Published Online First: 26 September 2008. doi: 10.1136/bjsm.2008.052613.
17 Criteria for CPR to predict success @ 12 weeks: Foot width WB-NWB diff > 11mm (40%) Age >25 years Height < 165 cm Pain severity < 53 mm 25 3 2 1
17 12 53% 60% 6 85% 16 8 1
+LR (95% CI): 8.8 2.2 1.6 (1.2 to 66.9) (1.1 to 4.2) (1.2 to 2.1)
11 Plausibility of predictors (foot orthoses):
Foot posture and mobility measures:
Arch Width Difference
McPoil T, Vicenzino B, Cornwall M, Collins N, Warren M (2009) Reliability and normative values for the foot mobility magnitude: a composite measure of vertical and medial- lateral mobility of the midfoot. J Foot & Ankle Research , 2:6doi:10.1186/1757-1146-2-6
Plausibility of predictors: Mid-foot width difference from NWB to WB: • Plausible targets for ‘anti-pronation’ orthoses are: • increased foot mobility, and/or • lower arch • Foot measures found to be predictors by Sutlive et al (2004) …though the latter showed lower navicular drop and forefoot valgus to be predictors!
Arch Width Difference
Can we predict who will benefit?
Musculoskeletal Pain & Injury Research Unit Vicenzino B, Collins N, Cleland J, McPoil T. A clinical prediction rule for identifying patients with patellofemoral pain who are likely to benefit from foot orthoses: a preliminary determination. BJSM:
Published Online First: 26 September 2008. doi: 10.1136/bjsm.2008.052613.
12 Collins N, Beller E, Darnell R, McPoil T, Vicenzino B,, Foot orthotics in the treatment of AKP: A RCT in primary care. NHMRC project#301037
no stratification
for
‘biomechanical foot measures’
Sutlive et al Identification of individuals with PFP whose symptoms improved after a combined program of foot orthosis use and modified activity: A preliminary investigation. Phys Ther 2004: 84: 49-61
N = 46, 15 female, 28.1 (6.2) years (18-40) Treatment = off the shelf orthoses and activity modification for 3 weeks Success = 50% improvement in pain VAS
Intrinsic to foot/ankle: Great toe extension Navicular drop test Relaxed calcaneal stance Rear foot in subtalar joint neutral position Forefoot alignment Ankle dorsiflexion with knee flexed Ankle dorsifexion with knee extended Extrinsic to foot/ankle: Leg-length difference Tibial varus/valgus Q angle Tibial torsion Craig test for femoral torsion Hamsting muscle length
13 Sutlive et al Identification of individuals with PFP whose symptoms improved after a combined program of foot orthosis use and modified activity: A preliminary investigation. Phys Ther 2004: 84: 49-61 Physical examination +LR* (95% CI)
Forefoot alignment: 2°+ valgus 4 (0.7 to 21.9)
Great toe extension: ≤ 78° 4 (0.7 to 21.9)
Navicular drop: ≤ 3mm 2.3 (1.3 to 4.3)
RCSP: ≤ 5° valgus*2 to 5 = significantand all but varus small shift1.9 in (1.0 probability to 3.6)
Hamstring tightness 1.5 (1.0 to 2.3)
Difficulty walking 1.4 (1.0 to 1.8)
Sutlive et al Identification of individuals with PFP whose symptoms improved after a combined program of foot orthosis use and modified activity: A preliminary investigation. Phys Ther 2004: 84: 49-61 Physical examination +LR* (95% CI)
Forefoot alignment: 2°+ valgus 4 (0.7 to 21.9)
Great toe extension: ≤ 78° 4 (0.7 to 21.9)
Navicular drop: ≤ 3mm 2.3 (1.3 to 4.3)
RCSP: ≤ 5° valgus*2 to 5 = significantand all but varus small shift1.9 in (1.0 probability to 3.6)
Hamstring tightness 1.5 (1.0 to 2.3)
Difficulty walking 1.4 (1.0 to 1.8)
Sutlive et al Identification of individuals with PFP whose symptoms improved after a combined program of foot orthosis use and modified activity: A preliminary investigation. Phys Ther 2004: 84: 49-61 Physical examination +LR* (95% CI)
Forefoot alignment: 2°+ valgus 4 (0.7 to 21.9)
Great toe extension: ≤ 78° 4 (0.7 to 21.9)
Navicular drop: ≤ 3mm 2.3 (1.3 to 4.3)
RCSP: ≤ 5° valgus*2 to 5 = significantand all but varus small shift1.9 in (1.0 probability to 3.6)
Hamstring tightness 1.5 (1.0 to 2.3)
Difficulty walking 1.4 (1.0 to 1.8)
14 Sutlive et al Identification of individuals with PFP whose symptoms improved after a combined program of foot orthosis use and modified activity: A preliminary investigation. Phys Ther 2004: 84: 49-61 Physical examination +LR* (95% CI)
Forefoot alignment: 2°+ valgus 4 (0.7 to 21.9)
Great toe extension: ≤ 78° 4 (0.7 to 21.9)
Navicular drop: ≤ 3mm 2.3 (1.3 to 4.3)
RCSP: ≤ 5° valgus*2 to 5 = significantand all but varus small shift1.9 in (1.0 probability to 3.6)
Hamstring tightness 1.5 (1.0 to 2.3)
Difficulty walking 1.4 (1.0 to 1.8)
PFPS, mobile feet & foot
orthoses: an RCT
Musculoskeletal Pain & Injury Research Unit
Professor Bill Vicenzino1
Kathryn Mills1,2, Peter Blanch2, Priya Dev3 and Professor Michael Martin3
Linkage Grant 1 2 LP0668233 University of Queensland Australian Institute of Sport 3Australian National University
15 Foot orthoses are used in clinical practice
Orthoses are an efficacious treatment option compared with other treatment modalities (Collins et al 2008, Eng and Pierrynowski 1993)
Orthoses v flat insert @ 6 weeks NNT 4 (95% CI 2 to 51)
Foot orthoses are used in clinical practice
Orthoses are an efficacious treatment option compared with other treatment modalities (Collins et al 2008, Eng and Pierrynowski 1993)
Orthoses v flat insert @ 6 weeks NNT 4 (95% CI 2 to 51)
Criteria for preliminary CPR to predict success @ 12 weeks: Foot width WB-NWB diff > 11mm Age >25 years Height < 165 cm Pain severity < 53 mm (Vicenzino et al., 2010)
Foot orthoses are used in clinical practice
Orthoses are an efficacious treatment option compared with other treatment modalities (Collins et al 2008, Eng and Pierrynowski 1993)
Orthoses v flat insert @ 6 weeks NNT 4 (95% CI 2 to 51)
Natural history?
Criteria for preliminary CPR to predict success @ 12 weeks: Foot width WB-NWB diff > 11mm Age >25 years Height < 165 cm Pain severity < 53 mm (Vicenzino et al., 2010)
16 Are orthoses more efficacious than wait-and-see?
Investigate the short-term clinical efficacy of orthoses over natural history
Explore if measures of foot posture and mobility are able to predict treatment success
Methodology Participants: n=40
Mills K, Blanch P, Dev P, Martin M, Vicenzino B. A randomised control trial of short term efficacy of in-shoe foot orthoses compared to a wait and see policy for anterior knee pain and the role of foot mobility. Br J Sports Med. 2011. (accepted)
Methodology Participants: n=40
• Age 18-40 years • No surgery or injury to the lower limb, pelvis or back • No orthoses for the past 5 years • Anterior or retropatella pain • >6 weeks duration • Aggravated by stairs, hills, running, jumping/hopping, squats, kneeling/sitting for extended periods • Pain on palpation of the patella facet, or on deep squat • No other damage or injury to knee structures
17 Methodology Participants n=40
Baseline session
Outcome • Kujala Patellofemoral Score measures • Usual and worst pain severity (secondary) • Patient specific functional scale
Foot Assessment Platform
McPoil et al (2009) Foot posture and mobility measures J Foot & Ankle Res
McPoil et al (2009) Foot posture and mobility measures J Foot & Ankle Res
Midfoot width mobility
Midfoot width Midfoot width non- weight bearing weight bearing
Arch height mobility
Dorsal arch height Dorsal arch height weight bearing non-weight bearing
18 Methodology Participants n=40
Baseline session
Foot orthoses n=20 Control n=20
Wait-and-see policy
Methodology Participants n=40
Baseline session
Foot orthoses n=20 Control n=20
No of women 15 (75%) 14 (70%) p=0.731
Age years 30.4 (5.47) 28.5 (5.89) p=0.285
Height cm 167.5 ( 16.0) 172.6 (8.9) p=0.227
Weight kg 78.16 (12.7) 70.5 (10.8) p=0.709
Worst pain mm 50.3 (20.2) 56.6 (19.4) p=0.317
Usual pain mm 21.95 (20.2) 31.9 (20.69) p=0.073
KPS 84.7 (7.97) 80.7 (6.92) p=0.170
Orthosis prescription was based on comfort
Jog (self-selected Shore A constant speed) 3 minutes 75 Shoe
Most comfortable 60 (highest ranking) orthosis 52
Jog (self-selected constant speed) 3 minutes Orthosis
19 Methodology Randomised n=40
Baseline session
Foot orthoses n=20 Control n=20
Follow-up (6 weeks) Follow-up (6 weeks) n=19 n=20
Primary outcome • Global improvement scale measures • Kujala Patellofemoral Score Secondary outcome • Usual and worst pain severity measures • Patient specific functional scale
Global improvement scale
Completely recovered
Much improved
Improved
No change
Worse
Much worse
Global improvement scale
Completely recovered Success Much improved
Improved
No change No success Worse
Much worse
20 Global improvement scale: Results
100% 1 Success
80% 9 Success
60% 19 Non-Success 40%
10 Non-Success 20%
0% Orthoses Control
Global improvement scale
Completely recovered Improved Much improved
Improved
ISQ No change
Worse Worse Much worse
100% 4 Improved
80%
60% 15 Improved 15 ISQ 40%
20% 4 ISQ 1 worse 0% Orthoses Control
21 NNT: 2 (95%CI 2 to 7)
100% 1 Success
80% 9 Success
60% 19 Non-Success 40%
10 Non-Success 20%
0% Orthoses Control
Predictive value of foot measures
• Foot length
• Midfoot width in weight bearing
• Midfoot width in non-weight bearing
• Arch height in weight bearing
• Arch height in non-weight bearing
• Difference in arch height
• Foot mobility magnitude (√ diff arch height2 + diff midfoot width2)
Midfoot width diff: 11.25 mm (classification tree analysis)
100% 1 2
80%
60% 7
6 13 40% 8
20% 2 0% Mobile Not-Mobile Mobile Not-Mobile Orthoses Control
22 Midfoot width diff: 11.25 mm NNT: 1 (1 to 3)
100% 1 2
80%
60% 7
6 13 40% 8
20% 2 0% Mobile Not-Mobile Mobile Not-Mobile Orthoses Control
Midfoot width diff: 11.25 mm NNT: 2 (1 to 8)
100% 1 2
80%
60% 7
6 13 40% 8
20% 2 0% Mobile Not-Mobile Mobile Not-Mobile Orthoses Control
Function not pain most responsive
23 Orthoses are an efficacious treatment option
Comfortable in-shoe foot orthoses produce short-term improvements beyond that of natural history
Improvements appear to be primarily functional and pain may be slower to resolve
Patients with a mobile midfoot are likely to have increased success rate if they are prescribed with an orthosis
Musculoskeletal Pain & Injury ARC Research Unit Linkage Grant LP0668233
24
PART B:
Background overview of ankle and foot structure and function/dysfunction: gait Clinical reasoning in gait & Gait analysis Structure
Function
Dysfunction
Context
•Musculoskeletal practice •Overuse injuries •Minor motion imbalances •Focus on the foot/ankle complex •Comparative approach: walk-run
Talocrural joint Dorsiflexion (10°) & plantarflexion (20°) Normal total range values: 44-70°
Close pack: dorsiflexion
Talar anteroposterior glide - dorsiflexion Talar posteroanterior glide - plantarflexion Subtalar Joint
Supination-Pronation tri-planar motion ROM: 20°-65° (mean = 40°)
Torque conversion: calcaneum-tala-tibia Axis variation: High axis = abd-add > inv-ev Low axis = inv-ev > abd-add
Midtarsal Joint
Oblique and Longitudinal axes
Subtalar - mid-tarsal joint relationship
Metatarsal Phalangeal Joints (Fig 4.15, p 69) Perry J. Gait Analysis: Normal and pathological function. Thorofare, NJ: Slack Inc; 1992. Fig 1.2 page 5: Perry J. Gait Analysis: Normal and pathological function. Thorofare, NJ: Slack Inc; 1992.
Fig 4.16 page 70: Perry J. Gait Analysis: Normal and pathalogical function. Thorofare, NJ: Slack Inc; 1992. Ankle & foot motion in gait:
•Sagittal Plane
•Transverse / Frontal Plane
Perry J. Gait Analysis: Normal and pathological function. Thorofare, NJ: Slack Inc; 1992. p53 Mann et al, Comparative electromyography of the lower extremity in jogging, running and sprinting. Am. J. Sports Med. 1986;14:501-10.
Knee motion during gait:
•Sagittal Plane
•Transverse / Frontal Plane
Perry J. Gait Analysis: Normal and pathological function. Thorofare, NJ: Slack Inc; 1992. p91 Mann et al, Comparative electromyography of the lower extremity in jogging, running and sprinting. Am. J. Sports Med. 1986;14:501-10.
Hip/pelvic motion during gait:
•Sagittal Plane
•Transverse / Frontal Plane
Perry J. Gait Analysis: Normal and pathological function. Thorofare, NJ: Slack Inc; 1992. p91 Mann et al, Comparative electromyography of the lower extremity in jogging, running and sprinting. Am. J. Sports Med. 1986;14:501-10.
Phase shift as increase speed.
Note foot strike differences between walk and run
Clinical implications:
• Lack of hip motion (eg, extension or internal rotation) impedes hip function - loads back and lower limb
• Lack of control of rotation results in increased range of motion (eg, excessive internal rotation, tilt) - loads muscles and joints
• Treatment guided by viewing the gait pattern, then evaluating active and passive motion and muscle function in physical examination. Clinical implications:
•Specificity of muscle contraction type during rehabilitation •Shock absorption and protective function •Importance of trunk and hip muscles in sprinting •Lift off rather than Push off?
Clinical Significance:
• Gait, especially walking, is a basic function necessitating a sound level of knowledge of the motions, muscle activations and mechanisms of gait. • Important to analyse gait if client presents with an ambulatory problem - make sure that it is relevant to the client. • Dysfunction will be the focus of next session. :,lL _ l ~ ~ - ~ p:::n:~-~ ~~LJ =: ~ 3' ~+" "''' ~ ' ''''''''' ' '''' =4''''''' T ''''' ' J I ' , I I : I ,
l :: -,-- 10% I 20% I ~ ~ I = J. I 70% I w% :~ ~ t . ~ . ~.. ~ . ~ :· ~e;~ . ~~~~:~~:.;~;:--·~t~ .==: ~ ::~ ) m .... m § 6" ....J.--...: _ • .::...... -.....J 0: 1O'r. 20% 6O"h 7[1%
Patient position: Prone lYing In figure 4 posilion. Ensure rear surface of heel parallel to floor.
Therapist position: Seated with foot at about mid section. Overlookmg distal leg.
Procedure: Identify the medial and lateral extent of calcaneum. Approximate the mid pOint (bisector). Place dots on bone (ie above fat pad and not on tendon).
Indications and notes: 1. Joming the dots defines two vectors by which rearfoot angulation to distal leg IS possible. 2. Use white tape under black dot to form markers for video recordings.
Student class notes: Clinical Gait Analysis: Practical Tips
Clinical Gait Analysis: Practical Tips 1. High Sample Rate due to Small Movements & Large Variability 2. Get approximately 10 strides at steady pace 3. Care with Plane of Observation 4. Normal or increased speed not slower 5. Footwear - on/off/compare? 6. Treadmill requires training/familiarisation 7. Video • Alignment • Lighting • Skin Markers
PART C:
Orthoses, overuse injuries (PFP) and the treatment direction test (TDT)
Overuse injury defined:
• Occurs when a structure is exposed to a repetitive force beyond its abilities to withstand such a force (Stanish 1984) • Intrinsic injury • Chronic repetitive activity or acute onset repetitive activity
Lower Limb Overuse Injuries A significant problem • High Prevalence in fitness activities (e.g., jogging, aerobic gym work outs, cycling, etc) • Impedes performance • Interferes with participation
Many lower limb overuse injuries have been putatively associated with abnormal lower limb biomechanics such as excessive pronation
How valid is that association?
Study type
(1) Cross sectional
(2) Longitudinal (prospective, retrospective)
1 Lysens RJ et al (1989) The accident prone and overuse prone profiles of the young athlete, Am J Sports Med 17: 612-9
Prospective longitudinal study of 185 (118 male, 67 female) aged 18.3 ± 0.5 yrs.
Muscle weakness, ligamentous laxity & muscle tightness intensified by large body weight and height, high explosive strength and malalignment of the lower limbs (female>male)
How valid is that association?
Willems, T.M., et al., A prospective study of gait related risk factors for exercise- related lower leg pain. Gait & Posture, 2006. 23(1): p. 91-98.
(1) a significantly more central heel-strike (2) a significantly increased pronation (3) accompanied with more pressure underneath the medial side of the foot (4) a significantly more lateral roll-off
Overuse injuries: classification
Phase I: pain during, may go with warming up, or be present for short while later Phase II: pain during exercise, not subsiding, present later, but not interfering with ADL
Phase III: pain starting to limit physical activity and in ADL Phase IV: pain interfering with ADL, consistent if not constant symptoms
2 Diagnostic based guidelines: Phase I & II: • Treat and train while deloading tissues
Phase III & IV: • Cease activity that produced pain/ injury • Attend to pain ± inflammation as priority • Deload tissues as a means relieving pain and encouraging normal function
Risk factors:
• Training 1,3 • Equipment 1,3 • Environment 1,3 • Biomechanical 2,3
1. Extrinsic factors largely checked in interview
2. Intrinsic factor examined physically
3. Must be checked in clinical examination
Relative Risk of Injury Biomechanical Factor Environmental Factor Equipment Factor
Training Error Multifactorial Mix of Risk Factors (proportional) Risk Factorsof (proportional) Mix Multifactorial
Training Error Increased (eg, load, heavy weights, less rest)
3 Training factors
• Too much too soon • Too much load • Too little rest • Poor preparation for heavy work • Plyometric • Change in technique
Equipment Factors
• Footwear
• Heel cup (vertical, firm, snug)
• Flexibility at MTP joint
• Fit
• Age of shoe and amount of wear • Bike set up for cyclists
4 [http://www.biomedcentral.com/content/supplementary/1757- 1146-2-10-S1.zip]
[http://www.biomedcentral.com/content/supplementary/1757- 1146-2-10-S1.zip]
Environment Factors
• Camber of surface • Firmness / compliance of surface • Temperature and humidity • Hilly or flat
5 Biomechanical Factors
• Skill technique • Bony alignment • Joint motion • Muscle • Strength (eg, weakness, endurance) • Tightness • Coordination
LL kinetic chain: foot …
Gotz-Neumann (2002) cited in Powers (2003)
Clinical biomechanics of PFPS:
6 Clinical biomechanics of PFPS:
Clinical biomechanics of PFPS:
Stresses causing pain
Clinical biomechanics of PFPS:
Some Local Causes of valgus vector: • Bony dysplasia • Weak VMO • Tight lateral structures
7 Clinical biomechanics of PFPS:
Some Distant Causes of valgus vector: = IR & ADD @ hip: • Bony torsion • Weak hip ERors • Tight hip IRors • Foot pronation
8 Witvrouw E et al (2000) Intrinsic risk factors for the development of anterior knee pain in an athletic population: a 2 year prospective study. Am J Sports Med 28(4): 480-9
Sample: 282 physical education students (131 female)
18.6 years old (17-21 yr range)
All enrolled in a similar physical activity program of approximately 12-14 hours sport per week
All previously asymptomatic and examined at entry into study
9 Witvrouw E et al (2000) Intrinsic risk factors for the development of anterior knee pain in an athletic population: a 2 year prospective study. Am J Sports Med 28(4): 480-9 1. Explanatory variables: 2. Anthropometric variables (height, weight, body fat%, body composition) 3. Physical fitness (Eurofit test, submaximal ergometer test) 4. General joint laxity (thumb to forearm, elbow, knee, shoulder and little finger hyperextension, patella mediolateral mobility with quads relaxed and knee extended measured in mm) 5. Lower leg alignment (leg length difference, foot alignment - arch height, forefoot and rearfoot alignment) 6. Muscle length and strength (hamstring, quads and gastrocnemius muscle length, isokinetic strength of hamstings and quads) 7. Static patellofemoral characteristics: Q-angle, genu varum/ valgum 8. Dynamic patellofemoral characteristics: tendon reflex response latency 9. Psychological parameters: coping mechanisms, intro/ extroversion, neurotic and psychosomatic lability
Incidence of PFPS = 9% or 24/282
Female 10%(13) Male 7%(11)
11/24 had bilateral PFPS
PFPS defined as:
>6 week duration of symptoms Symptoms = retropatellar pain with activities such as jumping, running, squatting, stair climbing
2 of the following clinical signs: PF compression in Knee Ext, +ve Clarke’s sign, pain to palpation posterior patella, resisted Knee Ext, and -ve findings for other knee problems (e.g., ligaments, menisci, etc).
Witvrouw E et al (2000) Intrinsic risk factors for the development of anterior knee pain in an athletic population: a 2 year prospective study. Am J Sports Med 28(4): 480-9 Significant contributors to PFPS (logistic regression)
Reduced quadriceps flexibility (injured:125±13 / control: 132±16; measured with PKB with other hip flexed to 90 degrees)
Shortened reflex response for VMO
Reduction in explosive strength, that is, in vertical jump performance (injured:53±4 / control: 56±6cm)
Statistical differences existed in additional variables:
Gastrocnemius length (injured:32±5 / control: 35±7, weight bearing)
Thumb-forearm flexibility
Reflex response of VL as well as VMO above
Psychological parameter of seeking social support
NOT Q-angle (PFPS 11.5±6.2, Control 13.0±7.7°)
10 Relative Risk of Injury
BIO } EN EQ
TE Multifactorial Mix of Risk Factors (proportional) Risk Factorsof (proportional) Mix Multifactorial
Both Options
Advice and education
• Training error
• Periodisation
• Cross training
• Consult with coach/athlete • Equipment faults
• What to look for in a shoe
• Shoe rotation
11 Shoe advice to client:
• Heel cup • Firm • Vertical • Snug • Extension at MT-P joint • Fit • Last shape and foot type? • Gimmicks, fads and R&D!
Advice and education
• Training error • Periodisation • Cross training • Consult with coach/athlete • Equipment faults • What to look for in a shoe • Shoe rotation
• Environmental faults • Surface compliance and slope • Biomechanical faults in skill (eg, jogging) • Role for the run coach
12
PART D:
Orthoses selection reasoning, TDT and fitting lecture 1. Overuse injuries defined, predisposing (risk factors) & treatment
2. Who is likely to need an orthotic 3. How to fit an orthotic 4. What do you do for those who are not likely to need an orthotic
‘Custom’ foot orthoses
measures taken from foot representation of foot
http://www.footorthotics.com/products.html
http://www.foot-health.info/orthotics/
Off-the-shelf foot orthoses
‘pre-fabricated’
http://www.vasyli.com/brands/medical.html
http://www.formthotics.co.nz Sutlive et al Phys Ther 2004: 84: 49-61
1 Foot orthoses in lower limb overuse injuries: Collins et al (2007)
? Quality of current level 1 evidence
Prevention Foot orthoses over simple insoles Foot orthoses over control? Treatment Can’t rely on current evidence base Need to look at other levels of evidence
No evidence of an effect of custom over prefabricated foot orthoses
How do Landorf K, Keenan A-M, Rushworth RL podiatrists (2001) Foot orthosis prescription habits make of Australian and New Zealand Podiatric Physicians, J Am Pod Med decisions Assoc. 91(4): 174-183. regarding orthosis Surveyed 1505, with response rate of use? ~40%.
12% pre-fabricated & 72% customized - majority (73%) were Root-type & majority balanced to Neutral sub-talar position
6 times more likely to prescribe Root- type orthoses
Root ML, Orien WP, Weed JH, Hughes RJ (1971) Biomechanical examination of the foot (Volume 1) Los Angeles Ca: Clinical Biomechanics Corp. Root ML, Orien WP, Weed JH (1977) Abnormal function of the foot (Volume 2) Los Angeles Ca: Clinical Biomechanics Corp.
2 Root et al normal foot alignment
Neutral STJ
MTJ locked
Root ML, Orien WP, Weed JH, Hughes RJ (1971) Biomechanical examination of the foot (Volume 1) Los Angeles Ca: Clinical Biomechanics Corp. Root ML, Orien WP, Weed JH (1977) Abnormal function of the foot (Volume 2) Los Angeles Ca: Clinical Biomechanics Corp.
1. Determine if any intrinsic deformity exists 2. Measure amount of deformity 3. Cast foot to capture degree of deformity 4. Construct functional orthoses (± posts)
McPoil TG, Hunt GC. Evaluation & Management of Foot & Ankle Disorders - Present Problems & Future- Directions. JOSPT 1995;21(6):381-88.
• Measurement technique reliability • Criteria proposed for normal foot alignment • The position of the rearfoot at mid- stance during walking = neutral alignment
3 McPoil T, Cornwall, MW, Relationship between Neutral Subtalar Joint Position & Pattern of Rearfoot Motion During Walking, Foot & Ankle Int, 15 (1994) 141-145
25 year olds, 62 feet
Challenges the validity of Root et al defined normal alignment during gait. SLS or relaxed stance approximates rearfoot position during walking.
McPoil TG, Hunt GC. Evaluation & Management of Foot & Ankle Disorders - Present Problems & Future- Directions. JOSPT 1995;21(6):381-88.
• Questionable validity, due to:
• Poor reliability of measures
• Normal foot alignment is not normal
• Mid-stance rearfoot position is not STJ neutral • Proposed a tissue-stress model for therapists to use.
McPoil TG, Hunt GC. Evaluation & Management of Foot & Ankle Disorders - Present Problems & Future- Directions. JOSPT 1995;21(6):381-88.
Tissue stress model
4 McPoil TG, Hunt GC. Evaluation & Management of Foot & Ankle Disorders - Present Problems & Future- Directions. JOSPT 1995;21(6):381-88.
1. Identify tissues being stressed (interview) 2. Physical examination (i.e., stress tissues) to confirm tissues as source of symptoms 3. Determine the pathomechanics/etiology of the presenting condition. 4. Institute treatment that: a) reduce tissue stress (rest, footwear, orthoses) b) modalities to assist healing c) restore muscle length and flexibility
Vicenzino B (2004) Foot orthoses in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Manual Therapy, 9:185-96
Smith M, Brooker S, Vicenzino B, McPoil T, (2004) Use of anti-pronation taping to assess suitability of orthotic prescription: Case report. Australian Journal of Physiotherapy, 50: 111-13.
• 32 year old male
• Competitive soccer player
• Achilles tendinopathy II+
• 2 year history of the condition
• Aggravated by soccer, jogging & netball
5 Smith M, Brooker S, Vicenzino B, McPoil T, (2004) Use of anti-pronation taping to assess suitability of orthotic prescription: Case report. Australian Journal of Physiotherapy, 50: 111-13.
• TOP over Achilles tendon
• Prolonged & excessive pronation determined by clinical observation
• CSOM: Run to pain threshold = 103m
TDT Step 1: client specific outcome measure
Practitioner
1. Determines that there is some movement abnormality that plausibly relates to symptoms
2. To do this there has to be some modeling of how the abnormal movement leads to excessive stress
6 TDT Step 2: Physical Manipulation
Mechanical effects
TDT Step 3: Re-evaluate
Smith M, Brooker S, Vicenzino B, McPoil T, (2004) Use of anti-pronation taping to assess suitability of orthotic prescription: Case report. Australian Journal of Physiotherapy, 50: 111-13.
14xSD
7 Bisset L, O’Meara T, Vicenzino B, McPoil T, (unpublished) Role of TDT in predicting effects of orthoses in medial tibial stress syndrome.
• 38 year old male • Triathlete • Normally able to run 10km painfree • 12 week history of shin pain • Pain aggravated by 3 min. jogging - • MTSS phase III
Effect on pain and function appears to be most critical element in successful management by orthoses, not movement correction.
Vicenzino B (2004) Foot orthoses in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Manual Therapy, 9:185-96
Are foot orthoses required?
Based on results of TDT?
8 Modification of McPoil & Hunt Tissue-Stress Model
1. Identify tissues being stressed (interview) 2. (a) Physical examination (i.e., stress tissues) to confirm tissues as source of symptoms (b) Treatment Direction Test if orthosis needed 3. Determine the pathomechanics/etiology of the presenting condition. 4. Institute treatment that:
a) reduce tissue stress (rest, footwear, orthoses)
b) modalities to assist healing
c) restore muscle length and flexibility
Vicenzino B (2004) Foot orthoses in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Manual Therapy, 9:185-96
Physical Manipulation in TDT & Orthotic type is based on gait abnormality:
Excessive pronator or Supinator
Supinator:
9 Supinator TDT/orthotic:
Exclude first ray
Proximal to MTP joints
Distal to Cuboid- 4/5th rays joint
Supinator orthotic:
10 Vicenzino B (2004) Foot orthoses in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Manual Therapy, 9:185-96
Physical Manipulation in TDT & Orthotic type is based on gait abnormality:
Excessive pronator or Supinator
Excessive pronation:
http://www.formthotics.co.nz
http://www.vasyli.com/brands/medical.html
Sutlive et al Phys Ther 2004: 84: 49-61
http://www.footorthotics.com/products.html
Excessive pronation:
Loading response: excessive pronation
11 Effective at controlling pronation
Tape
External physical devices: Tape Treatment direction testing
• Pre-requisite to orthotic therapy in most cases
• Only worthwhile with excessive pronation, not lack of pronation Short term use - usually, some exceptions
• May be used in cases where orthotics not suitable (eg, ballerina, sprinter, gymnast)
• De-load stressed tissues
Tape
• Not good with • Bony lack of TC dorsiflexion • Forefoot varus • Adverse effects • Skin reactions • Allergy or Traction injury of skin • Signs and symptoms • Skin tests • Warnings
12 Temporary anti-pronation orthotic:
Vicenzino B, Griffiths S, Griffiths L, Hadley (2000) Effect of antipronation tape and temporary orthotic on VNH before and after exercise. JOSPT 6: 333-339. Tape and felt padding have similar effect on arch height
Orthotic therapy options: Off the shelf mouldable:
Rigid customised fabricated by practitioner:
13 Guidelines for fitting: background Biomechanical effects are small, non-systematic and highly variable (Nigg 2007) and should be used with care in fitting.
Nigg review (1999) “…based on this concept, an optimal insert or orthotic would reduce muscle activity, feel comfortable, and should increase performance.”
Main adverse effect is discomfort, which led to discontinuation in most cases (Collins et al 2007)
Guidelines for fitting:
• Comfort • Performance
“…based on this concept, an optimal insert or orthotic would reduce muscle activity, feel comfortable, and should increase performance.” (Nigg et al 1999)
Guidelines for fitting:
• Comfort • Performance
• Variables: • Volume of orthosis • Length of orthosis • Density or firmness of orthosis • Additions and modifications to orthosis
14 Length of orthoses
SIZE & FIT?
8-10mm proximal to MTP
Guidelines for fitting:
Comfort First: …tested during weight bearing task
1. Appropriate and adequate footwear 2. Select orthoses to footwear (volume) 3. Fit orthoses to foot (length) 4. Heat mold/grinding 5. Additions
Guidelines for fitting: then Performance …tested during client specific outcome measure / functional task
1. Appropriate and adequate footwear 2. Select orthoses to footwear (volume) 3. Fit orthoses to foot (length) 4. Heat mold/grinding 5. Additions*
* McPoil uses the TDT induced change in dorsal arch height as the guide for orthotic additions
15 Guidelines for fitting: No measure of foot form, mechanics, motion or orthosis-paradigmatic related measures
Overarching principle: Heat moulding, wedges, raises, grinding, etc EPD = comfortable
EPD = comfortable & pain-free CSOM Mechanical effects appear to be 2ndary consideration
Modified McPoil & Hunt Tissue-Stress Model 1. Identify tissues being stressed (interview) 2. (a) Physical examination (i.e., stress tissues) to confirm tissues as source of symptoms & to identify the physical impairments that you may wish to treat (b) Treatment Direction Test if orthosis needed 3. Determine the pathomechanics/etiology of the presenting condition. 4. Institute treatment that: a) reduce tissue stress (rest, footwear, orthoses) b) modalities to assist healing c) restore muscle length and flexibility
16 Treatment options:
• Manual therapy • Joint and soft tissue manipulation • Talocrural joint • Subtalar joint • Mid tarsal joint • Calf muscles • Thigh fascia
Treatment options:
• Exercise
• Control
• Specific postural sets (A.P.E. & A.P.E.D)
• use of biofeedback such as EMG
• Endurance
• Stretching
• Strength
• Power • Therapeutic exercise course
Vicenzino B (2004) Foot orthoses in treating lower limb conditions: A musculoskeletal physio. perspective. Manual Therapy 9: 185-96
17 Treatment options:
• Electro-physical agents • Heat soft tissues pre-stretching • although exercise is more effective at this • Pain gating • TENS like electrotherapy • Anti-inflammatory • only if signs of inflammation remembering that in chronic tendinopathy there are few signs of inflammation so pain is coming from some other source • Accelerated healing • Dubious claims, little evidence
Some examples of clinical presentations that may not fully respond to the foot orthotic:
Excessive internal rotation of the hip and thigh in mid-stance (eg, as in PFPS):
• tape at the hip joint • exercises for the external rotators (Brolga) • stretches for tight internal rotators
Some examples of clinical presentations that may not fully respond to the foot orthotic:
Poor control of patellofemoral joint with weak/poorly activated/delayed onset VMO as in PFPS:
• tape at the patellofemoral joint • exercises for VMO (EMG, squat) • stretches for tight lateral structures such as lateral retinaculum or iliotibial band (self, therapist- massage/ mobilisation)
18 Some examples of clinical presentations that may not fully respond to the foot orthotic: Lack of talocrural dorsiflexion that isn’t bony (which would respond to heel raise):
• Anti-pronation tape at the foot not very effective - especially if reduces in biomechanical effect very quickly • Specific exercises to stretch calf - foot in supinated position (anti-pronation exercise) • Manual therapy for calf or ankle joint
Some examples of clinical presentations that may not fully respond to the foot orthotic: Supinated type foot, especially rigid:
• Supinator pad only partly effective • Manipulative therapy to improve range of motion at the sub-talar joint (± mid tarsal if tight) • Orthotic with increased shock absorption and possibly motion enhancing?
Some examples of clinical presentations that may not fully respond to the foot orthotic: Hyper-flexible foot:
• Anti-pronation taping only part effective • Exercises of intrinsic foot muscles
• Must do in good posture
• May need some posting/wedging?
19
PART E:
Integrating orthoses within the physical therapy treatment plan Should an orthoses be used?
What kind of an orthosis is required?
Where do orthoses fit within the treatment plan (concomitant therapies?)
Clinical efficacy Evidence in literature:
Are foot orthoses required?
Vicenzino B (2004) Foot orthoses in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Manual Therapy, 9:185-96
Are foot orthoses required?
What is the likelihood of success?
1 Case example: anterior knee pain
• 30 yr old chronic AKP • CSOM 4 stairs to Pain threshold • TDT 62 steps • Followed up with orthoses in next 6 weeks
ALD TDT example
Case example:
• Chronic Ankle Instability: mid foot pain - deep and diffuse • 24 month duration • Routine rehabilitation not resolve issues completely • Gait down stairs, uneven surfaces and down slopes/hills (unable to perform latter due to pain and instability) • Supinator TDT allowed downstairs walking symptom free • Followed up with supinator pad on innersole (no orthoses was comfortable, so only used pad)
Movement correction is only part of the solution in successful use of foot orthosis, effect on pain and function is possibly most critical.
2 Treatment Direction Tests Applied:
• Several circumstances encountered: • In clinic • Standing or Sit to Stand • Walking or jogging (approx. < 5 minutes) • Runner or long time for onset • Apply tape and send out to re-test • Send out for run and examine at time of pain • Or both? • Other • BEWARE of client who is unsure of aggravating factor and dysfunction (ie don’t know when pain is a problem!)
Collins N, Bisset L, McPoil T, Vicenzino B. (2007) Foot orthoses in lower limb overuse conditions: A systematic review and meta- analysis. Foot & Ankle International, 28(3): 396-412.
? Quality of current level 1 evidence
Prevention Foot orthoses over simple insoles Foot orthoses over control?
Treatment Can’t rely on current evidence base Need to look at other levels of evidence
No evidence of an effect of custom over prefabricated foot orthoses
Root ML, Orien WP, Weed JH, Hughes RJ (1971) Biomechanical examination of the foot (Volume 1) Los Angeles Ca: Clinical Biomechanics Corp.
Root ML, Orien WP, Weed JH (1977) Abnormal function of the foot (Volume 2) Los Angeles Ca: Clinical Biomechanics Corp.
1. Determine if any intrinsic deformity exists 2. Measure amount of deformity 3. Cast foot to capture degree of deformity 4. Construct functional orthoses (± posts)
3 McPoil TG, Hunt GC. Evaluation & Management of Foot & Ankle Disorders - Present Problems & Future- Directions. JOSPT 1995;21(6):381-88.
• Questionable validity, due to: • Poor reliability of measures • Normal foot alignment is not normal • Mid-stance rearfoot position is not STJ neutral • Proposed a tissue-stress model for therapists to use.
McPoilParadigm TG, Hunt of pathomechanics: GC. Evaluation & ManagementTissue-Stress of Footmodel & Ankle Disorders - Present Problems & Future- Directions. JOSPT 1995;21(6):381-88.
Tissue stress model
Modification of McPoil & Hunt Tissue-Stress Model
1. Identify tissues being stressed (interview) 2. (a) Physical examination (i.e., stress tissues) to confirm tissues as source of symptoms (b) Treatment Direction Test for orthosis 3. Determine the pathomechanics/etiology of the presenting condition. 4. Institute treatment that: a) reduce tissue stress (rest, footwear, orthoses) b) modalities to assist healing c) restore muscle length and flexibility
4 Some key points in fitting:
1. Comfort 2. Treatment Direction Test
Some key points I look out for:
• Size - leading edge of 3/4 device / MTP break area • Arch area • Lateral edge
Some challenges with orthoses:
• Adverse effects
• Less than full resolution of the symptoms/condition
Assuming a positive TDT
5 Adverse or side effects: Local at foot-orthotic interface • MTP region, Arch …
At distance from foot-orthotic interface • Displacing stress from the site of pain to a new site (eg, lower limb to lumbar spine, foot to knee or hip)
Adverse or side effects:
Distal to foot by displacing stress to new site: • Perhaps (?) due to: • Overcorrection (correction) of abnormal motion/force dissipation at the pain/injury site • Unyielding underlying cause of abnormal motion • Limb length inequality (functional, structural) • Boney faults (torsions, valgus/varus, length)
How determined a-priori? (next slide …)
Adverse or side effects: How determined a-priori? • Evaluation: • History • Physical exam: • Observation of CSOM - movement patterns • Comparing nwb to wb assessment • Assessment of bone, joint and muscle systems • Response to TDT: examples • Pulling on shin with tape • Pain, discomfort or stress elsewhere • Observation of abnormal motion pattern
6 If orthoses: • 100% improvement then no other treatment • < 100% improvement then need to look at other treatment
based on data collected on physical evaluation of bone, joint and muscle systems (neural?)
Clinical Reasoning: possible causes of abnormal pronation in Achilles example?
• Lack of talocrural dorsiflexion • Calf tightness • Joint limitation • Bony limitation • Forefoot varus (yielding or non-yielding) • Hypermobile midtarsal joint (subtalar) • Poor muscle control of foot (Int, TP, PL) • NB: causes extrinsic to the foot, eg: • Poor pelvic control (excessive IR) • Genu valgum or varum • Tibial varum, or torsion
Clinical Reasoning: possible multifactorial causes of Achilles tendon pain?
• Training Error • Too much too soon • Plyometrics with poor preparations • Equipmental faults • Old shoes • Inadequate control • Environmental faults • Too quick an intro into hills • Beach sand running (soft, cambered) • Biomechanical faults
7 Clinical Reasoning: what to do when more than 1 factor identified?
• Coaching tenet: change the one factor that most impacts on condition ± influences other factors. To do this, to the following: • List the factors that might be at play as elucidated on physical examination (± interview) • Prioritise in terms of severity while considering the ones most amenable to the interventions available to you • Set about systematically modifying factors in ordered, progressive and structured manner.
Plan:
• Physical evaluation & treatment for distal and proximal kinetic chain • Reasons for choosing distal versus proximal kinetic chain approaches • Concept of decision making based on end game scenarios: TDT expanded • The TDT follies …
Treatment options:
• Advice and education • External physical devices • Tape • Orthotics • Exercise • Stretching • Control • Strength, endurance, power • Manual therapy • Joint and soft tissue manipulation • Electro-physical agents
8 Advice & Education:
Threshold for injury
Biomechanical Factors Environmental Factors Equipment Factors
Training & Sport Factors Multifactorial Mix of Risk Factors (proportional) Factors Risk of Mix Multifactorial
temporal
Treatment options:
• Advice and education • External physical devices • Tape • Orthotics • Exercise • Stretching • Control • Strength, endurance, power • Manual therapy • Joint and soft tissue manipulation • Electro-physical agents
Some examples of clinical presentations that may not respond fully to foot orthotic:
Hyper-flexible foot:
• Anti-pronation taping only part effective • Antipronation Exercises • Must do in good posture • May need some posting?
9 Some examples of clinical presentations that may not respond fully to foot orthotic: Lack of talocrural dorsiflexion that is discerned on basis of response to an anti-pronation TDT:
• Substantial discomfort/pain at the skin-tape interface on the anterior shin • An obvious limitation of dorsiflexion, e.g., hyperextension of the knee, tibial retardation in mid-stance • Marked loosening of the tape such that within several gait cycles there is increasing amounts of pronation …
Some examples of clinical presentations that may not respond fully to foot orthotic: Treatment is selected on basis of the cause of dorsiflexion limitation:
Bone: heel raise
Calf muscle tightness: specific exercises to stretch calf (controlling pronation)
Joint restriction: manual therapy: ankle joint
Some examples of clinical presentations that may not respond fully to foot orthotic:
Supinated type foot, especially rigid:
• Supinator pad only partly effective • Manipulative therapy to improve range of motion at the sub-talar joint (± mid tarsal if tight) • Orthotic with increased shock absorption and possibly motion enhancing?
10 Patellofemoral pain syndrome:
Management approaches: • Site of intervention? • Foot-leg region • Pelvic-hip region • Locally at knee
• Where to start?
• TDT?
Some examples of clinical presentations that may not respond to the foot orthotic: Excessive internal rotation of the hip and thigh in mid-stance (eg, as in PFPS):
• tape at the hip joint • exercises for the external rotators (brolga test/manoeuvre) • stretches for tight internal rotators
Some examples of clinical presentations that may not respond to the foot orthotic: Poor control of patellofemoral joint with weak/poorly activated/delayed onset VMO as in PFPS:
• tape at the patellofemoral joint • exercises for VMO (EMG, wall squat) • stretches for tight lateral structures such as lateral retinaculum or iliotibial band (self, therapist-massage/ mobilisation)
11
PART F:
Foot and ankle assessment and treatment practical PART F:
Practical Techniques:
Some techniques covered:
1. TDT of foot and ankle (e.g., low Dye, augmented low Dye)
2. TDT of the hip
3. Examination of the foot and ankle: Weight bearing: Foot form Big toe extension Ankle dorsiflexion Leg-foot alignment Pelvis-thigh alignment (Brolga) Weight bearing versus non-weight bearing: Arch height, width and the difference Non-weight bearing: Range of motion and restraints
RISK MANAGEMENT AND SAFETY ISSUES IN TAPING:
Taping appears to be relatively innocuous in terms of side effects and by and large it is, especially if the therapist considers the following issues. The issues relate to allergic reactions of the skin to the tape and compromise of the neuro-vascular structures coursing through the taped region. To a lesser extent the tendon structures underlying the taped area also need to be considered.
ALLERGIC REACTIONS: There are 2 types of allergic responses: one brought about by the chemical adhesive used to adhere the tape to the skin and the other is one that is most likely due to a traction stress injury of the skin. The differentiating feature of these two types of adverse event is the skin surface area of the allergic response. In the allergy to the adhesive material, the response is widespread under most of the tape whereas in the traction injury the response is localised to that part of the tape where traction was exerted, usually at the start or end of a technique.
Apart from these differences, which are remedied by two different approaches, the actual allergic response is much the same in symptoms and signs that are witnessed.
Symptoms of allergic reaction: • Itchiness • Heat • Pain • Irritability
Signs of allergic reaction: • Redness • Slight raising • Blistering (intact) • Broken blisters and skin • Broken skin
Precautions to take pre-taping: If possible always skin test before applying tape. This involves applying a strip of tape to the area to be taped and left on for a comparable period of time to that which the taping technique will be on for. The client then reports any symptoms of allergic response noting the time taken to bring on the response. The tape should then be carefully removed, proximal to distal and inspected for any signs of allergic reaction. Allergic reaction pretty well excludes the use of tape, although there are a number of products on the market that condition and prepare the skin for adhesive tape and tape with hypoallergenic qualities. The use of these products should be tested first in the same manner as the strip test outlined herein before being used for protracted periods of time.
The skin test would only be of benefit in a situation where the clients were a captive audience prior to the need for using tape, for example, pre-season at a sporting club or centre. The use of the skin test is not always possible in clinic as the decision to apply tape and the application of the tape often occur within the space of 30-45 minutes at the most. In these circumstances other strategies are employed.
When a skin test is not possible the following strategies should be used: • Ask questions about prior experience with adhesive tapes (eg plasters, elastoplast, sports tape) and if there has been allergic responses opt to do a skin test in the first instance. • Query general allergy tendency of the client, that is, do they have skin allergies often to a variety of stimuli (eg dust, detergents) or do they have eczema or are they sensitive to sun? • Ascertain the health of the skin and in particular its healing capabilities remembering that healing is compromised in diabetes sufferers, the elderly, those with peripheral vascular disease (smokers), and after the protracted use of steroids to list a few common conditions. • Observe the skin of the client to ascertain any scars and the extent of the scarring, fairness of skin and presence of eczema and skin irritations. If there is any reason to suspect compromised skin health or susceptibility to allergic responses and poor healing, then DO NOT proceed with taping.
Preparation of the skin is also important: Clean the skin, remove any hair and dirt and ensure there is no broken skin under and in contact with the tape. Apply skin conditioners if required.
Precautions to take during taping: Do not overly traction or compress the underlying tissues especially where the musculotendinous and neuro-vascular structures are superficial or juxtaposed to bony structures. In short, be technically excellent!
Precautions to take post-taping: • Provide a warning notifying the client what an allergic response will feel and look like and that there is a risk of breaking the skin which makes them susceptible to infections, delayed healing and ongoing problems. Hence they are to be diligent in observing their reactions to tape and reporting them to you. • Check immediately after taping and before client leaves your rooms that they are not experiencing symptoms suggestive of allergic response or compromise of circulation (blanching, flushness or blueness and fullness of the distal parts of the limb and digits) or neurological impairment (pins and needles, numbness, possibly pain distal to tape in some conditions). • Check that the tape does not interfere with the functional activities required by the client while still protecting, de-loading or de-stressing the injured structures. • Removal of taping should be done carefully so as not to traction injure the skin, usually involves pulling the tape back on itself in a proximal to distal direction down the limb. Tape techniques: Low Dye Spur: NOTES:
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Mini-stirrups ______
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Spur lock off - medially ______
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Spur lock off - laterally ______
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______Anchor & Locks
Patient position: Supine lying. Slightly supinated at rearfoot with locked midtarsal
Therapist position: Standing with foot below mid section.
Procedure: For anchors, locks and any tape that course transversely about the leg and ankle, make sure the ankle is maximally dorsiflexed.
Indications and notes: 1. Ensure tape goes onto skin without to much tension. 2. Always check for excessive tension by observing and palpating for vascular occlusion. 3. Lay tape on skin (no tension) 4. Note oblique inclination 5. What is the difference between a lock and anchor tape? Student Class Notes: Low Dye
Patient position: Supine lying. Slightly supinated at rearfoot with locked midtarsal If possible, plantarflex first ray and adduct forefoot.
Therapist position: Standing with foot below mid section.
Procedure: 1. Spur: start medially and distal, running posteriorly and around to lateral side. 2. Mini-slings: start lateral side of foot, course underneath foot around to anchor on medial side. 3. Start mini-slings distally and lay each subsequent one covering previous by about 1/2 moving in a proximal direction with each mini-sling. 4. Finish with a spur to lock off onto foot Student Class Notes:
Indications and notes: 1. Note that no tape goes circumferentially around the forefoot! Why? 2. May need to put an anchor across dorsum - do this in standing.
Reverse Six
Patient position: Supine lying. Slightly supinated at rearfoot with locked midtarsal
Therapist position: Standing with foot below mid section.
Procedure: Commence over medial malleolus or proximally course over the anterior ankle region about the cuboid, underneath the foot and importantly then vertically up the leg making sure not to run in a posterior direction.
Indications and notes: 1. The longitudinal component needs to reef up the sustentaculum-tali - navicular regions, so that they do not drop (eg pronate) during weight bearing. Student Class Notes: Why is it called a reverse 6? Calcaneal Slings
Patient position: Supine lying. Slightly supinated at rearfoot with locked midtarsal
Therapist position: Standing with foot below mid section.
Procedure: Start on medial-anterior shin about 1/3rd way up leg course down obliquely over the Achilles Tendon being very careful not to place too much tension on tape and also to have the ankle dorsiflexed. Pass over the calceneum obliquely before finishing off much like a reverse 6. Student Class Notes: Indications and notes: 1. Use about 2 of theses. Augmented low dye
Patient position: Supine lying. Slightly supinated at rearfoot with locked midtarsal
Therapist position: Standing with foot below mid section.
Procedure: Techniques usually applied in this order: (i) Low dye (1) (ii) Anchor (1) (iii) Reverse 6 (3) (iv) Calcaneal slings (2) (v) Locks (3) Student Class Notes: Indications and notes: 1. Temporary trial of external anti-pronation device. 2. Treatment Direction Test. 3. Deload tissues Light anti-pronation tape (example)
Patient position: Supine lying. Slightly supinated at rearfoot with locked midtarsal
Therapist position: Standing with foot below mid section.
Procedure: Combine anchor, 3 reverse 6s and 3 lock offs.
Indications and notes: 1. A low dye technique or just using several calcaneal slings could also be Student Class Notes: regarded as light anti-pronation taping techniques.
Weight bearing Dorsiflexion wall Patient position: Standing. Foot perpendicular to wall with calcaneal bisector and 2nd toe on a line perpendicular to wall. Mid point of the anterior knee to form the 3rd point on a plane that remains vertical to wall.
Therapist position: Ensuring heel and foot position remain ISQ during test.
Procedure: Lunge forward with knee until anterior knee just q touches wall with heel and foot in position above.
Indications and notes: d 1. Measure ‘d’ directly or take a digital image and Student Class Notes: measure ‘q’ from image. 2. Do not allow foot or leg in frontal plane to move out of position. 3. This is a reliable technique for measuring DF and should be used as an outcome measure to track change in dorsiflexion. Forefoot Measures: Movements a b
Patient position: Prone lying in figure 4 position. Sub talar in neutral position.
Therapist position: Seated with foot at about mid section. c Hands pronated. Fix sub talar joint by holding calcaneum.
Procedure: Move cuboid for oblique axis motion (a & b) and navicular for longitutinal axis motion ©.
Indications and notes: 1. Do not allow calcaneum to move. Student Class Notes: Non-weight Bearing Dorsiflexion Limitation Differentiation
Patient position: Supine lying. Foot perpendicular to floor.
Therapist position: Seated with foot at about mid section. Overlooking distal leg.
Procedure: Place rearfoot in sub talar neutral. While maintaining midtarsal joint in a stable position and subtalar joint in neutral dorsiflex the ankle. Indications and notes: 1. Dorsiflex with knee extension (DF in KE) = 10°. 2. If DF in KE <10°, make a judgement of the end feel: is it soft tissue or hard end feel (ie, muscle, joint versus Student Class Notes: bone). 3. If DF in KE <10°, flex knee: if now DF = 10° -> gastroc was limiting DF. 4. If DF in KE <10°, flex knee: if now DF < 10° -> not gastroc limiting DF, use end feel to distinguish boney versus soft tissue (joint vs muscle). 5. This test is not a good outcome measure but it is good to help understand what needs to be treated if DF is limited.
PART G:
Vicenzino B. Foot orthotics in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. Manual Therapy 9 (2004) 185-96 ARTICLE IN PRESS
Manual Therapy 9 (2004) 185–196 www.elsevier.com/locate/math Masterclass Foot orthotics in the treatment of lower limbconditions: a musculoskeletal physiotherapy perspective
Bill VicenzinoÃ
Physiotherapy Division, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland 4072, Australia
Received 30 July 2004; accepted 9 August 2004
Abstract
Orthotic therapy is frequently advocated for the treatment of musculoskeletal pain and injury of the lower limb. The clinical efficacy, mechanical effects, and underlying mechanism of the action of foot orthotics has not been conclusively determined making it difficult for practitioners to agree on a reliable and valid clinical approach to their application and indeed even their fabrication. This problem is compounded by evidence suggesting that the most commonly used approach for orthotic prescription, the (Biomechanical Evaluation of the Foot. Vol. 1. Clinical Biomechanics Corporation, Los Angeles, 1971) approach, has poor validity and many of the associated clinical measurements of that approach lack adequate levels of reliability. This paper proposes a new approach that is based on two key elements. One is the identification, verification and quantification of physical tasks that serve as client specific outcome measures. The second is the application of specific physical manipulations during the performance of these physical tasks. The physical manipulations are selected on the basis of motion dysfunction and their immediate effects on the client specific outcome measures serve as the basis to making an informed decision on the propriety of using orthotics in individual clients. The motion dysfunction also guides the type of orthotic that is applied. Practical case examples as well as generic and specific guidelines to the application of this clinical assessment process and orthotics are provided in this paper. r 2004 Published by Elsevier Ltd.
1. Introduction mechanical alignment of the foot and lower limbis required normal function. The clinical corollary of this Musculoskeletal pain and injury is a negative con- concept is that the mechanical approach can be used sequence of participating in physical activities, such as as a basis to prevent or treat musculoskeletal injuries. walking and running, that are frequently prescribed and Interestingly, recent laboratory evidence questions the recommended to aid in preventing or overcoming the ability of orthotics to systematically alter mechanical diseases of increasingly sedentary lifestyles. Abnormal alignment of the rearfoot (Heiderscheit et al., 2001; lower limbbiomechanics are often associated with lower Nigg et al., 1999; Stacoff et al., 2000), which seriously limbmusculoskeletal conditions ( James et al., 1978; challenges the validity of the Root et al. (1971) Tiberio, 1987, 1988) and the use of orthotics is paradigm. frequently advocated in their treatment (Sobel et al., McPoil and Hunt (1995) reviewed the available 1999). A popular clinical approach to the prescription literature pertaining to the Root et al. (1971) scheme and fabrication of orthotics is based on the Root et al. of evaluating and treating foot disorders. They identified (1971) paradigm (McPoil and Hunt, 1995; Lang et al., serious concerns regarding the ongoing clinical applica- 1997; Landorf et al., 2001), which in essence is a tion of this traditional means of prescribing orthotics. mechanical approach based on the premise that correct Notably, McPoil and Hunt (1995) reported that several underlying suppositions were not reliable or valid. For ÃTel.: +61-7-3365-2781; fax: +61-7-3365-2275. example, the notion that the subtalar joint neutral E-mail address: [email protected] (B. Vicenzino). position is the position of the rearfoot during mid-stance
1356-689X/$ - see front matter r 2004 Published by Elsevier Ltd. doi:10.1016/j.math.2004.08.003 ARTICLE IN PRESS 186 B. Vicenzino / Manual Therapy 9 (2004) 185–196
(Root et al., 1971, 1977) was not evident when evaluated for any lower limbmusculoskeletal disorder for which in a gait laboratory (McPoil and Cornwall, 1994). In there is a putative biomechanical aetiological basis. It is addition, the physical measurements recommended by adjunctive and complimentary to the ‘tissue-stress Root et al. (1977) to evaluate the foot structure and model’ of McPoil and Hunt (1995), in that it is an function were found to be unreliable and hence of little additional physical examination procedure. This Mas- utility to the clinician (McPoil and Hunt, 1995). In terclass outlines the TDT by describing it in detail and response to this mounting evidence against the Root et presenting case studies that provide practitioners with al. (1971) schema for assessment and treatment of foot exemplars from which to develop and apply the disorders, McPoil and Hunt (1995) proposed an approach in their clinics. alternative model for evaluating and managing foot and ankle problems, which they termed the ‘tissue-stress model’. In utilizing this ‘tissue-stress model’ in the assessment and management of foot and ankle pro- 2. Treatment direction test for foot orthotic therapy: blems, they suggested that the objective of the clinical generic overview examination was to identify symptomatic tissues that were undergoing excessive stress and then, in a The TDT consists of a number of iterations of complimentary manner, to include strategies to alleviate physical activity performed by the client as well as this stress in the treatment program. The inclusion of physical manipulations performed on the client by the strategies to alleviate the stress in the identified tissues practitioner. The express aim is to determine the would be in addition to the conventional physical suitability of orthotic devices in the management of therapy modalities of exercise to treat impaired muscles the lower limbmusculoskeletal condition ( Fig. 1). The and electrophysical agents to reduce inflammation and central feature of the TDT is the identification of pain. The strategies that are usually used to reduce stress physical activities or tasks with which the client has in symptomatic tissues in the lower limbare external difficulties, particularly tasks that provoke pain and physical devices such as orthotics, strapping tape and discomfort. Identification of these tasks occurs in the braces. A recent survey of podiatrists, a profession that is widely associated with the prescription of foot orthotics, has shown that despite the evidence reported by McPoil and Hunt (1995), the majority of podiatrists still utilize the Root et al. (1971, 1977) schema when prescribing orthotics (Landorf et al., 2001). The recent survey of Landorf et al. (2001) indicates that the ‘tissue-stress model’ has not been widely adopted in clinical practice. Indeed, a 1997 Masterclass on the static biomechanical evaluation of the foot referred to the Root et al. (1971) scheme as the basis of the physical examination (Lang et al., 1997). One possible reason for this apparently low uptake of the ‘tissue-stress model’ is that it may not have provided the practitioner with a conveniently pragmatic approach to the prescription and application of foot Fig. 1. Flowchart overview of the treatment direction test (TDT) orthotics that may be viewed as superior to that concept designed to enhance the decision making process in orthotic proposed by Root et al. (1971, 1977). Furthermore, therapy. Note that the key elements are the Client Specific Outcome Measure and the application of a Physical Manipulation. The Client orthotics often impose an additional significant financial Specific Outcome Measure is usually a physical task that exacerbates burden onto the client. If for no other reason, it would the symptoms and is responsible for the client seeking help from the seem that there is a need for a practical and simple health care professional. The practitioner assesses both the quality of approach to the prescription of orthotics by which both motion and the quantity of motion to the first onset of symptoms. the practitioner and client can readily make an informed Then by selecting and applying Physical Manipulations (e.g. tape, felt padding), which is specific to the observed motion impairment, the decision on their application. practitioner makes a decision on the basis of this flow chart. Note that A practical, simple yet seemingly effective approach to be improved by 75% means that the change from baseline is 75% that we have employed in clinic, termed the treatment larger than the baseline measure. For example, if on first assessing the direction test (TDT), seeks to overcome the impasse that Client Specific Outcome Measure the client could jog for 50 m to first was highlighted in the preceding section. In brief, the onset of pain, for a positive TDT then the client would have to jog for 87.5 m (i.e. 50+(75% of 50)) with the specific Physical Manipulation in TDT is part of the physical examination that addresses situ. In practice, the Client Specific Outcome Measure is usually either specifically the propriety of prescribing and applying markedly improved with the Physical Manipulation applied (i.e. no orthotics not only for foot and ankle problems, but also pain with 1000 m jogging) or not. ARTICLE IN PRESS B. Vicenzino / Manual Therapy 9 (2004) 185–196 187 interview and then verification that the physical activity 3. Treatment direction test for foot orthotic therapy: reproduces symptoms occurs in the physical examina- specific application tion, in most cases at the outset of the physical examination. Following verification that the physical In dealing with the specific application of the TDT, activity is provocative of the client’s symptoms, it is the following sections will deal with the assessment of essential that the practitioner quantifies the amount of patterns of foot motion during gait. The identification of physical activity that is required to bring about the first some commonly seen aberrant foot motion patterns and onset of pain (i.e. a pain threshold test). While doing several physical manipulations specific to these aberrant this, the practitioner also observes the motion of the motion patterns will be outlined. Guidelines for orthotic foot during the physical activity to identify any prescription and application, as well as a description of aberration from normal or ideal motion patterns. In several case studies that will highlight various aspects of the event that there are aberrant motion patterns, the the practical application of the TDT will be presented. practitioner then applies specific physical manipulations, which are based on the observed aberrant motions. The 3.1. Assessing quality and quantity of the client specific foot is, the area of the lower limbto which the TDT will physical activity be applied in this Masterclass (noting that TDT concept can be applied to all motion segments of the lower limb). To demonstrate a specific application of the TDT, this The physical manipulations usually take the form of paper will restrict the physical activity to a walking task. adhesive strapping tape or temporary felt orthotics. Quantification of the load to pain threshold could then Then, with the physical manipulations in situ, the client be distance walked, number of steps taken and/or time is asked to perform the specific pain-provoking physical taken to the first onset of pain. Thus quantification of activities that were previously identified and verified. the task to pain threshold is reasonably simple. The The TDT is deemed to be positive if there is an identification of aberrant foot motion during gait is improvement in the motion pattern and more impor- somewhat more difficult and requires a developed tantly if there is a substantial increase of the quantity of observational skill, and if possible, the assistance of a physical activity to the first onset of pain (Fig. 1). A digital video camera by which the motion may be positive TDT implies that there will be a positive captured and then observed within a slower timeframe. outcome to orthotic therapy. If there is no change in the In cases of lower limbmusculoskeletal pain in which amount of physical activity taken to first bring on the abnormal pronation has been suggested as a causative pain with the physical manipulation in place, then the factor (Sobel et al., 1999), it is important to observe gait TDT is deemed to be negative, meaning that an orthotic for any deviation from the ideal pattern of motion. A is not likely to be successful in this instance. In a textbook on gait analysis such as that of Perry (1993) is practical sense, anecdotal evidence suggests that the of considerable help when developing higher-level likelihood of success with subsequent application of an observational skills of motion during gait. orthotic is most probably greatest if the improvement in The use of movement diagrams (e.g. Figs. 2–5), in the quantity of physical activity is in the order of 75% of which the x-axis represents time expressed as a propor- baseline or higher (i.e. substantial improvements). tion of the total gait cycle and the y-axis represents Certainly it would appear logical that if there was only motion, is of considerable value in communicating about a 50% change from baseline level (or lower) concepts regarding the identification of aberrant mo- during the application of the physical manipulation in tions. An ideal pattern of motion of the foot during the TDT it would be likely that there will be a lower stance phase is shown in a movement diagram in Fig. 2, level of success with any subsequent application of in which the foot strikes the floor on the posterolateral orthotics. heel region in a relative neutral position before
Fig. 2. Movement diagram for the ideal rearfoot motion pattern in the frontal plane (supination-pronation movement of the calcaneum relative to the leg shown on the y-axis representing inversion–eversion, respectively) across time (x-axis, showing temporal characteristics displayed as a percent of total cycle). Adapted from Wright DG, Desai SM, Henderson WH. Action of the subtalar and ankle-joint complex during the stance phase of walking. Journal of Bone and Joint Surgery 1964;46A:361–82. ARTICLE IN PRESS 188 B. Vicenzino / Manual Therapy 9 (2004) 185–196
Fig. 3. Movement diagram example of an excessive pronator (continuous line) demonstrating differences from the ideal gait motion pattern of the rearfoot (dotted line). Diagram A shows an ideal contact posture with an initial excessive amount of pronation whereas diagram B shows excessive pronation at contact.
Fig. 4. An example of a supinator pattern of foot motion (continuous line) demonstrating contact in a supinated position followed by a small quick increase in supination soon after. Pronation occurs somewhere later in stance phase and is small and quick. Notice the distinct contrast to the ideal foot motion pattern (dotted line).
Fig. 5. An example movement diagram of a prolonged pronation motion pattern (continuous line) in which the early stages of stance phase are normal but there is no re-supination during mid-stance. Dotted line is ideal pattern. undergoing rapid pronation of approximately 3–51 in also the timing of pronation (early, late). A commonly the first 5–10% of the gait cycle (Perry, 1993). The foot described abnormality of pronation is excessive prona- then remains in this position for another 5–10% of the tion, so labelled because the rearfoot undergoes an gait cycle before re-supinating towards the middle and increased range of pronation during the first part of the end of stance phase. stance phase, notably at contact and weight acceptance For lower limbmusculoskeletal conditions with a (Fig. 3). This may or may not be preceded by pronation putative genesis in abnormal foot pronation, the occurring in terminal swing phase usually observed as identification of non-ideal gait patterns involves ob- floor contact on the medial aspect of the heel. servation of the stance phase of gait for both the Another, not so widely described pattern of abnormal quantity of pronation (excessive or lack thereof) and pronation is one in which there is not only a lack of ARTICLE IN PRESS B. Vicenzino / Manual Therapy 9 (2004) 185–196 189 pronation but also a markedly different pattern of may be uncomfortable to have the reverse sixes and motion during stance phase. This foot motion pattern calcaneal slings passing plantar to the sole of the foot. during gait is termed a supinator pattern (Fig. 4). This Full details of this taping technique including indica- pattern involves a slight but rapid supination (inversion) tions, contra-indications, research findings summaries as its first movement on ground contact and loading and some possible technical variations are shown in such that at foot flat, the rearfoot is relatively inverted to Table 1. the distal leg and also usually to the floor. This position The temporary orthotic, constructed of orthopaedic remains for much of the early part of mid-stance. In felt or foam, is performed when the taping technique has those who have some flexibility in their foot, the foot been shown to relieve pain and improve function. This then undergoes a rapid and small amount of pronation next stage in the decision making process for orthotic in the last part of stance phase, usually at around heel prescription is to evaluate the effectiveness of an in-shoe off. The reader will recognize that this is almost opposite orthotic device to ascertain if it is as effective as the tape. to the ideal gait pattern described above and normal See Table 2 and Fig. 7 for complete descriptions of the patterns reported from kinematic studies. temporary orthotic. In the event that an orthotic, which The previously described motion patterns involve usually incurs a significant financial burden on the both the initial contact and loading part of stance phase client’s behalf, is required in the physiotherapy manage- as well as mid-stance through to terminal stance phases ment of a musculoskeletal condition, it is advantageous of gait. There is also a motion aberration that occurs in to first have demonstrated to the client’s satisfaction mid-stance through to terminal stance, known as that an in-shoe device will in practice have the same prolonged pronation or mid-stance pronation. In this effect as that of the anti-pronation taping technique. gait pattern the foot motion in contact and loading This in-shoe device is usually constructed of a relatively phases were as for the ideal pattern, but instead of inexpensive orthopaedic felt material, which is easy to undergoing re-supination the foot remains pronated in customize to the individual. As shown in Fig. 7 the mid- to late-stance phase of gait (Fig. 5). This pattern of orthopaedic felt is attached to the innersole of the shoe. motion is not to be confused with that which occurs in Key technical points of application of the temporary mid- to late-stance phase of gait in the excessive orthotic are that the distal end of the medial padding pronator or supinator patterns of motion, in which should end 5–8 mm proximal to the metatarsal phalan- there will also be a degree of pronated posture observed. geal joint line. All edges of the padding should be bevelled for comfort and the ‘D-shaped’ sustentaculum- 3.2. TDT for excessive pronator motion patterns tali-navicular support pad should commence just proximal to the level of the medial malleolus and extend There are two basic types of physical manipulations well past the navicular. It should not be placed in the for TDT of excessive pronators, one involving adhesive arch, as this is not an effective location to control strapping tape (Hadley et al., 1999; Vicenzino et al., pronation. A laboratory study has demonstrated that an 1997, 2000) and the other utilizing orthopaedic felt anti-pronation temporary in-shoe device was capable of (Hadley et al., 1999; Vicenzino et al., 2000). The similar mechanical effects, as measured by changes in adhesive strapping tape technique consists of a number vertical navicular height, to that of the augmented low of distinct taping techniques that are frequently dye taping technique described above (Vicenzino et al., combined. The most comprehensive form of adhesive 2000). strapping tape technique is the augmented low dye, There is another circumstance in which the temporary which consists of a modified low dye technique felt orthotics may be used and that is when the taping strengthened by addition of reverse sixes and calcaneal technique produces discomfort or pain at its point of slings (Fig. 6 and Table 1). In brief, the augmented low contact with the skin. For example, it is not uncommon dye is used when there is a requirement to control for a person who has limited dorsiflexion or a marked vertical navicular height (i.e. medial longitudinal arch forefoot varus to experience pain at the skin–tape height), an indirect but reliable and valid measure of interface on the anterior shin region where the reverse pronation (Williams and McClay, 2000), during activ- sixes and the calcaneal slings anchor. ities such as jogging for longer than 10 min (Vicenzino et al., 1997). Usually this is restricted to a TDT in the field 3.3. Anti-pronation orthotic application guidelines in which the practitioner has been unable to find an activity that brings on the pain in the clinic (see Table 1: In the excessive pronator foot motion type, it is usual Variations). It is common practice to use as the physical practice to use orthotics that are somewhat inverted (i.e. manipulation in the clinic, the minimum amount of the angle of the superior surface that contacts the tape, such as, 3 reverse sixes or 2 calcaneal slings. Low plantar foot surface to the inferior surface of the dye taping may be used where there is localized foot orthotic that sits on the shoe), often referred to as being pain, particularly in the arch and heel region where it varus wedged or posted on the medial side of the device. ARTICLE IN PRESS 190 B. Vicenzino / Manual Therapy 9 (2004) 185–196
Fig. 6. Sequential images of the augmented low-Dye tape for excessive or prolonged pronator patterns of foot motion, See Table 1 for further detail; (A) Spur tape commences on the medial forefoot proximal to the metatarsophalangeal joint line, wraps around the heel and finishes on the lateral side of the forefoot. This is the first part of the low-Dye technique. (B) Spur and 3 mini-stirrups. The mini-stirrups arise from the lateral side of the spur and end up on the medial side, with each individual mini-stirrup being laid down in a distal to proximal fashion. Usually 4–6 mini-stirrups are required to extend coverage in a distal to proximal manner, to approximately the region of the sustentaculum tali (not shown here). (C) Completed low-Dye taping technique consisting of a spur, 5 mini stirrups and a locking off spur. If an anchor across the forefoot dorsal surface is required, make sure that this is applied in weight bearing. (D) Reverse sixes (2) which start at about the medial malleolus or proximal to it (not distal to it) that courses over the anterior ankle, distally down the lateral foot, under the plantar mid-foot and wrapping up under the region between sustentaculum tali and navicular before being laid down on the distal leg to anchor onto the anchor strip located some one third to one quarter the way up the leg. (E) Calcaneal sling commences on the anterior leg at the level of the anchor strip, then courses obliquely distally and across the Achilles tendon and heel region, wrapping under the plantar heel and mid foot regions to then pass up by the sustentaculum tali-navicular regions to anchor off at or close to its origin much like the end part of a reverse six. (F) Augmented low-Dye taping technique consisting of a low-Dye, three (3) reverse sixes and two (2) calcaneal slings.
An example of a pre-fabricated type of an anti- level of comfort and then, once comfortable, the pronation orthotic is the three-quarter length shown in orthotics should be tested in a similar fashion to the Fig. 8. Pre-fabricated anti-pronation orthotics usually TDT explained above. All modifications, whether have some degree of varus posting built into the device heating or adding external posts to the device, should (e.g. 2–6 degrees) that can be modified by heating (lessen be guided by this principle and if it is impossible to make the amount of inversion) or the addition of external the device comfortable and ameliorate pain and rearfoot and forefoot postings (to increase the inversion dysfunction, then the client should not be prescribed in the device). The current best level of evidence, which the orthotic. There are several standard issues to is largely based on laboratory work and not on clinical consider in improving the comfort of the device, such trials evaluating the efficacy of these types of devices, as correct sizing (e.g. leading edge ends 5–8 mm indicates that it is perhaps the comfort fit of the device proximal to the metatarsophalangeal joint line, lateral and the improvement in performance rather than the border edge) and excessive pressure in the arch areas of effect on the motion that should guide the fitting of the the orthotic. The latter is usually remedied by either heat devices (Nigg et al., 1999). Thus, when fitting pre- moulding the device and/or by the addition of rearfoot fabricated orthotics (or custom made orthotics) the varus or forefoot varus wedges. Once the orthotic is practitioner should first fit the orthotic to an acceptable comfortable then the TDT approach of re-evaluating ARTICLE IN PRESS B. Vicenzino / Manual Therapy 9 (2004) 185–196 191
Table 1 Anti-pronation taping technique. The augmented low dye technique that may be used as a physical manipulation in the Treatment Direction Test. See Fig. 6 for images of tape
Indication: Pain and dysfunction that exists in a client with an abnormal pronation, either excessive or prolonged. Purpose and Intent: To determine if a transient correction of abnormal pronation is associated with a marked amelioration of symptoms and function. Positioning: Client Supine with distal half of lower limbextending off end of treatment table. Foot Moderately supinated at the rearfoot with neutral forefoot–rearfoot alignment. The client actively holds this Position. Therapist Standing at end of foot with head and torso overhanging the foot. Taping Techniques and Application Guidelines: Material: Rigid adhesive strapping tape 38 mm in width will suit most feet sizes. Low Dye: 1. Spur: commences on the medial side of the forefoot just proximal to the metatarsal phalangeal joint line, while maintaining the rearfoot and forefoot position in the frontal plane, the therapist exerts a slight amount of adduction of the forefoot and plantar flexion of the first ray while laying the tape down on the medial side of the foot and around the heel. The spur then concludes by being laid down on the lateral side of the foot, finishing proximal to the metatarsal phalangeal joint. 2. Mini-stirrups: commence on the lateral side of the foot over the spur and course underneath the foot, being careful not to wrinkle the plantar skin, before finishing on the medial side of the foot at the level of the spur. The last portion of the mini-stirrup is laid down while the therapist applies an inversion force to the medial side of the foot with the hand that is not holding the tape. The exception to this is the first mini-stirrup, during which the therapist plantar flexes the first ray. A series of some 4–6 mini-stirrups are applied, commencing distally at a level just proximal to the metatarsal phalangeal joints and moving more proximally with successive stirrups overlapping each previous one by about a half tape width. 3. Spur lock off: this tape is exactly like the first one but is used to lock in the ends of the mini-stirrups. Reverse sixes 4. Anchor strip applied obliquely to a point on the leg approximately one quarter to one third the way proximal to the ankle. 5. Reverse six: starts at the medial malleolus or proximal to it (not distal to it) and runs across the front of the ankle distal to the lateral midfoot, under the plantar aspect of the midfoot before coursing up the medial side of foot, ankle and leg to anchor on the anchor strip. It is important to have the final part of the reverse six cover the navicular and sustentaculum tali areas of the mid and rearfoot. Calcaneal sling 6. Commences on the anterior aspect of the distal leg at the level of the anchor strip, courses distally and posteriorly to wrap obliquely about the Achilles tendon and heel before wrapping underneath the foot (plantarlly). Lock off tape 7. 3–4 lock of tapes that are exactly the same as the anchor strip but overlay each other by approximately half extend from the anchor strip distally.
Comment: Technical issues—It is very important that the position of the foot and ankle is initially obtained and more importantly maintained during the taping technique as failure to do so often results in an inefficient attempt at correcting pronation during gait. Ensure that the forefoot is not abducted but rather slightly adducted throughout the taping technique. We have shown in a number of studies that this taping technique is superior to others in its effects on arch height, not only immediately after application but also after jogging for 20 min. Risk of either allergic reactions to the tape, or excessive skin stress usually as a result of excessive traction, or compression or injury to underlying soft tissues due to excessive compression must be considered during and after the application of the tape, especially if the taping technique is to be in situ for a protracted period of time. Always follow contour of underlying body part and soft tissues such that there is even pressure visible under both sides of the tape (widthwise) as failure to do so increase the risk of compression injury to underlying tissues. Do not place excessive traction on the tape during its application as this will result in traction stress and possibly injury to the skin.
Variations: In some instances, notwithstanding the data in the literature, it appears advantageous to only apply some components of this technique in order to obtain optimal outcomes. For example, is not at all uncommon to use solely reverse sixes or calcaneal slings or low-Dye taping to achieve the desired pain relieving effects. If the client is unable to nominate a physical activity that can be reasonably measured in the clinic (e.g., in a runner who runs for 20 min to pain onset), then the anti-pronation taping will need to be applied before the client goes for a run.
Contra-indications: Allergic reaction to tape. Increased pain with tape in situ ARTICLE IN PRESS 192 B. Vicenzino / Manual Therapy 9 (2004) 185–196
Table 2 Temporary anti-pronation orthotic. See Fig. 7 for illustrations of this technique
Indication: Pain and dysfunction that exists in a client with an abnormal pronation, either excessive or prolonged. Purpose and Intent: To determine if a transient correction of abnormal pronation is associated with a marked amelioration of symptoms and function. Positioning: Client Prone with distal half of lower limbextending off end of treatment table.In Fig. 4 position to allow the following foot position to be assumed. Foot Foot perpendicular to floor surface. Therapist Sitting at end of foot with head and torso overhanging the foot. Materials: Orthopaedic felt with adhesive backing. A thickness of about 5–8 mm seems best to work with. If greater height is needed it can be achieved by layering. Application Guidelines: 8. Medial footpad (Fig. 7A) Approximately measure and cut out a piece of orthopaedic felt length of the foot and approximately one third the width of the foot. Ensure it is oversize. Trim the heel end of the pad to the shape of the posterior heel. Cut a crescent shape recess into the lateral side of the heel end of the pad to accommodate the heel. Trim the length of the pad at its distal end so that it is some 5–8 mm shy of the first metacarpophalangeal joint line. Bevel the lateral side of the pad and the distal end for comfort. Adhere the pad to the innersole of the shoe. Sustentaculum tail–navicular pad (Fig. 7B): Cut a ‘D’ shaped bit of orthopaedic felt out making sure it is long enough to cover the area from the medial malleolus to the cuneiforms and wide enough to cover from the medial side of the foot to the cuboid. At the heel end of the pad, it is necessary to flatten the curved shape of the ‘D’’ to accommodate the heel to ensure comfort. Lay the pad on the innersole on top the medial footpad so that the lateral extent may be determined and then trim accordingly. Make sure that the finished product does not cover the cuboid. Bevel for comfort fir the lateral part of this pad and then adhere it to the innersole over the medial footpad.
Comment: Constructing this temporary orthotic whilst observing and fitting to the clinet’s foot (as opposed to doing it without the clinet in the room) allows for a customised product with less likelihood of adverse effect. Once the padding is adhered to the innersole then place it up against the plantar surface of the foot to check for correct sizing and allowing for any final trimming before initial testing. Test the temporary orthotic during gait to ascertain if it is comfortable, if not make necessary modifications by trimming or adding more padding. Research has shown that this tecnhique has a similar anti-pronation effect to that of the augmented low-Dye taping technique after 20 minutes of jogging (Vicenzino et al. 2000).
Variations: In order to gain better control of excessive pronation it may be necessary to add another medial footpad or a smaller pad on top of the sustentaculum-tali pad. If there is only minor prolonged pronation, then the medial footpad may not be needed.
Contra-indications: Increased pain with padding in situ, either the client’s symptoms or pain induced from direct pressure of the padding. Allergic reactions to felt in the past.
the client specific outcome measure is undertaken. demonstrated the application of a TDT. In that case, Additional, postings may be required at this stage to there was a substantial improvement from 100 m jogging ensure that the effect is at least the same as for the to onset of pain to 1200 m jogging pain free with a single taping and temporary orthotic. application of several reverse sixes. This improvement was replicated on several occasions and was shown to 3.4. Case examples of the excessive pronation TDT mirror the improvements gained following the longer- applied term application of anti-pronation orthotics. This case exemplar was in distinct contrast to an unpublished case Smith et al. (2004) reported a single case of a soccer study of a triathlete who had a phase III medial tibial player with Achilles Tendinopathy in which they stress syndrome of 12 weeks duration (Roy and Irvin, ARTICLE IN PRESS B. Vicenzino / Manual Therapy 9 (2004) 185–196 193
Fig. 8. Some examples of three-quarter length off-the-shelf orthotics that are frequently used for conditions associated with abnormal pronation, which are commercially available to practitioners.
the TDT to predict the effectiveness (or lack thereof) of orthotic therapy, but do not constitute sufficient level of evidence to be generalized to the broader clinical context. Further work is required to study the clinical utility of the TDT. Anterior knee pain of patellofemoral joint origin is another example of a condition that has been reported to be strongly associated with abnormal lower limb mechanics (Williams et al., 2001) and treatment of this condition by the correction of abnormal foot motion Fig. 7. Sequential images of the components of the temporary anti- pronation orthotic. (A) Medial footpad component of the temporary with orthotics has been advocated (Eng and Pierry- anti-pronation orthotic constructed of orthopaedic felt adhered to an nowski, 1993; Gross and Foxworth, 2003; Saxena and innersole. (B) Sustentaculum tali—navicular pad overlaid on to the Haddad, 2003), including the use of off-the-shelf pre- medial footpad to form the temporary anti-pronation orthotic. See fabricated orthotics (Eng and Pierrynowski, 1993; Table 2 for further detail. Sutlive et al., 2004). The ability to predict the outcome following application of orthotics in patellofemoral pain syndrome is an issue that has recently become the focus 1983). During jogging this case exhibited excessive of several research groups (Gross and Foxworth, 2003; pronation and first onset of pain at approximately Sutlive et al., 2004). We recently completed a case study 400 m of jogging (unpublished case report, Bissett L, of a 30-year-old female with chronic anterior knee pain O’Meara T, Vicenzino B, 2001). There was no sub- that highlights the utility of the TDT to predict orthotic stantial change in the distance jogged to the onset of outcomes in patellofemoral pain syndrome. In brief, pain despite a 20% improvement in vertical navicular prior to anti-pronation taping, consisting of three (3) height with both the application of an augmented low- reverse sixes and a low-Dye, the client walked down dye taping technique and pre-fabricated orthotic. That 4 stairs to the first onset of pain, whereas with taping in is, there was no improvement following augmented low- situ the client was able to walk 62 stairs. This substantial dye anti-pronation taping and this was matched by a change in client specific outcome measure of pain and similar lack of efficacy of a follow up period of function was replicated with the subsequent application protracted use of the anti-pronation orthotic. The of an anti-pronation orthotic of a longer (6 week) follow improvement in vertical navicular height is commensu- up period (unpublished data, Shopka B, Yee B, rate to that reported in several studies of the augmented Costanza A, Al-Marooqi Y, Vicenzino B, 2003). That low-dye technique and temporary orthotic (Vicenzino is, the wearing of an in-shoe orthotic device over a et al., 1997, 2000), indicating that the lack of effective- protracted period of time ameliorated the anterior knee ness in influencing jogging distance to pain onset was pain, and most importantly, this success was predicted not due to a lack of mechanical efficacy of the tape or by the application of the TDT in the physical examina- orthotic. These two cases highlight the clinical utility of tion of this client. ARTICLE IN PRESS 194 B. Vicenzino / Manual Therapy 9 (2004) 185–196
4. TDT for supinator motion pattern An example of cases that frequently respond favour- ably to supinator pads are long term or recurrent foot There is one predominant physical manipulation for and ankle pain as a result of severe or recurrent ankle the supinator pattern of foot motion during gait, termed sprains in which there is observed a supinator pattern of the supinator pad. The supinator pad consists of a piece foot motion during gait. An exemplar case was a patient of foam or orthopaedic felt that is applied to the plantar with diffuse mid-foot pain following several ankle sprains surface of the foot such that distally it ends approxi- in a period of approximately 24 months in which the mately 5–8 mm proximal to the metatarsal phalangeal acute phase seemed to settle but resulted in the client joints, and proximally just distal to the cuboid- experiencing disabling pain when walking down stairs metatarsal articulation. Its lateral extent is to the lateral and on uneven or sloped surfaces. Several programs of border of the foot and its medial side covers at least the conventional physiotherapy over the preceding 18 3rd through 5th metatarsals but not the 1st and 2nd months, consisting of sensori-motor re-training (i.e. metatarsals. It is shown in Fig. 9 and details included in ‘proprioceptive’), had limited impact on this pain and Table 3. The orthotic that is frequently used in these dysfunction, despite showing improvement in balance cases, that is, in the event of a positive TDT, is one that tasks. At the initial physiotherapy session, on using the includes the supinator pad in the orthotic. Frequently TDT for supinator gait pattern it was noted that walking the supinator pad made of ethyl vinyl acetate (EVA) is down stairs was pain free, where it had been previously simply attached to an innersole of the client’s shoes. disabling. A simple 41 forefoot supinator pad was Alternatively, the supinator pad may be attached to a fashioned from an off the shelf orthotic addition (Vasyli low density EVA off-the-shelf prefabricated orthotic Forefoot Valgus wedge) and applied to the innersole of with only little or no built-in rearfoot varus posting. the client’s shoe with the result being a long lasting improvement in pain and function. This apparently effective management by a simple orthotic was predicted by the application of a TDT in the physical examination. The TDT provides an advantage over other skeletal alignment approaches to orthotic prescription in that it directly assures the client during the practitioner–client interaction of the propriety of applying an orthotic in this specific situation and also by guiding the practitioner in the management of the client’s problem by providing individualized data to work with from that client.
5. TDT for prolonged pronation motion pattern
The TDT for prolonged pronation is similar to the excessive pronation. However it should be noted that this motion pattern is difficult to differentiate from normal gait and in some cases from mild cases of supinator type motion patterns, requiring the practitioner to first select either the anti-pronation or supinator TDT approach and then if found not to be suitable to swap to the alternative motion dysfunction TDT. Although this does seem to protract the length of the physical examination somewhat, it would leave the client and the practitioner with little doubt about the appropriateness of proceeding with orthotic therapy or not.
6. Integration of orthotic therapy approach into clinical practice
Other findings on physical examination, such as, muscle tightness and weakness (e.g. of the foot, calf, Fig. 9. Physical Manipulation and Orthotic for supinator pattern of foot motion. (A) Supinator pad adhered to the foot as a Physical thigh and hip musculature), and reduced motion of the Manipulation in the Treatment Direction Test. (B) Supinator pad on talocrural, sub-talar and metatarsal-phalangeal joints an innersole as a temporary orthotic. See Table 3 for further detail. should also be addressed once the effect of the orthotic ARTICLE IN PRESS B. Vicenzino / Manual Therapy 9 (2004) 185–196 195
Table 3 Supinator pad
Indication: Pain and dysfunction that exists in a client with a supinator motion pattern of the foot. Purpose and Intent: To determine if a transient correction of abnormal pronation is associated with a marked amelioration of symptoms and function. Positioning: Client Prone with distal half of lower limbextending off end of treatment table.In Fig. 4 position to allow the following foot position to be assumed. Foot Foot perpendicular to floor surface. Therapist Sitting at end of foot with head and torso overhanging the foot. Materials: Orthopaedic felt or foam with adhesive backing. A thickness of about 5 mm seems best to work with. If greater height is needed it can be achieved by layering. Application Guidelines: Cut out a piece of material so that it fits on the lateral plantar surface of the foot, covering the 3rd–5th metatarsals, ending about 5 mm proximal to the metatarsophalangeal joints and commencing about 5 mm distal to the cuboid-metatarsal joint. Taper the proximal end of the pad in towards the cuboid (Fig. 9A), that is, so that the pad does not cover the lateral cuneiform. As a physical manipulation adhere the pad to the skin (Fig. 9A). As an orthotic, the pad is attached to the innersole or two an off-the-shelf orthotic (Fig. 9B).
Comment: It is important to fashion the pad whilst being able to see and feel the foot so that accurate size of the pad is obtained.
Variations: If the effect on motion and symptoms is not satisfactory then modify the length proximally of the pad and/or increase its thickness by laying on another 5 mm layer. Felt has the advantage of allowing fine adjustments through the addition or removal of small layers as the need requires.
Contra-indications: Allergic reaction to felt Increased pain with tape in situ
has been ascertained. It is sometimes the case that full Acknowledgements amelioration of all symptoms occurs only after the selective application of exercises and manual therapy is I would like to acknowledge the contribution to the used in conjunction with orthotic therapy. Clinical Treatment Direction Test concept of many of my examination findings and a clinical reasoning process, colleagues and students and specifically the following that is based on prioritizing physical findings and who have directly helped in aligned research in this field: systematically addressing these findings guide the selec- Professor Thomas McPoil, Ms. Leanne Bisset, Ms. tion of the exercises and manual therapy. Natalie Collins, Ms. Michelle Smith, Ms. Tara O’Meara, Ms. Suzi Brooker, Mr. Bryan Shopka, Ms. Erin Smyth, Mr. Brian Yee, Mr. Adam Costanza, Mr. 7. Conclusion YacobAl-Marooqi.
The TDT is a simple pragmatic and practical clinical approach to solving the dilemma that confronts the References practitioner who manages clients with lower limb Eng JJ, Pierrynowski MR. Evaluation of soft foot orthotics in the musculoskeletal disorders for which there is a putative treatment of patellofemoral pain syndrome. Physical Therapy aetiological basis in abnormal motion patterns of the 1993;73:62–8. foot during gait. It is an adjunctive process to the Gross MT, Foxworth JL. The role of foot orthoses as an intervention physical examination that seeks to guide the practitioner for patellofemoral pain. Journal of Orthopaedic & Sports Physical in deciding if an orthotic is likely to succeed. Im- Therapy 2003;33:661–70. Hadley A, Griffiths S, Griffiths L, Vicenzino B. Antipronation taping portantly, it does not replace but rather complements and temporary orthoses—effects on tibial rotation position after the conventional comprehensive clinical examination exercise. Journal of the American Podiatric Medical Association performed by musculoskeletal physiotherapists. 1999;89:118–23. ARTICLE IN PRESS 196 B. Vicenzino / Manual Therapy 9 (2004) 185–196
Heiderscheit B, Hamill J, Tiberio D. A biomechanical perspective: do Smith M, Brooker S, Vicenzino B, McPoil T. Use of anti-pronation foot orthoses work? British Journal of Sports Medicine 2001;35:4–5. taping to assess suitability of orthotic prescription: case report. James SL, Bates BT, Osternig CR. Injuries to runners. The American Australian Journal of Physiotherapy 2004;50:111–3. Journal of Sports Medicine 1978;6:40–50. Sobel E, Levitz SJ, Caselli MA. Orthoses in the treatment of rearfoot Landorf K, Keenan A-M, Rushworth R. Foot orthosis prescription problems. Journal of the American Podiatric Medical Association habits of Australian and New Zealand Podiatric Physicians. 1999;89:220–33. Journal of the American Podiatric Medical Association Stacoff A, Reinschmidt C, Nigg BM, van den Bogert AJ, Lundberg A, 2001;91:174–83. Denoth J, Stussi E. Effects of foot orthoses on skeletal motion Lang L, Volpe R, Wernick J. Static biomechanical evaluation of the during running. Clinical Biomechanics 2000;15:54–64. foot and lower limb: the podiatrist’s perspective. Manual Therapy Sutlive TG, Mitchell SD, Maxfield SN, McLean CL, Neumann JC, 1997;2:58–66. Swiecki CR, Hall RC, Bare AC, Flynn TW. Identification of McPoil T, Cornwall MW. Relationship between neutral subtalar joint individuals with patellofemoral pain whose symptoms improved position and pattern of rearfoot motion during walking. Foot & after a combined program of foot orthosis use and modified Ankle International 1994;15:141–5. activity: a preliminary investigation. Physical Therapy 2004;84: McPoil TG, Hunt GC. Evaluation and management of foot and ankle 49–61. disorders—present problems and future-directions. Journal of Tiberio D. The effect of excessive subtalar joint pronation on Orthopaedic & Sports Physical Therapy 1995;21:381–8. patellofemoral mechanics a theoretical model. Journal of Ortho- Nigg BM, Nurse MA, Stefanyshyn DJ. Shoe inserts and orthotics for paedic and Sports Physical Therapy 1987;9:160–5. sport and physical activities. Medicine and Science in Sports and Tiberio D. Pathomechanics of structural foot deformities. Physical Exercise 1999;31:S421–8. Therapy 1988;68:1840–9. Perry J. Observational gait analysis. Downey, CA: Los Amigos Vicenzino B, Feilding J, Howard R, Moore R, Smith S. An Research and Educational Institute; 1993. investigation of the anti-pronation effect of two taping methods Root M, Orien W, Weed J. Biomechanical evaluation of the foot, Vol. after application and exercise. Gait & Posture 1997;5:1–5. 1. Los Angeles: Clinical Biomechanics Corporation; 1971. Vicenzino B, Griffiths SR, Griffiths LA, Hadley A. Effect of Root M, Orien W, Weed J. Normal and Abnormal Function of the antipronation tape and temporary orthotic on vertical navicular Foot, Vol. 2. Los Angeles: Clinical Biomechanics Corporation; height before and after exercise. Journal of Orthopaedic & Sports 1977. Physical Therapy 2000;30:333–9. Roy S, Irvin R. Sports Medicine. New Jersey: Prentice-Hall; Williams DS, McClay IS. Measurements used to characterize the foot 1983. and the medial longitudinal arch: reliability and validity. Physical Saxena A, Haddad J. The effect of foot orthoses on patellofemoral Therapy 2000;80:864–71. pain syndrome. Journal of the American Podiatric Medical Williams DS, McClay IS, Hamill J. Arch structure and injury patterns Association 2003;93:264–71. in runners. Clinical Biomechanics 2001;16:341–7.
PART H:
Collins N, Bisset L, McPoil T, Vicenzino B. (2007) Foot orthoses in lower limb overuse conditions: A systematic review and meta-analysis. Foot & Ankle International, 28(3): 396-412. FOOT &ANKLE INTERNATIONAL Copyright © 2007 by the American Orthopaedic Foot & Ankle Society, Inc. DOI: 10.3113/FAI.2007.0396
Foot Orthoses in Lower Limb Overuse Conditions: A Systematic Review and Meta-Analysis
Natalie Collins, B.Phty. (Hons 1)1; Leanne Bisset, B.Phty., M.Phty (Sports and Musculoskeletal)1; Thomas McPoil, P.T., A.T.C., Ph.D2; Bill Vicenzino, B.Phty., Grad. Dip. Sports Phty., M.Sc., Ph.D1
INTRODUCTION In parallel with this is the evolution of health care towards an evidence-based model in which high quality 41 Foot orthoses have long been advocated in the manage- research evidence is promoted in clinical decision making. ment of musculoskeletal overuse conditions of the lower Randomized controlled trials (RCT), widely deemed as the limb.43 As early as 1972, abnormal foot pronation and subse- gold standard in providing high-quality evidence, are only quent overstress on lower limb soft-tissue structures were surpassed by the pooling of several RCT findings in a implicated in running injuries such as chondromalacia of systematic review and meta-analysis, which represents the 2,41 the patella, shin splints, Achilles tendinopathy, heel spurs, highest level in Sackett’s hierarchy. The current literature and lower-limb stress fractures.18,43,46 Anecdotal reports of on the clinical efficacy of foot orthoses is reflective of successful clinical treatment with foot orthoses often were their anecdotal origins, with a predominance of clinical construed to support the theory that foot orthoses control viewpoint and review papers and a lack of experimentally excessive or prolonged foot pronation during the stance based publications. The lack of higher order synthesis of phase of gait, minimizing overstress on soft tissues and alle- clinical trials to date makes it difficult for a practitioner who viating associated symptoms.46 Current definitions of foot wishes to use evidence-based practice in the prescription of orthoses in the clinical guidelines of the American College of foot orthoses. It is, therefore, timely to conduct a systematic Foot and Ankle Orthopedics and Medicine (ACFAOM)3 and review of the current RCT literature, with the aim to evaluate the Australian Podiatry Council (APC)4 reflect this concept, the clinical efficacy and cost effectiveness of foot orthoses making reference to the goal of controlling abnormal foot in the management of individuals with, or at risk for, lower motion with orthoses. However, debate in recent years on limb musculoskeletal overuse conditions. the mechanism underlying the therapeutic effect of foot 28,33 orthoses questions the role of motion control as a primary METHODOLOGY mechanism of action. Nevertheless, orthoses currently are defined as in-shoe devices that are either custom fabricated Literature Search Strategy (i.e. based on a three-dimensional representation of the indi- vidual’s foot) or prefabricated (generically shaped). Prefabri- A comprehensive search strategy devised using guidelines 1 cated kits for orthoses may allow some degree of customiza- provided by the Cochrane Reviewer’s Handbook, was used tion to the individual patient through heat molding or add-on by a single reviewer (NC) to search the following databases: posts. MEDLINE, EMBASE, CINAHL and Pre-CINAHL, Physio- therapy Evidence Database (PEDro), PubMed, Sportdiscus, 1Division of Physiotherapy, School of Health and Rehabilitation Sciences, The Biological Abstracts, Web of Science, Allied Health and University of Queensland, Queensland, Australia Complimentary Medicine Database, and the full Cochrane 2 Department of Physical Therapy, Northern Arizona University, Flagstaff, AZ Library. All publications listed up until the September 28, Corresponding Author: 2005, were considered for inclusion, and no restrictions Bill Vicenzino, B.Phty., Grad. Dip. Sports Phty., M.Sc., Ph.D. were placed on year of publication, status of publication, or Division of Physiotherapy School of Health and Rehabilitation Sciences language. Abstracts, then full-text versions of papers were The University of Queensland retrieved at successive stages for further evaluation. The Brisbane, Queensland 4072 same reviewer hand searched reference lists of papers that Australia Email: [email protected] met the inclusion criteria, as well as systematic reviews on For information on prices and availability of reprints, call 410-494-4994 X226 related topics that were identified by the search strategy. 396 Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 397
Selection Criteria group, respectively; with a RR of 1 signifying a null effect. To be deemed suitable for inclusion in this systematic The SMD was calculated from the mean change score and review, studies identified by the search strategy had to population standard deviation, using methods of Herbert17 to fulfill key criteria. Clinical trials were selected that randomly extract population standard deviations from pre-standard to allocated participants into intervention groups. Foot orthoses, post-standard deviations or 95% CI where available. A SMD as defined above, were required to constitute at least one of greater than or equal to 0.8 was considered to represent of the interventions used in the management of lower-limb a large clinical effect, 0.5 a moderate effect, and 0.2 a weak overuse injuries. Overuse conditions were included on the effect,8 with a positive value favoring foot orthoses over the basis of the ACFAOM guidelines,3 according to which foot comparison intervention. An SMD of 0 represented a null orthoses were rated as being medically indicated or essential, effect. Data pooling was conducted for studies where there useful, or beneficial as an adjunct to other interventions. was similarity of factors such as the type of foot orthoses, Finally, at least one clinically relevant outcome measure was comparator intervention, and timing of outcome measures. required to measure the effect of the intervention over a A sensitivity analysis was conducted to determine if minimum period of 1 week. the score on the modified PEDro scale would influence the findings of this study, as would be anticipated after Quality Assessment the work of Moher et al.30 who showed that studies with Papers identified by the comprehensive search strategy that improved quality scores returned findings of reduced efficacy fulfilled the selection criteria were retrieved for evaluation of treatment. of their methodological quality. Two independent reviewers (NC and LB), who were blinded to authors, affiliations, and RESULTS the publishing journal, rated each paper using a modified 36 version of the PEDro rating scale (Appendix A). The Search Strategy original PEDro scale was based largely on the Delphi The comprehensive search strategy identified 3192 publi- 49 list of Verhagen et al. Three items that were deemed cations for further evaluation (Figure 1). Of these, 22 papers important in other rating scales were added to the 11 existing met the criteria for inclusion in the systematic review, one of PEDro criteria: justification of sample size, use of outcome which reported two separate studies. Included studies fell into measures with known validity and reliability, and reporting two categories: those that investigated prevention of onset 31 of adverse or side effects. Specific standardized guidelines of a lower limb overuse injury (eight studies reported in were provided for each criterion to minimize rater error. A seven publications) and those that looked at treatment of point was only awarded for a specific criterion when it was injuries (15 studies) (Tables 1 and 2). Within these cate- clearly satisfied. Points scored by an article across all 14 gories, divisions were made based on the comparison group, criteria were then summed to give a final quality rating score. that is: foot orthoses versus control or other interventions; or A similar version of this scale has been used recently, with custom versus prefabricated foot orthoses. Of the 23 studies, 6 good inter-rater agreement (κ 0.824). 14 measured up to 3 months followup, seven up to 6 months Final study ratings for each reviewer were collated and followup, and two investigated outcomes up to 12 months. examined for discrepancies. Any disagreement between raters was discussed in a consensus meeting (NC and LB), Methodological Quality and unresolved items taken to a third reviewer (BV) for reso- Modified PEDro scores ranged from two to 11 out of 14 lution. (mean score 5.77). As demonstrated in Table 3, a number of criteria were poorly represented. Those reported by less Data Management and Statistical Analysis than half of the papers were specification of eligibility Inter-rater reliability of the modified PEDro scores was criteria (criteria one), allocation concealment (criteria three), evaluated with the kappa (κ) statistic. blinding (criteria five, six, and seven), intention to treat Synthesis of quantitative data was conducted using Review analysis (criteria nine), justification of sample size (criteria Manager (Version 4.2)38 Data was extracted directly from 12), and reporting of adverse or side effects (criteria 14). papers where available, using data provided by intention-to- Of the modified PEDro ratings given independently by treat analysis when supplied. A formal written request was the two reviewers, initial disagreement occurred in 41 out of made to authors when studies reported insufficient data. 308 items (κ0.73). Consensus was reached on all but five Relative risk (RR) and standardized mean difference items on initial discussion between the two reviewers, which (SMD) with 95% confidence intervals (CI) were used to were all resolved in discussions with the third reviewer (BV). represent the effect size of dichotomous and continuous Inter-rater reliability for individual criteria ranged from weak variables, respectively, for interventions on a random effects (κ0.25) for criterion one to 100% agreement for criteria two model. Based on previous reports,6,45 a RR of greater than and 10. 1.5 or less than 0.7 was set to represent a clinically beneficial There was no significant correlation between the quality effect in favor of either foot orthoses or the comparison rating score and effect sizes of RR (p = 0.60) and SMD 398 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007
Total number of hits: 12228 Medline: 3511 Embase: 842 Cinahl: 1748 PEDro: 86 PubMed: 1538 SportDiscus: 797 Biological Abstracts: 528 Web of Science: 984 Allied and Complimentary Database: 409 Cochrane Library: 1785
Identification of potentially relevant papers via initial screening by title and abstract (where available):
n = 3192
Excluded: n = 2865 Not lower limb overuse condition No foot orthoses used as an intervention Not RCT (single group; clinical, literature review, and case study papers)
Retrieval of full papers for more detailed evaluation: Excluded: n = 305 n = 327 Not lower limb overuse condition No foot orthoses used as an intervention No evidence of RCT when full paper evaluated (i.e. when not evident from title/abstract) Immediate effects/laboratory studies RCTs included in the systematic review: Retrospective studies n = 22
Fig. 1: Flow chart of the process and rationale used in selecting papers for inclusion in the review, using a highly sensitive search strategy. RCT, randomized controlled trial.
(p = 0.10). Thus, all studies were included in the systematic injured compared to noninjured) was consistently used as a review. primary outcome measure.
Prevention Studies All eight studies that investigated the preventative role of foot orthoses used military populations of similar ages that Foot orthoses compared to controls were undergoing basic or regular military training (Table 13,24,29,32 1). Reasonable sample sizes were available for individual Pooled data from four studies that compared foot studies, with cohorts ranging from 47 to 451. Intervention orthoses to a control group provided evidence of a significant periods and timing of final outcome measures were similar and reasonably sized effect in favor of foot orthoses (RR for all studies (8 to 16 weeks), reflecting the standard military 1.49; CI 1.07 to 2.08) (Figure 2). A fifth study by Simkin basic training period. Although other outcome measures were et al.44 for which effect sizes could not be calculated also used (Table 4), incidence of injury (number of participants reported significant results in favor of foot orthoses. Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 399 ) ID = Continued) size ( conclusions study. Study Notes regarding to orthoses group were assigned to 1 ofprefabricated 6 orthoses that they rated highest on a comfort scale. orthoses significantly decreased the incidence of femoral stress fractures in participants with high arches, and metatarsal stress fractures in participants with low arches. (where effect Participants randomized 1.80) 2.08) 8.45) 2.20) (95% CI) injury RR Effect size: incidence of 8 0.23 (0.03 to 16 2.52 (0.75 to (weeks) & followup Intervention ∼ ∼ ID 12 1.43 (0.99 to ID 14 1.58 (1.13 to ID 14 ID Study conclusions: foot ID (years) 28.5 (6.6) participants Mean (SD) age of 69 22 vs vs vs vs vs (63) (22) 103 (45) 152 (152) 152 (152) per group randomized Sample: total 77 (58) 25 (25) 143 (113) 103 (34) 143 (113) (total analyzed) vs vs vs vs 1 2 3 2 Control Orthoses vs Control Control Control Control customised vs. Comparison Custom (casted) Prefabricated Prefabricated Prefabricated Prefabricated Condition problems fractures (metatarsal, tibial, femoral) fractures or injury back pain/injury Lower limb or Prevention studies: summary of rated studies 2001 Larsen, 2002Milgrom, 1985 Lower limb Lower limb stress Simkin, 1989 Lower limb stress Table 1: Foot orthoses vs. Control Esterman, 2005 Lower limb pain Mundermann, 400 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007 ) ID = size Marketmall Shoe conclusions study. Study 3 Notes regarding were pooled for this review (reported no significant difference in incidence of injury). Finestone 2004b were two separate studies reported in a single publication (where effect 2 custom orthoses groups Finestone 2004a and 3.32) 1.46) 1.77) (95% CI) injury RR Effect size: incidence of (weeks) & followup Intervention (years) , authors have only reported statistical significance; SD, standard deviation; RR, relative risk; participants ∼ 18.77 (0.734) 14 1.95 (1.14 to 18.74 (0.72) 14 1.06 (0.78 to 18.91 (1.1) 14 1.25 (0.88 to Mean (SD) age of 05); ID . 0 vs vs vs Military stress orthotics, Langer Biomechanics Group Inc., Deer Park, NY, USA; = 2 p 126 (53) 224 (213) 208 (172) per group randomized Sample: total 260 (126) 227 (204) 215 (180) (total analyzed) vs + Simple vs vs Orthoses flat insoles soft) (semirigid soft) Prefabricated (soft) semirigid) Prefabricated (semirigid) vs. Comparison Custom Custom (casted, Custom (casted, , no significant difference between groups ( ∼ Condition fractures problems (stress fractures, ankle sprains and foot problems) problems (stress fractures, ankle sprains and foot problems) ) Continued ( Australian Orthotics Laboratory International, Kirrance, New South Wales, Australia; Table 1: Foot orthoses vs. Other intervention Finestone, 1999 Lower limb stress Custom foot orthoses vs. PrefabricatedFinestone, foot 2004a orthoses Lower limb ID, inadequate data provided by authors; 1 CI, confidence interval. Repair, Calgary, AB, Canada. Finestone, 2004b Lower limb Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 401 ID) = Continued) ( 05). . 0 < p strengthening and stretches. facscia stretches. significantly greater decrease in VAS with running, squatting & stairs in orthoses group ( Study conclusions: sample too small to draw firm conclusions; both groups showed significant improvements on final outcome measures. — Lower limb — Achilles & plantar — Effect size (95% CI) effect size 11 31 60 . . . 0 0 0 − − − to 1.85) to 0.61) to 0.77) 0.87 ( 0.15 ( 0.09 ( 2.53) 1.75) 9.66) 8 1.20 (0.57 to 8 0.87 (0.43 to & followup perceived analogue health regarding vs # 51 8 3.33 (1.15 to vs ∼ 10.6 (8.2) ID 29.8 (38) 9.85 (9.85) 8 — ID — Study conclusions: # ∼ 47 age of median # vs 51 # vs (22.5) 61.8 (10.3) 14.8 (1.2) 51.25 67 48.5 42.3 (10.3) 21.8 (24.1) 8 — ID — Achilles stretches. 10 vs vs vs vs vs (total (years) duration (95% CI) SMD questionnaire conclusions (9) 10 (10) 18 (18) 46 (39) 10 (10) analyzed) (months) (95% CI) SMD (where per group 10 (10) 15 (15) 11 (9) 42 (34) 10 (10) + + 4 2 + flat No no + lower 1 vs vs vs vs + + + 3 2 vs. total median vs Comparison randomized participants symptom (weeks) effect RR scale status study. Study exercises exercises insoles lower limb exercises orthoses limb exercises silicone insole stretches orthoses stretches Chiropractic adjustments stretches customised custom Prefabricated Soft customised Prefabricated Condition Orthoses Sample: Mean (SD)/ Mean (SD)/ Intervention Patient Visual Foot Notes knee pain pain metatarsalgia Anteromedial Treatment studies: summary of rated studies Ogilvie, 2004 Table 2: Foot orthoses vs. Control Pfeffer, 1999 Plantar fasciitis Custom (casted) Foot orthoses vs. Other intervention Dimou, 2004 Plantar fasciitis Custom Wiener- Eng, 1993 Anterior knee Kelly, 1999 Lesser 402 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007 p ID) 00). Continued) . ( = 0 < p significant differences between groups at final outcome on pain measures; reported slight differences between groups in VAS (no value). defined in paper, but appeared to be ainsole. flat comparison. significantly lower pain scores with custom orthoses ( Participants served as own Study conclusions: Effect size — — — — — — — (95% CI) effect size 67 87 05 01 36 . . . . . 0 0 1 1 1 19 . 18) . − − − − − 0 0 − − 22 ( 42 ( 19 ( 43 ( 77 ( . . . . . to 0.23) to 0.04) to 0.67) to to 0.14) 1.25) to 0.84) 0 0 0 0 0 − − − − − 0.62) 0.94) 2.48) 8 0.15 (0.03 to 8 0.36 (0.14 to 12 — ID — Study conclusions: no 52 1.09 (0.48 to 24 — 12 — 0.70 (0.15 to 12 — 0.32 ( & followup perceived analogue health regarding vs # # 24 ∼ ∼ vs ID ID 13 (7.6) (R) 26.5 (R) 26.5 # (L) 46 (L) 46 20 # 44 ∼ age of median ∼ ∼ # # vs vs # # 49 49 59.33 7.56 12 — 43 (12) 30 (61.4) 49.5 47 (12) 48.5 48.5 58.6 (20.4) ID 2 — — — ‘Ready made insole’ poorly vs vs vs vs vs vs vs vs (total (years) duration (95% CI) SMD questionnaire conclusions 11 (11) 41 (41) 22 (22) 33 (26) 35 (31) 85 (60) analyzed) (months) (95% CI) SMD (where per group 42 (34) 50 (43) 42 (34) 51 (42) 10 (10) 41 (41) 26 (26) 35 (28) 35 (28) 85 (71) + vs local tension stretches stretches stretches local vs. total median vs vs vs + + + vs 5 6 pronation rubber heel silicone heel Comparison randomized participants symptom (weeks) effect RR scale status study. Study vs orthoses vs cup vs pad ready-made insole pad steroid injection viscoelastic heel cups steroid injection NSAIDs night splints Supination orthoses Custom Custom moulded Custom Condition Orthoses Sample: Mean (SD)/ Mean (SD)/ Intervention Patient Visual Foot Notes neuroma metatarsalgia Morton’s Continued) ( 1994 Table 2: Kilmartin, Pfeffer, 1999 Plantar fasciitis Custom Postema, 1998 Primary Kriss, 2003 Heel pain Soft antipronatory Lynch, 1998 Plantar fasciitis Custom Martin, 2001 Plantar fasciitis Custom Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 403 01) . 0 ID) = Continued) ( = p 001). . 0 < p 042). 9312). PPE only . . 0 0 = p p significantly lower in foot orthoses group at 2,weeks 4 ( & 8 in foot pain &foot increase function in ( at end of 4C); weeks not (Group considered inreview. this and stretches. significantly greater improvement in morning heel pain and overall symptom relief with custom foot orthoses ( of Foot Function Index ( reported as a correlation with splint wearing time. significant difference between groups at final outcome. Reported significant decrease Nonresponders crossed over Study conclusions: no 81 83 02 . . . a 0 0 1 30 Effect size . − − − 0 b c d — Lower limb strengthening − 14 ( 33 ( 13 ( . . . to 0.56) (95% CI) effect size 0 0 0 − − 0.39 ( − to 0.54) to 0.36) to 1.09) 17 . 0 − to 1.77) 0.80 ( 1.26) 8— — 4 — ID — Study conclusions: VAS 8 0.75 (0.45 to 12 ID ID — Study conclusions: & followup perceived analogue health regarding # 21.6 10.6 ∼ 5 ∧ vs (40.5) vs (8.2) . 17.9 (17.8) 12 age of median # 51 ∼ vs (22.5) 38.7 (17.2) 59.9 (13.5) 12.4 (19.6) 45 34.4 (7.6) 8.2 (11.4) 12 ID ID — Pain measured as component 29.85 (6.9) ID 10 6 vs vs vs vs vs (total (years) duration (95% CI) SMD questionnaire conclusions (9) 34 (30) 21 (13) (6) analyzed) (months) (95% CI) SMD (where per group 11 (9) 26 (22) 22 (13) 26 (25) 26 (14) vs heel 1 vs vs heel lift 6 (6) night vs. total median vs vs Comparison randomized participants symptom (weeks) effect RR scale status study. Study lower limb exercises orthoses accommodative (cushioning) orthoses pads (generic) resting splint customised Functional foot Prefabricated Custom Condition Orthoses Sample: Mean (SD)/ Mean (SD)/ Intervention Patient Visual Foot Notes syndrome knee pain syndrome of peroneus longus Anteromedial Continued) ( Ogilvie, 2004 Table 2: Rome, 2004 Plantar heel pain Functional foot Turlik, 1999 Heel spur Russell, 2000 Plantar fasciitis Custom Wiener- Saggini, 1996 Myofascial pain 404 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007 ID) = Tuli International 6 Spenco Sports Medicine value). 2 significant differences between groups at final outcome on pain measures; reported greater improvement in VAS with custom orthoses of 0.2/10 (no p AOL; 1 45 to 47 to 45 to . . . Effect size 0 0 0 14 to 37 to 08 to 25 to 25 to 27 to 34 to 17 to 24 to ...... — − − − 0 0 0 0 0 0 0 0 0 a b c d a b c d a b c d 6 months; − − − − − − − − − (95% CI) effect size 03 ( 06 ( 03 ( . . . 0.69) 0.46) 0.77) 0.58) 0.58) 0.56) 0.49) 0.67) 0.60) 0.38) 0.36) 0.39) 0 0 0 0.16 ( 0.17 ( − 0.14 ( 0.08 ( − 0.25 ( 0.18 ( − Bauerfiend, Kennesaw, GA, USA; 5 44 . 0 —0.28( —0.05( —0.34( − to 0.46) 0.01 ( 2.46) 1.70) 1.73) 1.30) 8 0.59 (0.27 to 12 1.24 (0.62 to 26 1.05 (0.64 to 52 0.98 (0.55 to 12 — ID — Study conclusions: no , authors have only reported statistical significance; PPE, patient perceived effect; VAS, visual Hapad, Bethel Park, PA, USA. ∼ 8 & followup perceived analogue health regarding # 05); ID # . Viscoped, Bauerfiend Gmbh, Hampshire, UK; ∼ 0 Participants only included in study if symptom duration # 4 vs = ∧ ∼ 16 # p ID 20 # 48 ∼ age of median # vs # 48.25 (11.8) 11.5 48.5 47.5 (12) General foot health; d vs vs vs (total (years) duration (95% CI) SMD questionnaire conclusions 44 (43) 47 (42) 85 (62) analyzed) (months) (95% CI) SMD (where per group 46 (45) 42 (34) 85 (71) Footwear; c 8 7 Footscience International, Christchurch, New Zealand; stretches , no significant difference between groups ( 7 vs. total median vs vs + ∼ felt insert Langer Blueline, Langer Biomechanic Group, Inc.; Foot function; Comparison randomized participants symptom (weeks) effect RR scale status study. Study formthotic prefabricated arch supports vs 3 b Foot pain; a Condition Orthoses Sample: Mean (SD)/ Mean (SD)/ Intervention Patient Visual Foot Notes Continued) ( analog scale; NSAIDS, nonsteroidalComponents anti-inflammatory of drug; FHSQ: SMD, standard deviation difference; RR, relative risk; CI, confidence intervals. Table 2: Custom foot orthoses vs. PrefabricatedLandorf, foot 2004 orthoses Plantar fasciitis Custom Martin 2001 Plantar fasciitis Custom ID, inadequate data provided by authors; Pfeffer, 1999 Plantar fasciitis Custom Comfort Products, San Marcos, CA, USA; Products, Toronto, Ontario, Canada; Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 405
Foot orthoses compared to other interventions Foot orthoses compared to controls , Finestone et al.14 demonstrated a significant and clini- Pooling of data from two studies35 50 that compared cally beneficial effect of foot orthoses over simple insoles foot orthoses to no orthoses, with all subjects performing (Table 1). exercises, showed no significant effect in favor of either group for PPE (RR 1.01; CI 0.61 to 1.68) or VAS (SMD − . Custom compared to prefabricated foot orthoses 0.38; CI 0 28 to 1.03) (Table 2; Figure 2). Pooled data from two studies within one publication15 Foot orthoses compared to other interventions comparing custom casted foot orthoses to prefabricated foot In the intervention period of up to 3 months, data orthoses showed no significant effect favoring one type over pooling was not conducted because of violation of the the other (RR 1.14; CI 0.90 to 1.44) (Table 1; Figure 2). assumption of homogeneity of the data (Table 2). Two studies compared foot orthoses to a local steroid injection, with Treatment Studies Kriss22 finding a significant moderate effect in favor of the In contrast to the prevention studies, the 15 studies that injection on VAS, but Lynch et al.25 showing no significant evaluated the treatment of lower limb overuse conditions difference in VAS between groups (Table 2). Heel inserts with foot orthoses had greater heterogeneity in comparator were more frequently used as a comparison intervention, interventions and the type and timing of outcome measures with studies reporting conflicting findings. Lynch et al.25 (Table 2). Consequently, pooling of data was only conducted showed a significant moderate effect in favor of foot orthoses, where similar comparison groups were used, and analysis whereas Pfeffer et al.35 found significant small effects in was divided into three time periods: up to and including favor of two different heel inserts on PPE measures, but 3 months; from 3 months up to and including 6 months; no significant differences on VAS. Two other studies42,48 and greater than 6 months. The consistent use of three reported significantly greater improvements in pain measures outcome measures, patient perceived treatment effect (PPE), for foot orthoses than heel inserts, but insufficient data were pain visual analogue scale (VAS) and Foot Health Status provided to calculate effect sizes. Different outcomes also Questionnaire (FHS), enabled calculation and comparison of arose for studies that compared foot orthoses to a cushioning effect sizes and pooling of data for some studies. Table 4 lists or flat insole. Kelly and Winson20 showed a significant other outcome measures used. Studies evaluated the use of effect in favor of foot orthoses on PPE but not VAS, foot orthoses predominantly in plantar heel pain or fasciitis whereas Rome et al.39 showed no significant effect of one (eight studies), but also in anterior knee pain, primary and group over the other on FHS. Both Eng and Pierrynowski11 lesser metatarsalgia, Morton’s neuroma and peroneus longus and Postema et al.37 found foot orthoses to be significantly myofascial pain syndrome. better than flat or ready made insoles on pain measures (p < 0.05) but did not provide sufficient data for effect RR size calculation. Of the two studies that compared foot orthoses to night splints for plantar fasciitis, Martin et al.26 0.5 1 1.5 2 reported slight differences between groups on VAS but Prevention: did not report statistical significance levels, while Russell40 Foot orthoses* vs. Control measured pain as a component of the Foot Function Index Custom vs. Prefabricated (which overall showed no significant difference between groups (p > 0.05)) but did not report separate pain data. A single study comparing foot orthoses directly to a lower Treatment: limb exercise program showed no effect in favor of either Foot orthoses vs. Control intervention on VAS or PPE,50 while another study that used chiropractic foot and ankle manipulations as a comparison Custom vs. Prefabricated provided insufficient data for effect size calculation but reported no significant difference on final measures.10 Foot orthoses* vs. Control One study that evaluated treatment effects at 6 months found no significant effect of foot orthoses or local steroid injection on VAS22 (Table 2). Similarly, PPE and VAS -0.5 0.5 1 0 measures from a single study looking at treatment effects SMD beyond 6 months showed no significant effect between pronation and supination foot orthoses.21 Fig. 2: Pooled results from prevention and treatment studies comparing foot orthoses to control, and custom to prefabricated foot orthoses. Solid Custom compared to prefabricated foot orthoses shapes indicate relative risks (RR); hollow shapes indicate standardized mean differences (SMD). Timing of outcome measures all 0–3 months. Three studies compared custom to prefabricated foot , , ∗ favors orthoses. orthoses up to a 3-month period.23 26 35 Pooling of data for 406 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007
Table 3: Quality ratings using Modified PEDro Scale of reviewed papers (n = 22). Listed in descending order of quality rating (see Appendix A for details of Criteria 1–14)
Study Criteria Score
1 2 3 4 5 6 7 8 9 10 11 12 13 14 (/14) (%) Landorf, 2004 11 (79) Dimou, 2004 9 (64) Wiener-Ogilvie, 2004 9 (64) Esterman, 2005 9 (64) Larsen, 2002 8 (57) Kelly, 1998 8 (57) Kilmartin, 1994 7 (50) Rome, 2004 7 (50) Postema, 1998 7 (50) Turlik, 1999 6 (43) Finestone, 2004* 5 (36) Pfeffer, 1999 5 (36) Saggini, 1996 5 (36) Eng, 1993 4 (29) Lynch, 1998 4 (29) Martin, 2001 4 (29) Milgrom, 1985 4 (29) Kriss, 2003 4 (29) Mundermann, 2001 4 (29) Russell, 2000 3 (21) Finestone, 1999 2 (14) Simkin, 1989 2 (14)
∗ Single publication that used consistent methodologies to report results from two separate populations
PPE from two studies showed no significant effect favoring treatment studies, they used different comparison interven- either custom or prefabricated foot orthoses (RR 0.88; CI tions and inconsistent outcome measures, therefore pooling 0.42 to 1.81) (Figure 2), which also reflected effect sizes of data was not possible. calculated for the two individual studies.23,35 Martin et al.26 Based on intention-to-treat analysis, Larsen et al.24 repor- did not report statistical analysis to support their findings of ted that the number of people to be fitted with foot orthoses greater improvement in VAS in the group receiving custom that are needed to prevent one case of injury was six (95% orthoses, nor did they provide sufficient data for effect size CI 3–59) at a cost of US $122 (95% CI 58 to 1103). Effect calculation. sizes were unable to be calculated; however, the authors did Landorf23 was the only study to measure effect beyond 3 report a nonsignificant relative risk of 0.7 (CI 0.5 to 1.1). months, with PPE and all subsets of the FHS showing no A more extensive cost-effectiveness analysis conducted by significant effect for either type of orthoses at both 6 and 12 Rome et al.39 provided some data for effect size calculation. months. The total mean cost per patient for using prefabricated foot orthoses in the treatment of plantar heel pain was Cost Effectiveness of Foot Orthoses Intervention significantly greater than using a cushioning insole (SMD Only two studies evaluated cost effectiveness of inter- −3.31;CI−4.38 to −2.24), as was the total mean cost to ventions.24,39 As well as representing both prevention and the hospital podiatry department (SMD −3.89;CI−5.07 to Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 407
Table 4: Summary of measures of outcome used in 23 randomized controlled trials of foot orthoses in lower limb overuse conditions. Includes studies that used components of scales
Number of Outcome measures studies
Occurrence of injury Presence of lower limb injury (self-report, P/E, 8 radiograph, scintigraphy) Development of other symptoms 1 Lower limb pain in the previous 24 hours 1 Patient percieved Global/final outcome score; perceived improvement; 6 treatment effect response rate∗ Progression of pain∗ 1 Relief with intervention∗ 1 Symptom relief VAS 1 Patient satisfaction questionnaire∗ 1 Time to start of improvement 1 Pain Pain VAS (daily; during activities; first-step pain) 7 Pain∗ 1 Numeric Pain Rating Scale 101 1 First-step pain∗ 3 Frequency/severity of morning heel pain∗ 1 Change in pain under various specific circumstances 1 Feelings about life with pain∗ 1 Worry about current pain∗ 1 Pain and function Foot Health Status Questionnaire 3 Foot Function Index 2 MACTAR patient specific measure of maximal function 1 Knee Pain Scale 1 Effect of heel pain on leisure/work/exercise∗ 3 General health Short Form 36 2 EuroQol (EQ5D)Questionnaire 1 World Health Organization Quality of Life Questionnaire 1 (WHOQOL) Short Form Activity Hours of activity per week 1 Change in activity 1 Type & amount of exercise per week; walking distance 2 Hours on feet per day 1 Physical measures Gait analysis 3 Surface electromyography (sEMG) 1 Nerve conduction studies 1 Pressure pain threshold 2 Orthoses comfort Orthoses comfort∗ 2 Compliance Compliance with treatment (% wear, daily splint wearing 3 time) Cost effectiveness Cost of treatment 1 Total off-duty days; subjects with ≥ 1 off-duty days due 1 to lower limb problem
P/E, physical examination; VAS, visual analogue scale (100mm); ∗, Likert rating scale; MACTAR, McMaster Toronto Arthritis Patient Preference Questionnaire. 408 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007
−2.70). There was no significant difference in total mean often are regarded to be superior to prefabricated (off-the- cost to other National Health Service (NHS) services per shelf) foot orthoses. A particularly interesting finding from patient between the two groups. Rome et al.39 also reported this review was the lack of any differential efficacy between that, based on mean scores from the EuroQol health status custom and prefabricated foot orthoses, both from pooled questionnaire,12 use of the foot orthoses resulted in a quality- data and individual study data that could not be pooled. adjusted life year gain of 0.0109 compared to the cushioning This finding requires followup evaluation. Importantly, this insert, and an incremental cost per quality-adjusted life year appears to have clinical implications in the management of of $3210. lower limb overuse conditions, suggesting that the more Two studies mentioned costs of materials for different readily available prefabricated foot orthoses are similar in shoe inserts in their discussion of study findings35,40 but did clinical effect to custom fabricated orthoses. While the not relate these to improvements in outcome measures or cost effectiveness was not directly investigated by the consider the total cost of intervention. included studies, the custom fabricated orthoses tend to be more resource-intensive (e.g. equipment, material, technical Adverse effects of foot orthoses intervention expertise). Another consideration is the wearing-in period Only eight of the 22 papers that were included in the often associated with custom foot orthoses and the delay systematic review analyzed or mentioned the occurrence of between fitting and supply particularly when prescriptions adverse events arising from interventions provided. Kilmartin need to be sent off site. In addition, the lack of differences and Wallace21 was the only study to report an actual between custom and prefabricated foot orthoses supports our incidence of adverse events, with no significant difference decision to consider both types of foot orthoses as one group between groups receiving pronation or supination orthoses. in comparisons with control or other interventions. Both Dimou et al.10 and Wiener-Ogilvie and Jones50 reported Using the best current evidence, it would seem appropriate no adverse events with any of the interventions. that clinical guidelines should de-emphasize the difference Overall, the main adverse effect reported was discomfort. between custom and prefabricated foot orthoses in the This was the primary reason for discontinuing use in reports management of overuse conditions. However, this statement by Finestone et al.15 and Esterman and Pilotto13 and was should be tempered with consideration of deficits in the also reported by participants in the study conducted by studies reviewed and the recognition of the need for further Rome et al.39 Twenty-one percent of participants (30 of 143 research in this area. recruits) allocated to receive foot orthoses in a preventative A potential deficiency of this review was that specific role discontinued their use in the first 14 days because of overuse conditions being studied in individual papers were discomfort.29 Other reported adverse effects of foot orthoses generalized, that is, studies were evaluated and pooled across included arch or metatarsal pain,15 shin splints, and slipping a range of overuse conditions. We considered this to be of the orthoses in the boots.13 Comments about adverse a legitimate approach, because the findings from previous effects of cushioning inserts were slightly different in nature. prevention studies have shown that foot orthoses were effec- The silicone insole used in the study by Kelly and Winson20 tive in preventing a range of overuse conditions, regard- was described as being too hot and slippery, while the insole less of lower limb site. In addition, the overuse conditions 39 included have a putative association with abnormal foot func- used by Rome et al. tended to go hard and flat and lose its 5,9,19,27,47 cushioning ability after 4 weeks of wear. tion, usually ascribed to excessive pronation, and it is frequently recommended that foot orthoses be included in their management.7,16,34 Importantly, the ACFAOM DISCUSSION guidelines3 indicate custom foot orthoses to be either ‘medi- cally indicated and essential’ or ‘useful’ in all of the condi- Two distinct bodies of literature were identified by the tions studied in the reviewed papers, with the exception comprehensive search strategy: studies that evaluated foot of Morton’s neuroma and peroneus longus myofascial pain orthoses in a prevention role, and studies investigating foot syndrome. When Morton’s neuroma has been diagnosed, orthoses in the treatment of lower limb overuse conditions. ACFAOM3 have recommended foot orthoses as an adjunct The systematic review and pooling of data support the to treatment. Peroneus longus myofascial pain syndrome use of foot orthoses in preventing lower limb overuse as described by Saggini et al.42 was not discussed in the conditions in military populations. However, caution should ACFAOM guidelines.3 be exercised in making inferences to populations other than As highlighted in the results, there were a number of military personnel undergoing basic or standard training. In criteria from the modified PEDro scale that were reported comparison, there was insufficient evidence to support or by less than half of the included studies. Although this has refute the use of foot orthoses, either custom or prefabricated, implications for the internal and external validity as well as in the treatment of lower limb overuse injuries. overall power of the studies, correlation analyses between Custom foot orthoses, defined in the ACFAOM guidelines3 the modified PEDro score and effect size showed that the as being derived from a three-dimensional model of the foot, deficits in methodological quality did not appear to affect Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 409 the overall outcome of the meta-analysis. This differs from 2. Altman, DG; Schulz, KF; Moher, D; et al.: The revised CONSORT previous studies that have reported that the inclusion of low statement for reporting randomized trials: explanation and elaboration. methodological quality studies in a meta-analysis can bias Ann. Intern. Med. 134:663– 694, 2001. 30 3. American College of Foot and Ankle Orthopedics and Medicine: the interpretation of the intervention’s benefit. Prescription custom foot orthoses practice guidelines, www.acfaom.org, One of the strengths of this systematic review was 2004. the minimization of bias through the use of independent 4. Australian Podiatry Council: Clinical guidelines for orthotic therapy reviewers who were blinded to authors, affiliations, and provided by podiatrists, www.apodc.com.au, 1998. publishing journals. In addition, publication bias was reduced 5. Bennett, PJ: A randomized clinical assessment of foot pronation and its through using a comprehensive search strategy that encom- relationship to patellofemoral syndrome. Aust. Podiatrist 22:6– 9, 1988. 6. Bisset, L; Paungmali, A; Vicenzino, B; Beller, E: A systematic review passed all publication forms, including conference presenta- and meta-analysis of clinical trials on physical interventions for lateral tions and placed emphasis on hand searching of reference epicondylalgia. Br. J. Sports Med. 39:411– 422, 2005. lists. 7. Brukner, P; Khan, K (eds.): Clinical sports medicine,2nd Edition, This systematic review has attempted to fill a gap in Sydney, McGraw-Hill, 2002. the literature with respect to Level I evidence but also 8. Cohen, J (ed.): Statistical power analysis for the behavioral sciences, Edition 2. Lawrence Erlbaum Associates, Hillsdale, N.J., 1988. has identified a number of issues for future research. Not 9. Dahle, LK; Mueller, M; Delitto, A; Diamond, JE: Visual assessment only is more research into the role of foot orthoses in the of foot type and relationship of foot type to lower extremity injury. J. treatment of lower limb overuse conditions required but it Orthop. Sports Phys. Ther. 14:70– 74, 1991. needs to be of higher quality. Overall, greater consensus 10. Dimou, ES; Brantingham, JW; Wood, T: A randomized, controlled is necessary in the literature as to what constitutes foot trial (with blinded observer) of chiropractic manipulation and Achilles orthoses, perhaps with one consistent set of guidelines that stretching vs. orthotics for the treatment of plantar fasciitis. J. Amer. Chiropr. Assoc. 41:32– 42, 2004. is based on current evidence. Based on evidenced published 11. Eng, JJ; Pierrynowski, MR: Evaluation of soft foot orthotics to date, we would propose the following definition for foot in the treatment of patellofemoral pain syndrome. Phys. Ther. orthoses: in-shoe devices shaped to match the plantar surface 73:62– 68, 1993. of the foot and used in the prevention and treatment of 12. EQ-5D. http://gs1.q4matics.com/EuroqolPublishWeb/, 2006. injury, pain, and disability through the optimization of lower 13. Esterman, A; Pilotto, L: Foot shape and its effect on functioning in extremity function. In addition, the methodology of future Royal Australian Air Force recruits. Part 2: Pilot, randomized, controlled trial of orthotics in recruits with flat feet. Mil. Med. 170:629– 633, 2005. RCT research requires more meticulous planning, using the 14. Finestone, A; Giladi, M; Elad, H; et al.: Prevention of stress 31 CONSORT statement as a guideline to direct high-quality fractures using custom biomechanical shoe orthoses. Clin. Orthop. study. Future research should also investigate the long-term 360:182– 190, 1999. efficacy of foot orthoses. 15. Finestone, A; Novack, V; Farfel, A; et al.: A prospective study of the effect of foot orthoses composition and fabrication on comfort and the incidence of overuse injuries. Foot Ankle Int. 25:462– 466, 2004. SUMMARY 16. Garrett, WE; Speer, KP; Kirkendall, DT (ed.): Principles and practice of orthopaedic sports medicine, Lippincott Williams and Wilkins, Philadelphia, 2000. There is evidence from the meta-analysis to support the 17. Herbert, RD: How to estimate treatment effects from reports of clinical use of foot orthoses in the prevention of the first incidence trials. I: Continuous outcomes. Aust. J. Physiother. 46:229– 235, 2000. of lower-limb overuse conditions. The inclusion of orthoses 18. James, SL; Bates, BT; Osternig, LR: Injuries to runners. Am. J. Sports in a treatment program for individuals who already have an Med. 6:40– 50, 1978. overuse condition is difficult to support or refute because of 19. Kaufman, KR; Brodine, SK; Shaffer, RA; Johnson, CW; Cullison, TR: the generally poor research base, which has been highlighted The effect of foot structure and range of motion on musculoskeletal overuse injuries. Am. J. Sports Med. 27:585– 593, 1999. by this systematic review. 20. Kelly, A; Winson, I: Use of ready-made insoles in the treatment of There is evidence from pooled data that there is no lesser metatarsalgia: a prospective randomized controlled trial. Foot difference between the use of custom and prefabricated foot Ankle Int. 19:217– 220, 1998. orthoses, inferring that practitioners may use either in the 21. Kilmartin, TE; Wallace, WA: Effect of pronation and supination prevention and treatment of lower-limb overuse injuries. orthosis on Morton’s neuroma and lower extremity function. Foot Ankle Int. 15:256– 262, 1994. Focal points for future research conducted in this area 22. Kriss, S: Injectable steroids in the management of heel pain. A include longer intervention durations, greater consistency prospective randomised trial. Br. J. Pod. 6:40–42, 2003. with reliable measures, and better consensus in definitions 23. Landorf, KB: Effectiveness of foot orthoses in the treatment of plantar of foot orthoses. fasciitis. University of Western Sydney, Sydney, Australia, 2004. 24. Larsen, K; Weidich, F; Leboeuf-Yde, C: Can custom-made biomechanic shoe orthoses prevent problems in the back and lower REFERENCES extremities? A randomized, controlled intervention trial of 146 military conscripts. J. Manipulative Physiol. Ther. 25:326– 331, 2002. 1. Alderson, P; Green, S; Higgins, JPT: Cochrane reviewer’s handbook 25. Lynch, DM; Goforth, WP; Martin, JE; et al.: Conservative treatment 4.2. Updated December 2003. In: The cochrane library, Issue 1. John of plantar fasciitis. A prospective study. J. Am. Podiatr. Med. Assoc. Wiley & Sons, Chichester, UK, LTD, 2004. 88:375– 380, 1998. 410 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007
26. Martin, JE; Hosch, JC; Goforth, WP; et al.: Mechanical treatment 39. Rome, K; Gray, J; Stewart, F; et al.: Evaluating the clinical of plantar fasciitis. A prospective study. J. Am. Podiatr. Med. Assoc. effectiveness and cost-effectiveness of foot orthoses in the treatment 91:55– 62, 2001. of plantar heel pain: a feasibility study. J. Am. Podiatr. Med. Assoc. 27. Matheson, GO; Clement, DB; McKenzie, DC; et al.: Stress fractures 94:229– 238, 2004. in athletes. A study of 320 cases. Am. J. Sports Med. 15:46– 58, 40. Russell, BE: Comparison of the plantar fasciitis splint versus the night 1987. resting splint in the treatment of plantar fasciitis, Women’s University, 28. McPoil, TG; Hunt, GC: Evaluation and management of foot and ankle Houston, Texas, 1999. disorders: present problems and future directions. J. Orthop. Sports 41. Sackett, DL; Straus, SE; Richardson, WS; Rosenberg, W; Haynes, Phys. Ther. 21:381– 388, 1995. RB (eds.): Evidence-based medicine: how to practice and teach EBM, 29. Milgrom, C; Giladi, M; Kashtan, H; et al.: A prospective study of Churchill Livingstone, New York, 2000. the effect of a shock-absorbing orthotic device on the incidence of stress 42. Saggini, R; Giamberardino, MA; Gatteschi, L; Vecchiet, L: fractures in military recruits. Foot Ankle. 6:101– 104, 1985. Myofascial pain syndrome of the peroneus longus: biomechanical 30. Moher, D; Pham, B; Jones, A; et al.: Does quality of reports of approach. Clin. J. Pain. 12:30– 37, 1996. randomised trials affect estimates of intervention efficacy reported in 43. Schuster, RO: Podiatry and the foot of the athlete. J. Am. Podiatry meta-analyses? Lancet. 352:609– 613, 1998. Assoc. 62:465– 468, 1972. 31. Moher, D; Schulz, KF; Altman, DG: The CONSORT state- 44. Simkin, A; Leichter, I; Giladi, M; Stein, M; Milgrom, C: Combined ment: revised recommendations for improving the quality of effect of foot arch structure and an orthotic device on stress fractures. reports of parallel-group randomized trials. Ann. Intern. Med. Foot Ankle. 10:25– 29, 1989. 134:657– 662, 2001. 45. Smidt, N; Assendelft, WJ; Arola, H; et al.: Effectiveness of 32. Mundermann, A; Stefanyshyn, DJ; Nigg, BM: Relationship between physiotherapy for lateral epicondylitis: a systematic review. Ann. Med. footwear comfort of shoe inserts and anthropometric and sensory 35:51– 62, 2003. factors. Med. Sci. Sports Exerc. 33:1939– 1945, 2001. 46. Subotnick, SI: Orthotic foot control and the overuse syndrome. Phys. 33. Nigg, BM; Nurse, MA; Stefanyshyn, DJ: Shoe inserts and orthotics Sports Med. 3:75–79, 1975. for sport and physical activities. Med. Sci. Sports Exerc. 31:S421- 47. Taunton, JE; Ryan, MB; Clement, DB; McKenzie, DC; Lloyd- 428, 1999. Smith, DR: Plantar fasciitis: a retrospective analysis of 267 cases. Phys. 34. Norris, CM (ed.): Sports injuries: diagnosis and management, Ther. Sport 3:57– 65, 2002. Butterworth Heinemann, Edinburgh, 2004. 48. Turlik, MA; Donatelli, TJ; Veremis, MG: A comparison of shoe 35. Pfeffer, G; Bacchetti, P; Deland, J; et al.: Comparison of custom inserts in relieving mechanical heel pain. Foot 9:84– 87, 1999. and prefabricated orthoses in the initial treatment of proximal plantar 49. Verhagen, AP; de Vet, HC; de Bie, RA; et al.: The Delphi list: fasciitis. Foot Ankle Int. 20:214– 221, 1999. a criteria list for quality assessment of randomized clinical trials for 36. Physiotherapy Evidence Database. www.pedro.fhs.usyd.edu.au, 2004. conducting systematic reviews developed by Delphi consensus. J. Clin. 37. Postema, K; Burm, PE; Zande, ME; Limbeek, J: Primary Epidemiol. 51:1235– 1241, 1998. metatarsalgia: the influence of a custom moulded insole and a rockerbar 50. Wiener-Ogilvie, S; Jones, RB: A randomised trial of exercise therapy on plantar pressure. Prosthet. Orthot. Int. 22:35– 44, 1998. and foot orthoses as treatment for knee pain in primary care. Br. J. Pod. 38. Review Manager (RevMan): www.cc-ims.net/Revman. 7:43– 49, 2004. Foot & Ankle International/Vol. 28, No. 3/March 2007 FOOT ORTHOSES 411
Appendix A: Modified PEDro rating scale
All criteria: points are only awarded when a criterion is clearly satisfied. If on a literal reading of the trial report it is possible that a criterion was not satisfied, a point should not be awarded for that criterion. 1. Eligibility criteria were specified. This criterion is satisfied if the report describes the source of subjects and a list of criteria used to determine who was eligible to participate in the study. 2. Subjects were randomly allocated to groups (in a crossover study, subjects were randomly allocated in order in which treatments were received). A study is considered to have used random allocation if the report states that allocation was random. The precise method of randomization need not be specified. Procedures such as coin-tossing and dice-rolling should be considered random. Quasi-randomization allocation procedures such as allocation by hospital record number or birth date, or alternation, do not satisfy this criterion. 3. Allocation was concealed. Concealed allocation means that the person who determined if a subject was eligible for inclusion in the trial was unaware when the decision was made of to which group the subject would be allocated. A point is awarded for this criteria, even if it is not stated that allocation was concealed when the report states that allocation was by sealed opaque envelopes or that allocation involved contacting the holder of the allocation schedule who was “off-site.” 4. The groups were similar at baseline regarding the most important prognostic indicators. At a minimum, in studies of therapeutic interventions, the report must describe at least one measure of the severity of the condition being treated and at least one (different) key outcome measure at baseline. The rater must be satisfied that the groups’ outcomes would not be expected to differ on the basis of baseline differences in prognostic variables alone by a clinically significant amount. This criterion is satisfied even if only baseline data of study completers are presented. 4, 7–11. Key outcomes are those outcomes which provide the primary measure of effectiveness (or lack of effectiveness) of the therapy. In most studies, more than one variable is used as an outcome measure. 5–7. Blinding means that the person in question (subject, therapist, or assessor) did not know to which group the subject had been allocated. In addition, subjects and therapists are only considered to be “blind” if it could be expected that they would have been unable to distinguish between the treatments applied to different groups. In trials in which key outcomes are self-reported (e.g. visual analogue scale, pain diary), the assessor is considered to be blind if the subject was blind. 5. There was blinding of all subjects. 6. There was blinding of all therapists who administered the therapy. 7. There was blinding of all assessors who measured at least one key outcome. 8. Measures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groups. This criterion is only satisfied if the report explicitly states both the number of subjects initially allocated to groups and the number of subjects from whom key outcome measures were obtained. In trials in which outcomes were measured at several points in time, a key outcome must have been measured in more than 85% of subjects at the time of primary interest. (Continued) 412 COLLINS ET AL. Foot & Ankle International/Vol. 28, No. 3/March 2007
Appendix A: (Continued)
9. All subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome were analyzed by “intention to treat.” An intention to treat analysis means that, where subjects did not receive treatment (or the control condition) as allocated, and when measures of outcome were available, the analysis was performed as if subjects received the treatment (or control condition) to which they were allocated. This criterion is satisfied, even if there is no mention of analysis by intention to treat, if the report explicitly states that all subjects received treatment or control conditions as allocated. 10. The results of between-group statistical comparisons are reported for at least one key outcome. A between-group statistical comparison involves statistical comparison of one group with another. Depending on the design of the study, this may involve comparison of two or more treatments, or comparison of treatment with a control condition. The analysis may be a simple comparison of outcomes measured after the treatment was administered, or a comparison of the change in one group with the change in another (when a factorial analysis of variance has been used to analyze the data, the latter often is reported as a group x time interaction). The comparison may be in the form hypothesis testing (which provides a “p” value, describing the probability that the groups differed only by chance) or in the form of an estimate (for example, the mean or median difference, or a difference in proportions, or number needed to treat, or a relative risk or hazard ratio) and its confidence interval. 11. The study provides both point measures and measures of variability for at least one key outcome. A point measure is a measure of the size of the treatment effect. The treatment effect may be described as a difference in group outcome, or as the outcome in (each of) all groups. Measures of variability include standard deviations, standard errors, confidence intervals, interquartile ranges (or other quartile ranges), and ranges. Point measures or measures of variability may be provided graphically (for example, standard deviations may be given as error bars in a Figure) as long as it is clear what is being graphed (for example, as long as it is clear whether error bars represent standard deviations or standard error). When outcomes are categorical, this criterion is considered to have been met if the number of subjects in each category is given for each group. 12. The sample size is justified. In calculating the sample size, statistical evidence was provided regarding the power of the study and its effect size. 13. The study uses outcome measures that have known validity and reliability. Outcome measures used in the study were referenced for their validity and reliability. If more than one assessor was used for the outcome measures, inter-tester reliability studies were performed, and results of these stated. 14. Adverse or side effects were reported. All adverse events were described and correctly attributed to allocated treatment. If no adverse events occurred, the report explicitly states “no adverse events.” A comparison was made between the beneficial effect of the intervention and the adverse events (i.e. did the benefits of the intervention outweigh the adverse events?).
PART I:
Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: A RCT. BMC Musculoskeletal Disorders 2008, 9:27 doi:10.1186/1471-2474-9-27 BMC Musculoskeletal Disorders BioMed Central
Study protocol Open Access Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: A randomised clinical trial Bill Vicenzino*†1, Natalie Collins†1, Kay Crossley†2, Elaine Beller†3, Ross Darnell†1 and Thomas McPoil†4
Address: 1Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia, 2School of Physiotherapy, The University of Melbourne, Melbourne, Australia, 3Queensland Clinical Trials Centre, School of Population Health, University of Queensland, Brisbane, Australia and 4Gait Research Laboratory, Department of Physical Therapies, Northern Arizona University, Flagstaff, USA Email: Bill Vicenzino* - [email protected]; Natalie Collins - [email protected]; Kay Crossley - [email protected]; Elaine Beller - [email protected]; Ross Darnell - [email protected]; Thomas McPoil - [email protected] * Corresponding author †Equal contributors
Published: 27 February 2008 Received: 4 February 2008 Accepted: 27 February 2008 BMC Musculoskeletal Disorders 2008, 9:27 doi:10.1186/1471-2474-9-27 This article is available from: http://www.biomedcentral.com/1471-2474/9/27 © 2008 Vicenzino et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Background: Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy. Methods/design: A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18–40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries. Discussion: The randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions. Trial registration: Australian Clinical Trials Registry ACTRN012605000463673 ClinicalTrials.gov NCT00118521
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Background In order to provide clinicians with high quality evidence Patellofemoral pain syndrome (PFP) is a distinct clinical upon which to base clinical decision making, it is there- entity defined as "idiopathic pain arising from the ante- fore timely to conduct a RCT to establish the long term rior knee/patellofemoral region that is of otherwise clinical efficacy of foot orthoses in the management of unknown origin" [1]. Falling within the classification of PFP. lower limb musculoskeletal overuse conditions, PFP is highly prevalent among active individuals. A recent retro- Methods spective review of running injuries found PFP to be the Aim most common presentation to a sports medicine clinic in The primary aim of this study is to determine the clinical both females (19.2% of injuries) and males (13.4% of efficacy of foot orthoses in the management of PFP, as injuries) [2]. The pain and disability resulting from this compared to a flat insole, a proven physiotherapy pro- condition not only affects short term participation in gram, and a combined intervention of foot orthoses and daily and physical activities, but can have a significant physiotherapy. The cost-effectiveness of foot orthoses long term impact, with symptoms shown to persist in 1 in compared to the other interventions will also be evalu- 4 sufferers for up to 20 years after initial presentation [3]. ated. As regular physical activity is highly recommended for the prevention of conditions such as cardiovascular disease Study design and type II diabetes, PFP may have important implica- The above aims will be investigated through the conduct tions for the long term health of affected individuals. of a pragmatic randomised single-blinded clinical trial in a community setting over a 12 month period. All partici- Given the prevalence and impact of this condition and the pants will provide written informed consent prior to ran- subsequent demands placed on health care practitioners, domisation. The investigator responsible for taking the the lack of high quality research on the conservative man- outcome measures will be blinded to participants' group agement of PFP is surprising [4,5]. A recent systematic allocation. In order to maintain blinding of this investiga- review by Crossley et al [5] concluded that current man- tor, randomisation will be effected and controlled by an agement of PFP is not based on evidence from ran- independent body, and a research assistant will perform domised controlled trials (RCTs), which are widely all communication regarding group allocation. An over- deemed to be the gold standard of research design in pro- view of the study protocol is provided in Figure 1. viding the best evidence for health care interventions [6]. Ethics Foot orthoses are a commonly used and frequently rec- Ethical approval for this study has been granted by the ommended intervention in the management of PFP [7]. University of Queensland's Medical Research Ethics Com- Preliminary evidence of their clinical efficacy is provided mittee. by findings of a pilot study of 20 adolescent females [8]. The addition of soft foot orthoses to an exercise program Eligibility criteria resulted in significantly greater improvements in pain Volunteers will be eligible for participation in the study than treatment with flat insoles and exercises over eight on the basis of the following criteria: (1) anterior or retro- weeks. A more recent study by Wiener-Ogilvie & Jones [9] patellar knee pain of non-traumatic origin and greater however found no difference in outcome between 8 weeks than six weeks duration that is provoked by at least two of of treatment with functional foot orthoses, exercises, or the following activities: prolonged sitting or kneeling, orthoses with exercises. The authors considered the small squatting, jogging or running, hopping, jumping, or stair sample size (N = 31) to have contributed to the inability ascending/descending; (2) the presence of pain on palpa- to detect a significant difference between the three groups. tion of the patellar facets, on step down from a 25 cm step, Conversely, a popular physiotherapy program used rou- or during a double leg squat; and (3) pain over the previ- tinely in Australia does have high quality RCT evidence to ous week equal to or greater than 30 mm on a 100 mm support its use in PFP. Crossley et al [10] showed this six visual analogue scale. Due to the nature of the outcome week physiotherapy program of quadriceps muscle measures to be used, participants will require an accepta- retraining, patellofemoral joint mobilisation, patellar tap- ble understanding of written and spoken English. An abil- ing and daily home exercises to be significantly superior ity and willingness to attend all sessions required for to sham ultrasound, non-therapeutic gel application and completion of the study and comply with intervention placebo taping. The short follow up period used in all protocols for the 12 month study period will also be an three studies could be considered to be a downfall, partic- essential criterion. Volunteers will be excluded if they ularly given the condition's demonstrated tendency for have any of the following: (1) concomitant injury or chronicity [3]. pathology of other knee structures (e.g. menisci, collateral and cruciate ligaments, patellar tendon, iliotibial band,
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FlowFigure of 1participants through the randomised clinical trial Flow of participants through the randomised clinical trial. pes anserinus); (2) a history of knee surgery, patellofemo- sion; (4) any foot condition that may preclude the use of ral dislocation or sublaxation, Osgood-Schlatter's disease foot orthoses; (5) pain in and/or referred from the hip or or Sinding-Larsen-Johanssen syndrome; (3) a positive lumbar spine; or (6) a known allergy to rigid strapping patellar apprehension test; evidence of knee joint effu- tape. Prior treatment with foot orthoses will also preclude
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volunteers from participating in order to facilitate blind- site body, will be responsible for generating and main- ing as to the differences between the foot orthoses and flat taining the randomisation sequence. A research assistant insoles, as will prior physiotherapy treatment for PFP will perform the communication between the Queens- within 12 months of entry into the study and current use land Clinical Trial Centre, participants and project physi- of anti-inflammatories or corticosteroids. All participants otherapists to prevent unblinding of the blinded assessor. will be required to be a minimum of 18 years of age for consent purposes, and a maximum of 40 years in order to Intervention minimise the likelihood of degenerative joint changes. Interventions will be administered by one of 17 experi- enced registered physiotherapists (Physiotherapists Board Recruitment of study participants of Queensland) located throughout the catchment area. In order to recruit a representative sample of sufficient All project physiotherapists will have attended two semi- size, a multifaceted recruitment strategy that has been suc- nars for explanation and discussion of the intervention cessful in past clinical trials will be used. This will target protocols and training in fitting of foot orthoses. A quali- the greater Brisbane, Gold Coast and Toowoomba regions fied sports physiotherapist who has extensive experience in Queensland, Australia. Paid advertisements in local in the management of PFP with orthotics will conduct and regional newspapers will be placed at regular intervals these seminars. A comprehensive manual outlining study during the recruitment period, along with media releases procedures will be provided to all project physiothera- to broaden the scope to radio and television media. These pists. will be reinforced by regular posting of advertisements on University, gymnasium and community noticeboards Participants will attend six 20–60 minute appointments within the catchment area. It is anticipated that a small over a six week period (i.e. one session per week), with number of referrals will also come from physiotherapists details of each session recorded by the project physiother- involved in the study, as well as general practitioners apist in a treatment log. On completion of the six visits, through the provision of information and advertising participants will continue with a self-management pro- packages. gram for the remainder of the 12 month study period. This will incorporate the home exercise program relevant Volunteers who respond to advertisements will be put to their allocated intervention. through a two-stage screening process to determine their suitability for inclusion in the study. Firstly, a preliminary The four intervention groups are as follows. telephone interview will be conducted to screen for major exclusion criteria. Potential participants will then be 1. Foot orthoses invited to attend an appointment at the University of Participants assigned to this group will be provided with Queensland, where they will be provided with further prefabricated foot orthoses from a commercially available information about the screening process and study. A range (Vasyli International). The orthoses are made of comprehensive musculoskeletal examination will then be ethylene-vinyl acetate (EVA) of high (Shore A 75°), conducted by a qualified physiotherapist to determine the medium (Shore A 60°) or low (Shore A 52°) density, and volunteer's suitability for inclusion based on the eligibil- have an inbuilt arch support and 6° varus wedge as spec- ity criteria. At the completion of the examination, eligible ified by the manufacturer. The range includes four types of volunteers will be provided with an information sheet orthoses to suit a variety of footwear: full length and three- that thoroughly explains the study protocol. They will quarter length (general use); easy fit (a three-quarter then attend a follow-up appointment for completion of length with lateral cut-away for narrower footwear e.g. informed consent documentation and baseline outcome men's dress shoes); and slim fit (a thin minimally arched measures. This will be conducted by an assessor who will orthosis designed for women's dress/court shoes). In remain blind to group allocation and be responsible for order to maximise compliance, orthoses will be fitted to taking outcome measures at designated follow-up times. up to four pairs of the participants' shoes, using a stand- At this appointment, the knee rated to be the most severe ardised iterative procedure based primarily on perceived by participants with bilateral PFP will be selected as the comfort (Figure 2). The first stage will involve selection of knee to be studied. an appropriate device based on the amount of space avail- able in the shoe (Step 1a) and the length of the partici- Randomisation pant's foot (Step 1b). In the first instance, an orthosis Once informed consent has been obtained and baseline made from the highest density EVA will be used (Step 2). outcome measures completed, each participant will be Following this process, if the orthoses are uncomfortable assigned a participant number and randomly allocated to when worn in the shoe, the therapist will review the type, one of four intervention groups via concealed allocation. size and density, and then choose an alternative orthosis The Queensland Clinical Trial Centre, an independent off- that does fit comfortably. If the participant is not satisfied
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FigureSequential 2 procedure for fitting of foot orthoses Sequential procedure for fitting of foot orthoses.
with the comfort level of the orthoses, the orthoses will be 2. Flat inserts customised. This will first involve heat moulding as per This condition will act as a control for the application of the manufacturer's instructions (Step 3a). This process inserts into the footwear, and will likely account for some involves mildly heating the underside of the orthosis, of the potential placebo effects of prescribing an in-shoe placing it in the intended shoe and then having the partic- device. The flat inserts will be identical in initial appear- ipant stand on it with the foot positioned in its neutral ance to the foot orthoses described above, made from the zone for approximately 60 seconds. If the heat moulding same EVA with identical covering fabric and company process alone fails to optimise comfort, the therapist will logo. However, this device will be of uniform thickness sequentially trial the addition of medial wedges of the rear along its length (3 mm) and have no inbuilt arch or varus and forefoot and/or a heel raise to the orthoses (Step 3b). wedging. The only modification that will be made to this The medial rearfoot wedges have a manufacturer specified insert is gentle heat moulding over the six appointments. 2° or 4° of inclination, the forefoot wedges 4° or 6° and Participants will be taught a home exercise program of the heel raises are 4, 6 or 8 mm thick. The forgoing under- minimal balance training, slowly progressing from stand- scores the primary goal of fitting of the orthoses to achieve ing on one leg while holding a rail for support, to unsup- a comfortable fit. Once comfort has been achieved, the ported single leg stance, moving toes up and down, and effect of the orthoses on performance of a functional task with eyes closed. The exercise program will not be rein- will be evaluated. This will involve quantification of the forced as with the other interventions. effect of the orthoses on pain-free performance of an activ- ity identified as pain provocative immediately prior to 3. Physiotherapy orthosis fitting, such as, step ups, step downs or squats. A The physiotherapy program will consist of a combined substantial increase in the number of pain-free repetitions therapy approach that represents the current Australian that can be performed will be regarded as a success. The best practice. A recent RCT showed this program to pro- therapist will modify the orthoses in order to improve the duce a significantly greater reduction in pain and disabil- performance of the functional task, but with the funda- ity over six weeks compared to a placebo intervention mental aim of ensuring the orthoses are comfortable. This [10]. The major components are outlined in Table 1 and process of fitting, reviewing and adjusting the orthoses illustrated in Figures 3 and 4. will continue over the six visits. Participants will also be given a home exercise program of foot arch-forming exer- 4. Foot orthoses and Physiotherapy cises and weight-bearing calf stretches to be performed Participants assigned to this group will receive both the bilaterally twice daily. foot orthoses and physiotherapy programs as described in 1 and 3 above. Due to the large volume of treatment deliv- ered, participants in this group may undergo a seventh
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Table 1: Physiotherapy program (adapted from Crossley et al, 2002).
Intervention Dose
Patellar mobilisation: I. Passive patellar medial glide and tilt combined with transverse friction massage of the lateral retinaculum 4 × 30 seconds
Stretches: I. Hamstring stretches 3 × 20 seconds; bilateral II. 'Figure 4' anterior hip stretch (Figure 3) 3 × 20 seconds; bilateral
Patellar taping: I. Taping of the patella: Daily application for 6 weeks 1. Medial tilt and posterior tilt 2. Medial glide and posterior tilt 3. Fat pad unloading 4. Medial rotation
Exercises: I. Hip external rotation retraining (Figure 4) 3 × 20 seconds; bilateral II. Vasti retraining (with EMG biofeedback): i. Isometric VMO contraction in sitting 3 × 10 repetitions (affected); 1 × 10 repetitions (unaffected) ii. Inner range knee flexion in standing 3 × 10 repetitions iii. Step downs (when able to perform 5 pain-free repetitions): a) Slow eccentric lowering on affected leg from 10 cm step 3 × 10 repetitions b) Increased step height (20 cm step) 3 × 10 repetitions c) Alternating speed (down slow, up fast; down fast, up slow) 3 × 10 repetitions
Home exercise program: I. Self-mobilisation of the affected patella As above; twice daily II. Patellar taping (as above) III. Stretches (as above) IV. Exercises (as above)
visit with the physiotherapist to ensure adequate fit and vating activities particularly if the provoked pain persists comfort of the orthoses and understanding and progres- longer than several minutes after cessation of the activity. sion of the physiotherapy exercise program. Outcome measures All participants will receive an educational package at the The blinded assessor will repeat the outcome measures commencement of the study, providing general informa- following completion of the 6 visits with the physiothera- tion on PFP and advice on activity. In general terms, the pist at 6 weeks, and then at 12 and 52 weeks to assess the advice on activity will entail an encouragement to partici- long term outcome of the intervention. pants to continue to exercise and participate in activities that do not provoke their knee pain, and to avoid aggra- Outcome will be assessed at each time point using meas- ures that have been previously demonstrated as being acceptably reliable and valid indictors of change [11-16] and used in previous high-quality RCTs of PFP [10,17,18]. The primary outcome measures will be as follows.
1. Usual and worst pain Visual Analogue Scale A 100 mm horizontal line with the descriptors 'no pain' at the 0 mm mark and 'worst pain imaginable' anchoring the 100 mm end will be used as a visual analogue scale. Par- ticipants will be required to place a vertical mark that rep- 'FigureFigure 4' 3 anterior hip stretch in prone resents their pain level on the horizontal line. They will do 'Figure 4' anterior hip stretch in prone. this twice, once to indicate their usual level of pain in the preceding week and the other to represent their worst pain
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experienced over the same time period. This will give two perceived pain severity ratings in millimetres [19]. The pain VAS has well-established reliability and validity in individuals with AKP [11,14,15,19].
2. Anterior Knee Pain Scale This scale consists of 13 items with discrete categories related to limp, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting with flexed knees, pain, swelling, painful patellar movements, thigh muscle atrophy, and flexion deficiency. One response to each item that best describes the participant's knee pain is selected and scored on a weighted basis, with the highest representing normal and asymptomatic [20]. The 13 indi- vidual items are then summed to provide a final score where 0 represents maximal disability and 100 represents no disability. This scale has been shown to have high test- retest reliability [15,16], moderate responsiveness to clin- ical change [16], and a demonstrated ability to discrimi- nate between individuals with and without AKP [20].
3. Functional Index Questionnaire The Functional Index Questionnaire comprises eight questions pertaining to whether activities that are com- monly problematic in PFP can be performed with or with- out difficulty [14,19]. The activities, including prolonged sitting, squatting and stair climbing, are each rated on a three point scale, where 0 = unable to do, 1 = can do with problem, and 2 = no problem. The sum of the scores for each of the eight activities provides an overall score, with 0 indicating maximal disability and 16 representing no disability. Studies have shown the FIQ to have fair to sub- stantial test-retest reliability [11,14,15,19], and to be a valid measure for detection of clinical change [14].
4. Patient Perceived Treatment Effect Score and Perceived Global Effect Visual Analogue Scale Participants' perceived level of recovery will be rated on two scales at the 6, 12 and 52 week follow-up visits. Per- ceived Treatment Effect will be measured using a 5 point Likert scale with the following categories: (1) marked worsening, (2) moderate worsening, (3) same, (4) mod- erate improvement, and (5) marked improvement. For the purpose of analysis, this scale will then be dichot- omised according to success, where 'success' is defined as marked or moderate improvement on this scale [10]. We will also conduct a sensitivity analysis on this dichotomi- sation. Perceived Global Effect Visual Analogue Scale will be piloted. Participants will rate their recovery by placing a vertical mark on a 200 mm VAS with 'same' in the mid- dle to represent no change (0 mm), 'much worse' at the far HipFigure external 4 rotation retraining left end (-100 mm) and 'completely better' as the right Hip external rotation retraining. hand anchor (+100 mm). A positive score will represent improvement, while a negative score will indicate worsen- ing of the condition.
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Secondary outcome measures that will be taken include changes with time, and leaves the question blank if there the following: is no pain.
1. Lower Extremity Functional Scale 4. Medical Outcomes Study 36-Item Short-Form Health Survey The Lower Extremity Functional Scale is used to evaluate This questionnaire is a widely-used generic measure of any difficulty experienced during daily activities as a result health-related quality of life [23], and has been previously of the specific lower limb condition, such as PFP, and has used in PFP populations [10]. Thirty-six items are used to been shown to be reliable, valid and sensitive to change in calculate eight multi-item scores: physical functioning, AKP participants [16] and those with general lower limb role limitations due to physical health problems, bodily conditions [12]. Twenty items are rated individually on a pain, general health, vitality (energy/fatigue), social func- 5 point scale indicating the degree of difficulty associated tioning, role limitations due to emotional problems, and with performing that activity on the current day, ranging mental health. from 0 (extreme difficulty or unable to perform the activ- ity) to 4 (no difficulty). Scores from each activity are 5. Hospital Anxiety and Depression Scale summed to give an overall indication of functional diffi- This 14-item scale will be used to investigate whether culty, where 0 indicates maximal difficulty and 80 indi- there is an association between PFP and emotional state, cates no difficulty. and has been found to be a reliable instrument for detec- tion of anxiety and depression in an outpatient setting 2. Patient-Specific Functional Scale and a valid indicator of severity [24], and has been used in The Patient Specific Functional Scale assesses individual a previous study of physiotherapy in PFP [17]. Partici- disabilities in a short, efficient format, and was designed pants are required to select the best of 4 responses to ques- to complement generic or condition-specific measures tions pertaining to either anxiety or depression (7 [13]. It has been shown to have excellent test-retest relia- questions each), which are scored from 0 to 3. The scores bility and sensitivity, and good validity in individuals for the anxiety and depression questions are summed sep- with knee dysfunction [13]. Participants are asked to arately to give total scores for each component, where 0–7 nominate up to 5 functional activities that they are expe- represents no anxiety or depression, 8–10 is borderline, riencing difficulty with. The current level of difficulty asso- and 11–21 indicates the presence of an anxious or depres- ciated with each activity due to the specified condition is sive state. then rated on an 11-point scale, where 0 is "unable to per- form the activity" and 10 is "able to perform activity at 6. Physical Activity Level in the Previous Week same level as before injury or problem", and the average Participants' physical activity levels will be quantified score across all activities is calculated. using a physical activity questionnaire by which occupa- tional, household and leisure activities of varying intensi- 3. McGill Pain Questionnaire ties can be accurately and reliably measured [25]. This The most commonly used multidimensional pain meas- questionnaire involves calculation of the time spent in ure, the McGill Pain Questionnaire provides a description each of these activity types at moderate, hard and very of the participant's pain experience, and has been utilised hard intensities over the preceding 7 days. The total time as a primary outcome measure in previous knee pain stud- in hours for each intensity of activity is then multiplied by ies [21,22]. The first component involves descriptors of the metabolic equivalents of the activities (METs, kcal/kg/ pain categorised as sensory, affective, evaluative and mis- hour), and summed to give an overall caloric output for cellaneous. Twenty groups of words are presented, with the week, and divided by seven to give an average daily the participant required to select one word from each output. This can then be standardised to body weight to group that best describes their pain. The word chosen is provide an index that can be compared between and scored by its rank order within the group, with the first within individuals across time [25]. This questionnaire word scoring 1, the second word scoring 2, and so forth. has been shown to have moderate to high reliability on If no words are applicable a score of zero is recorded for test-retest, especially with moderate and vigorous intensi- that group. The Pain Rating Index is the sum of the scores ties of activity [25], and has been used previously in a PFP across the 20 groups (range 0–78). The Number of Words population [10]. Chosen is the number of groups for which a word was selected (out of 20). The second component is the Present 7. Step up, step down and squat tests Pain Index, a six point scale of severity ranging from no Three activities that typically provoke PFP will be used as pain (0) to excruciating (5). For the final component, the a physical measure of function [10]. Step up and step participant selects one of three groups of words that best down tests will be performed on a 25 cm step in a step- describes the pattern of their knee pain, or how pain ping order that continually loads the study knee, while squats will be of full excursion to the point where the fin-
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gers touch the floor. A metronome set at 96 beats per 15.0) will be used for statistical procedures. The four minute will be used to standardise the rate of testing. The groups will be examined for baseline comparability with repetition number on which the first onset of pain occurs, respect to demographic data such as age, gender, body or the first increase in pain where a constant background mass index and duration of knee pain, as well as baseline ache is present, will be recorded, up to a maximum of 25 values of outcome measures. Continuous outcome meas- repetitions. ures taken at 6, 12 and 52 weeks will be analysed using univariate analysis of variance, where the baseline value of 8. Pressure Pain Threshold (PPT) the outcome measure will be used as a covariate and Pressure algometry, which has demonstrated reliability group allocation as a fixed factor. Continuous data will [26], will be used to measure PPT at four sites at the knee: also be expressed as area under the curve in order to com- (1) the proximal third of the medial border of the tibia; pare the overall effectiveness of each intervention over the (2) the midpoint of the patella; (3) the distal portion of entire 12 month period. Participant demographics will the rectus femoris muscle, 5 cm superior to the proximal also be included in the models as covariates to assess their border of the patella; (4) the most palpably tender point impact on outcome. The dichotomous measure of success around the knee. A digital pressure algometer (Somedic will be analysed using relative risk, risk reduction and AB, Farsta, Sweden) will measure the pressure applied at a numbers needed to treat in order to facilitate clinical inter- rate of 40 kPa/s to the test site by a rubber-tipped probe pretation of findings and future guidelines. Cost effective- (area 1 cm2) positioned perpendicular to the skin. The ness analysis will evaluate the effectiveness of the participant will activate a button at the precise moment intervention measured using Perceived Treatment Effect that the pressure sensation changes to one of pressure and against resource usage (e.g. physiotherapist fees, equip- pain, which will signal cessation of pressure application ment, medications, etc.), through calculation of the mar- and freeze the pressure reading onscreen for manual ginal cost effectiveness of treatment in terms of dollars per recording. Three measures will be taken at each site and 1-point improvement in outcome. To accommodate for the average calculated to represent the final value. the possibility of inflated Type I error rate resulting from multiple comparisons, significance will be set at 0.01 (i.e., A further questionnaire regarding any adverse reactions to 99% confidence intervals). the intervention and whether any other treatment was sought will be completed at 12 months. Discussion In order to determine the clinical efficacy and cost-effec- All participants will be required to maintain a daily diary tiveness of foot orthoses in the management of PFP, a over the 12 month period, recording activity levels, prob- pragmatic randomised clinical trial is to be conducted. lems with the intervention, analgesia requirements and Based on the Delphi List of criteria for quality assessment compliance with the home exercise program. Visual ana- of RCTs [29], particular methodological factors have been logue scales for usual and worst pain over a week period incorporated into the study design to minimise bias and will also be recorded. optimise the rigor of the RCT. Firstly, participants will be randomly allocated to intervention groups via concealed Sample size considerations allocation. Poor allocation concealment has been shown Sample size calculations for this study are based on the to be associated with bias in RCTs [30]. Secondly, the 100 mm visual analogue scale for usual pain over the past investigator responsible for assessment of outcome at week. The mean difference between baseline and final each time point will remain blind to participants' group score for each group will be compared to measure the allocation. Although it could be argued that the use of effectiveness of each intervention. In order to detect a self-reported primary outcome measures may itself reduce minimal clinically important difference of 15 mm bias associated with an unblinded assessor, blinding of [15,27], assuming a standard deviation of 20 mm [10], a outcome assessors is still an important component due to power of 0.80 and alpha level of 0.01, a sample size of 40 the potential for transfer of attitudes regarding an inter- participants per group will be required. To account for vention from the assessor to the participant [31]. In this dropouts, particularly considering the long duration of study, blinding of participants and the physiotherapists the study [28], a group size of 44 will be recruited, with a administering treatment is not possible due to the nature total sample size of 176. of the interventions used. However, as it has been recom- mended that greater credence should be placed in results Planned statistical analysis where at least the investigators have been blinded to Statistical analysis will be conducted on a blinded, inten- group allocation [31], the single-blind nature of this study tion to treat basis, with all participants who were initially is not deemed to be a methodological flaw. Thirdly, the randomised into the study included where data is availa- investigators responsible for statistical analysis will be ble for each measurement time. SPSS software (Version blind to the treatment group allocation, thereby minimis-
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ing the likelihood of bias associated with their anticipated shaped contoured form of the rear and mid-section of a outcomes. Fourthly, the data analysis will proceed on an moulded orthosis is its active constituent in controlling intention-to-treat basis, which amongst other things, foot motion, especially excessive pronation. It is the con- maintains randomisation, conservatively manages infla- trol of motion that has traditionally been viewed by prac- tion of type I error rate and imitates real life in which it is titioners, and indeed intuitively by patients, as a major somewhat likely that not all patients will receive the ideal function of orthoses [35-37]. To the extent that the con- or intended treatment that has been prescribed. toured form of an orthosis is conceptualised to be its active constituent, the control flat insert may then be As recommended by the CONSORT group [6], the RCT regarded as a placebo. However, it has not been conclu- design has endeavoured to utilise outcome measures that sively proven that orthoses do control motion, with some have established reliability and validity and, where possi- studies indicating no systematic effect on motion [38,39] ble, have been used previously in PFP participants. This and others to the contrary [40-42]. An alternative view is not only enhances the quality of the measurement and that foot orthoses simply serve as space fillers, with their outcomes, but also facilitates direct comparisons with shaped form facilitating full plantar contact [43], which is other studies that have investigated interventions for PFP regarded by some to be clinically beneficial [44,45]. We and possible meta-analyses in the future. Furthermore, contend that the inclusion of a flat insert as an experimen- the selection of clinically applicable primary outcome tal control condition is especially important due to the measures that are easily administered in a clinical setting inconsistencies in findings and viewpoints surrounding improves the clinical relevance of study findings. foot orthoses.
The foot orthoses chosen for use in the RCT are a range of In summary, the RCT to be conducted will utilise high- prefabricated devices that are widely used in Australian quality methodologies in accordance with CONSORT clinical practice. These orthoses were chosen over a cus- guidelines. It is anticipated that findings from this study tom moulded device on the basis of clinical time will contribute to the limited knowledge base regarding restraints, the higher direct cost of custom moulded the clinical efficacy of foot orthoses in the management of orthoses, and findings from a recent meta-analysis of sim- PFP, and provide clinicians with high-quality evidence ilar benefits for both types of devices in the management upon which to base clinical decision making. of lower limb overuse conditions [32]. In fitting the orthoses, we will adopt an approach based on a key syn- Competing interests optic paper by Nigg et al [33]. On the basis of evidence In the past five years BV has received presenter fees from that does not support the traditional concept that inserts Vasyli International for the purpose of presenting semi- and orthoses are used to align the skeleton, they proposed nars in the prescription and fitting of orthoses. The a new concept for the function and fitting of shoes and involvement in this project by Vasyli International is lim- shoe inserts. This new concept includes the following: (a) ited to the donation of the orthoses and inserts. Although the skeleton has a preferred path for a given movement BV conceptualised and has obtained funding from the task; (b) if an intervention (shoe and/or insert) supports NHMRC for the project and will act as overall co-ordina- this preferred path, muscle activity can be reduced; (c) an tor of the project, he will be blinded to group allocation optimal shoe and/or insert feels comfortable because it and he will not conduct the statistical analyses. As overall reduces muscle activity and the resulting fatigue; and (d) co-ordinator he will deal with all adverse events, in which performance should increase with an optimal shoe and/or case he will be unblinded for that individual so as to best insert since muscle activity is minimised and thus energy manage and report the adverse event. expenditure is reduced. Therefore, the participants' per- ception of comfort will be used as the key guide for the All other authors declare that they have no competing selection and fitting of the appropriate orthoses. Although interests. the orthoses are prefabricated, they do allow for a degree of modification in order to achieve best comfort fit. Once Authors' contributions comfort has been achieved, using the steps outlined in NC and BV were responsible for writing this manuscript. Figure 2, if required, the device will be further modified to BV is the sole chief investigator on the NHMRC grant improve pain-free performance of a pain provocative #301037, which he conceived and wrote. TM, KC, EB and functional task whilst still being comfortable. This is RD assisted in the study design. All authors have reviewed based on the proposition that the orthoses should mini- and approved this final manuscript. mise the patient's pain during function [34]. Acknowledgements A particular feature of this study is the inclusion of flat This study is funded by the National Health and Medical Research Council inserts as an experimental control. This assumes that the of Australia (Primary Health Care Project Grant #301037).
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PART J:
Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: RCT. BMJ BMJ 2008;337;a1735 doi:10.1136/bmj.a1735
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Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial
Natalie Collins, Kay Crossley, Elaine Beller, Ross Darnell, Thomas McPoil and Bill Vicenzino
BMJ 2008;337;a1735 doi:10.1136/bmj.a1735
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Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial
Natalie Collins, PhD candidate,1 Kay Crossley, principal research fellow,2 Elaine Beller, director, biostatistics,3 Ross Darnell, statistician,1 Thomas McPoil, regents professor,4 Bill Vicenzino, head of division, physiotherapy1
1School of Health and ABSTRACT INTRODUCTION Rehabilitation Sciences, University Objective To compare the clinical efficacy of foot orthoses of Queensland, Brisbane, Australia Patellofemoral pain syndrome, or idiopathic pain 1 4072 in the management of patellofemoral pain syndrome with arising from the anterior knee, is one of the most 2Melbourne School of flat inserts or physiotherapy, and to investigate the common musculoskeletal presentations to general Engineering, University of effectiveness of foot orthoses plus physiotherapy. practice2 and sports medicine clinics.3-8 In a retro- Melbourne, Australia 3 Prospective, single blind, randomised clinical trial. spective survey of 2002 runners presenting to a sports Queensland Clinical Trials Centre, Design School of Population Health, Setting Single centre trial within a community setting in medicine centre, patellofemoral pain syndrome 9 University of Queensland Brisbane, Australia. accounted for 19% of running injuries, whereas a 4Gait Research Laboratory, two year prospective cohort study reported onset of the Participants 179 participants (100 women) aged 18 to Department of Physical Therapies, syndrome in 9% of 282 students of physical education Northern Arizona University, USA 40 years, with a clinical diagnosis of patellofemoral pain aged 17-21.10 The pain is characteristically provoked Correspondence to: B Vicenzino syndrome of greater than six weeks’ duration, who had no [email protected] by activities such as squatting, stair walking, and previous treatment with foot orthoses or physiotherapy in running, and hence impacts on many aspects of daily Cite this as: BMJ 2008;337:a1735 the preceding 12 months. doi:10.1136/bmj.a1735 life, including the ability to perform pain free exercise Interventions Six weeks of physiotherapist intervention or work related activities. Patellofemoral pain syn- with off the shelf foot orthoses, flat inserts, multimodal drome can result in repeat visits to a doctor given its physiotherapy (patellofemoral joint mobilisation, patellar tendency towards chronicity, with 94% of patients taping, quadriceps muscle retraining, and education), or continuing to experience pain up to four years after foot orthoses plus physiotherapy. initial presentation and 25% reporting significant Main outcome measures Global improvement, severity of symptoms up to 20 years later.11 usual and worst pain over the preceding week, anterior Despite the prevalence, chronicity, and impact of knee pain scale, and functional index questionnaire patellofemoral pain syndrome, several systematic measured at 6, 12, and 52 weeks. reviews of interventions attest to a dearth of high 12-17 Results Foot orthosesproduced improvement beyond that quality research on management. One study of flat inserts in the short term, notably at six weeks concluded that the available evidence at that time (relative risk reduction 0.66, 99% confidence interval 0.05 would lead the practitioner to implement a programme to 1.17; NNT 4 (99% confidence interval 2 to 51). No of education, stretching, and strengthening of the thigh 15 significant differences were found between foot orthoses muscles, and possibly foot orthoses. Subsequently a and physiotherapy, or between physiotherapy and high quality randomised controlled trial found that a multimodal physiotherapy programme for six weeks18 physiotherapy plus orthoses. All groups showed clinically was more effective than sham treatment: relative risk of meaningful improvements in primary outcomes over noticeable improvement 3.39 (95% confidence interval 52 weeks. 1.69 to 6.80).19 That study did not, however, compare Conclusion While foot orthoses are superior to flat inserts physiotherapy with the control sham intervention ’ according to participants overall perception, they are beyond six weeks. similar to physiotherapy and do not improve outcomes As an alternative or adjunct to physiotherapy, foot when added to physiotherapy in the short term orthoses are commonly used to treat active people with management of patellofemoral pain. Given the long term patellofemoral pain syndrome. Recently, a systematic improvement observed in all treatment groups, general review of the clinical efficacy of foot orthoses identified practitioners may seek to hasten recovery by prescribing two small clinical trials in people with patellofemoral prefabricated orthoses. pain syndrome.20 These studies suggest that foot Trial registration Australian Clinical Trials Registry orthoses may be of benefit.21 22 No high quality ACTRN012605000463673 and ClinicalTrials.gov randomised controlled trials have evaluated the use NCT00118521. of foot orthoses for treating patellofemoral pain
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syndrome in the short or long term. Evidence to guide METHODS the use of foot orthoses for this common clinical We carried out a pragmatic, single blind, randomised condition is imperative considering the widespread use clinical trial in a community setting for 12 months. The of foot orthoses and the lack of consensus and methods have been described in detail previously.25 controversy surrounding their prescription.23 24 Volunteers from the greater Brisbane, Gold Coast, We evaluated the short and long term clinical and Toowoomba regions of Queensland, Australia efficacy of prefabricated foot orthoses in the treatment responded to advertisements in print media, radio and of patellofemoral pain syndrome compared with flat television media releases, noticeboards, and referrals inserts or physiotherapy alone, and evaluated whether from practitioners. Eligibility criteria were based on a orthoses improved the effects of physiotherapy. We previous clinical trial19: age 18-40 years; insidious onset hypothesised that foot orthoses would be superior to of anterior knee or retropatellar pain of greater than six flat inserts and equivalent to physiotherapy and that the weeks’ duration and provoked by at least two of combination of foot orthoses and physiotherapy would prolonged sitting or kneeling, squatting, running, be superior to physiotherapy alone. hopping, or stair walking; tenderness on palpation of the patella, or pain with step down or double leg squat; and worst pain over the previous week of at least 30 mm on a 100 mm visual analogue scale. Exclusion criteria were concomitant injury or pain from the hip, lumbar Telephone screening (n=1530) spine, or other knee structures; previous knee surgery; Excluded (n=1034): patellofemoral instability; knee joint effusion; any foot Did not meet inclusion criteria (n=484) condition that precluded use of foot orthoses; allergy to Met exclusion criteria (n=360) Declined to participate (n=9) strapping tape; use of physiotherapy or foot orthoses Did not attend or cancelled screening appointment (n=68) within the previous year; or use of anti-inflammatory Unable to be contacted (n=102) drugs. Other (n=11)
Physical screening (n=496) Protocol To facilitate concealment of allocation, a blinded Excluded (n=313): Did not meet inclusion criteria (n=122) assessor not involved in the randomisation process Met exclusion criteria (n=144) determined eligibility. The randomisation sequence Declined to participate (n=16) was drawn up and kept off site by an independent body, Did not attend or cancelled baseline appointment (n=6) Unable to be contacted (n=6) using a random number generator in blocks of eight Other (n=19) with no stratification. Participants gave written informed consent and, after we had obtained baseline Informed consent Baseline outcome measures measures, were randomly assigned to receive one of four treatments: foot orthoses, flat inserts, physio- Pilot participants (n=4) therapy, or foot orthoses plus physiotherapy. A
Randomisation (n=179) research assistant communicated with the randomisa- tion centre, participants, and project physiotherapists throughout the trial, thus ensuring that the assessor Foot orthoses plus Physiotherapy (n=45) Foot orthoses (n=46) Flat inserts (n=44) responsible for outcome measurement and data physiotherapy (n=44) Received allocated Received allocated Received allocated analysis remained blind to group allocation. Received allocated intervention (n=41) intervention (n=41) intervention (n=36) intervention (n=39) Did not receive Did not receive Did not receive Did not receive intervention intervention intervention Interventions intervention according to protocol: according to protocol: according to protocol: according to protocol: attended fewer than attended fewer than attended fewer than Interventions were administered by one of 17 regis- attended fewer than 6 sessions (n=4) 6 sessions (n=5) 6 sessions (n=6) tered physiotherapists who underwent training for 6 sessions (n=5) Crossed over to foot orthoses at each treatment protocol. Participants attended six 12 weeks (n=2) appointments of 20-60 minutes’ duration over six weeks, after which they were encouraged to continue Follow-up: Follow-up: Follow-up: Follow-up: with a self management programme. 6 weeks (n=42) 6 weeks (n=41) 6 weeks (n=41) 6 weeks (n=40) The intervention programmes have been detailed 12 weeks (n=40) 12 weeks (n=41) 12 weeks (n=42) 12 weeks (n=38) 25 52 weeks (n=43) 52 weeks (n=42) 52 weeks (n=45) 52 weeks (n=41) previously. In brief, participants assigned to foot orthoses received prefabricated, commercially avail- Completed trial (n=43) Completed trial (n=42) Completed trial (n=45) Completed trial (n=41) able orthoses (Vasyli International), which were fitted Lost to follow-up: Lost to follow-up: Lost to follow-up: Lost to follow-up: to their shoes with comfort as a primary goal. These unable to be unable to be died (n=1) unable to be contacted (n=1) contacted (n=3) contacted (n=3) orthoses are customisable to some degree to optimise comfort through heat moulding and by adding wedge Analysed (n=43) Analysed (n=42) Analysed (n=45) Analysed (n=41) or heel raises. As a control for these orthoses we used Excluded from Excluded from Excluded from Excluded from flat inserts, manufactured from the same material analysis (n=0) analysis (n=0) analysis (n=0) analysis (n=0) (ethylenevinyl acetate) with identical covering fabric. These were of uniform thickness, with no inbuilt arch Fig 1 | Flow of participants through study or wedging. Physiotherapy consisted of a combined page 2 of 8 BMJ | ONLINE FIRST | bmj.com RESEARCH Downloaded from bmj.com on 24 October 2008
Table 1 | Baseline characteristics of participants for intervention groups and study cohort. Values are mean (SD) unless stated otherwise
Foot orthoses Flat inserts Physiotherapy Foot orthoses plus Characteristics (n=46) (n=44) (n=45) physiotherapy (n=44) Total (n=179) Age (years) 27.9 (5.3) 29 (6.0) 30.9 (5.8) 29.6 (5.6) 29.3 (5.8) No (%) of women 25 (54.3) 20 (45.5) 29 (64.4) 26 (59.1) 100 (55.9) Height (cm) 172.8 (9.1) 174.9 (10.5) 170.9 (8.4) 173.3 (9.6) 173 (9.5) Weight (kg) 78.5 (20.4) 73.8 (15.9) 70.9 (14.6) 75.2 (22.3) 74.7 (18.6) Body mass index 26.1 (5.6) 23.9 (3.5) 24.2 (4.7) 24.8 (6.2) 24.8 (5.1) Physical activity* (kcal/kg) 40.6 (7.1) 41.3 (7) 41.2 (7.3) 40.8 (8.1) 41 (7.3) No (%) with bilateral knee pain 26 (56.5) 25 (56.8) 26 (57.8) 25 (56.8) 102 (57) Median (interquartile range) duration 42 (12.3-96) 24 (12-71) 37 (12.3-84.8) 24 (9-60) 28 (12-84) of knee pain (months) Usual pain† 38.6 (16) 32.8 (15.1) 34.1 (17.0) 39.8 (17.6) 36.3 (16.6) Worst pain† 59.4 (15.3) 56.6 (14.9) 61.4 (15.6) 64.8 (17.0) 60.5 (15.9) Anterior knee pain scale‡ 70.8 (9.0) 72.1 (9.3) 71.7 (11.3) 71.5 (9.8) 71.5 (9.8) Functional index questionnaire§ 10 (1.9) 10 (1.9) 10 (2.6) 9.3 (2.0) 9.8 (2.1) *Physical activity over previous week questionnaire, total energy expended per day. †Pain measured on 100 mm visual analogue scale; 0 mm=no pain, 100 mm=worst pain imaginable. ‡0-100 points; 100=no disability. §0-16 points; 16=no disability.
therapy approach that has proved efficacious in visual analogue scale for usual pain.26 29 Assuming a patellofemoral pain syndrome19 and included patellar standard deviation of 20 mm,19 a power of 0.80, and an mobilisation, patellar taping, a progressive programme α level of 0.01, we required 40 participants in each of vasti muscle retraining exercises with electromyo- group. We increased the sample size by 10%, to 176 (44 graphic biofeedback, hamstring and anterior hip in each group), to allow for loss to follow-up. stretches, hip external rotator retraining, and a home exercise programme. Participants assigned to orthoses Statistical analysis plus physiotherapy received both interventions as Statistical analysis was done on a blinded, intention to described and had an extra appointment with the treat basis using SPSS software (version 15.0). We physiotherapist if more time was required for adequate chose the primary end points of 6, 12, and 52 weeks, as delivery of all treatment components. six weeks (immediately after the treatment period) The participants were encouraged to continue could be considered to be the time of greatest effect, exercise and activities that did not provoke their pain. 12 weeks is a standard follow-up time in studies of The use of non-study interventions was discouraged patellofemoral pain syndrome,30-33 and the long term throughout the trial, although over the counter drugs (52 weeks) efficacy of foot orthoses or this specific were permitted. Any cointerventions used for symp- physiotherapy programme has not been investigated. toms of patellofemoral pain syndrome, as well as any The dichotomous measure of success was expressed as adverse effects arising from intervention, were relative risk reduction and numbers needed to treat. recorded in diaries, reported to the research assistant, We analysed continuous outcome measures using or detailed in an exit questionnaire. univariate analysis of covariance, with baseline as a covariate and group allocation as a fixed factor. We Outcomes included the characteristics of the participants and The blinded assessor carried out reliable and valid other baseline outcome measures as covariates in outcome measures25 26 before randomisation (baseline) statistical models to determine their impact on out- and at 6, 12, and 52 weeks after randomisation. The come. Significance was set at 0.01 to accommodate the primary outcome measures were global possibility of an inflated type I error rate resulting from improvement,25 severity of usual and worst pain over multiple comparisons. the preceding week, the anterior knee pain scale,27 and the functional index questionnaire.28 We measured RESULTS global improvement on a five point Likert scale From May 2004 to May 2006, 1530 volunteers were (“marked improvement” to “marked worsening”) and screened and 179 enrolled in the study (fig 1). The trial visual analogue scale (−100 mm=much worse, 0=same, was completed in June 2007, with 164 participants 100=completely better). We reduced categorical data (92%) followed up at six weeks, 161 (90%) at 12 weeks, to success equating marked or moderate and 171 (96%) at 52 weeks. With the exception of improvement.19 duration, all groups were well matched at baseline (table 1). Including baseline data as covariates did not Sample size significantly influence outcomes. We based the sample size calculations on a clinically Significant effects favoured foot orthoses over flat meaningful improvement of 15 mm on a 100 mm pain inserts at six weeks, with differences of 19.8 mm (99%
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Table 2 | Absoluteeventratesofsuccessofglobaleffectand comparisonsbetweengroupsfor dichotomousmeasure ofsuccess expressed asrelativeriskreductions and numbers needed to treat (NNT)
No (%) moderately or markedly improved* Between group differences (99% CI)† Foot orthoses plus Foot orthoses plus Foot orthoses Physiotherapy v foot physiotherapy v Follow-up Foot orthoses Flat inserts Physiotherapy physiotherapy v flat inserts orthoses physiotherapy 6 weeks 35/41 (85) 23/40 (58) 38/41 (93) 38/42 (90) 0.66 (0.05 to 1.17)‡; 0.5 (−0.84 to 1.85); −0.3 (−2.83 to 2.24); NNT 4 (2 to 51)‡† NNT 14 (−8to4) NNT −45 (−5to6) 12 weeks 34/42 (81) 30/38 (79) 34/41 (83) 38/40 (95) 0.1 (−0.99 to 1.2); 0.1 (−1.06 to 1.25); 0.71 (−0.44 to 1.87); NNT 50 (−5to4) NNT 51 (−5to4) NNT 8 (−13 to 3) 52 weeks 38/45 (84) 30/41 (73) 34/42 (81) 35/43 (81) 0.42 (−0.43 to 1.24); −0.22 (−1.6 to 1.14); 0.02 (−1.13 to 1.18); NNT 9 (−9to3) NNT −29 (−4to6) NNT 226 (−5to4) *Participants rated improvement on five point Likert scale of global effect. †Positive point estimate favours first listed condition. ‡Significant at P=0.01.
confidence interval 4.0 to 35.6) on the continuous scale orthoses, physiotherapy, foot orthoses plus physio- of global improvement, a number needed to treat of 4 therapy) also had clinically meaningful improvements (2 to 51) on the categorical scale (success equating in usual pain severity, whereas the improvement in marked and moderate improvement), and success rates usual pain for the group receiving flat inserts was of 85% (35/41) for foot orthosesand 58%(23/40) for flat slightly less than 20 mm. No significant differences inserts (fig 2, tables 2 and 3). These trends were were found between groups on any primary measure at mirrored when the categorical data on global improve- 52 weeks. ment were collapsed to success equating marked improvement at six and 12 weeks. At six and Cointerventions 12 weeks no significant differences were found in Table 4 outlines the participants’ use of cointerven- global improvement between physiotherapy and foot tions. No significant differences were found in reported orthoses, or between physiotherapy and combined rates of use between foot orthoses and flat inserts (14/ physiotherapy and orthoses (tables 2 and 3). For each 40, 35% v 15/39, 38%; relative risk reduction 0.09, 99% − of the three a priori pairwise comparisons no significant confidence interval 0.6 to 0.76), physiotherapy and v − − differences were found between the groups on other foot orthoses (16/43, 37% 14/40, 35%; 0.06, 0.78 to outcome measures (table 3). 0.68), or foot orthoses plus physiotherapy and physio- therapy alone (9/40, 23% v 16/43, 37%; 0.4, −0.3 to Over 52 weeks all groups had clinically meaningful 1.01). Two participants assigned to flat inserts crossed improvements in worst pain severity (>20 mm on pain over to foot orthoses after 12 weeks. visual analogue scale), anterior knee pain scale (>10 points), and functional index questionnaire (>2 points; Side effects tables 1 and 3). 26 Three of the four groups (foot A greater proportion of participants reported mild side effects with the foot orthoses (foot orthoses 31/43, 72%; Marked Moderate Same Moderate Marked improvement improvement worsening worsening foot orthoses plus physiotherapy 20/41, 49%) than with 100 the flat inserts (15/39, 38%; relative risk reduction −0.58, 99% confidence interval −1.01 to −0.09). These consisted of rubbing and blistering, discomfort, and 80
Percentage pain in the toes, feet, and ankles, which on the whole responded to increasing wear and minor adjustments 60 to the orthoses (for example, heat moulding and additions) and did not prevent wearing of the orthoses 40 or inserts. Thirty four participants (physiotherapy 18/ 44, 41%; foot orthoses plus physiotherapy 16/41, 39%; 20 relative risk reduction 0.05, −0.59 to 0.67) reported a reaction to daily patellar taping (for example, skin 0 irritation, blistering). Two participants (physiotherapy py py py group and foot orthoses group) experienced low back nserts nserts nserts Orthoses Orthoses otherapy Orthoses Flat i Flat i Flat i pain that required additional physiotherapy. Physiothera Physiothera Physiothera DISCUSSION Foot orthoses produced short term improvements Orthoses plus physiotherapy Orthoses plus physi Orthoses plus physiotherapy beyond that of flat inserts, with the number needed to 6 weeks 12 weeks 52 weeks treat indicating that four patients would need to be Fig 2 | Percentage of participants rating perceived improvement across categories from marked treated with orthoses to have one additional patient improvement to marked worsening experience improvement in patellofemoral pain. Foot page 4 of 8 BMJ | ONLINE FIRST | bmj.com RESEARCH Downloaded from bmj.com on 24 October 2008
orthoses were similar in effect to physiotherapy, and exclusion of participants with known allergies to tape. combining foot orthoses with physiotherapy did not It is difficult to know whether this is abnormally high provide additional improvement beyond physio- due to inadequate reporting in previous trials, but therapy alone. In the long term, clinically meaningful should be considered in clinical application. improvements occurred in pain and function for all The prescription of foot orthoses for musculoskeletal interventions but no differences were found between pain is characterised by a lack of evidence from high interventions. The overall pattern of effect implies that quality clinical trials.15 20 Our study provided level II foot orthoses and physiotherapy each hasten resolution evidence for the use of foot orthoses in patellofemoral of the condition, which is an important benefit for a pain syndrome. Our data corroborate findings from a common, chronic condition. smaller study of 20 adolescent females aged 13 to 17, Treatment costs are a further consideration for which found statistically significant improvements in practitioners and their patients. Assuming recom- pain during gait, sitting, and squatting after eight weeks mended retail pricing, in addition to consultation fees of treatment.21 The authors did not supply point (usually between two to four consultations), the estimates of effect. Furthermore, the magnitude of the orthoses (three pairs, including additions) would cost effect of physiotherapy that we observed on primary $A174 (£79; €100) compared with $A45 for three flat outcome measures at six weeks was comparable with inserts. This would seem to be a reasonable alternative that of another study.19 to physiotherapy (six sessions at around $A495, Some authors contend that the contoured form of including tape). A cost benefit analysis is required to foot orthoses is critical for controlling foot motion, investigate this further. usually excessive pronation.34-36 This exists despite The interventions used in this trial, including the flat three key issues, all of which impinge on the conduct of inserts, produced only mild side effects in the early a randomised controlled trial. Firstly, research shows phase of treatment. Despite the orthoses having generally equivocal and non-systematic effects of the relatively more minor side effects than the flat inserts, ability of foot orthoses to control motion.37-39 Secondly, they showed a greater improvement in the first six alternative means may be available by which foot weeks, suggesting that these side effects did not orthoses exert clinical effects, such as by serving as adversely influence treatment outcomes. About 40% space fillers to facilitate full plantar contact,40 which of participants who received the physiotherapy inter- some regard to be clinically beneficial.41 42 Thirdly, vention (with or without foot orthoses) experienced previous research has failed to show that people with skin reactions with daily taping of the patella, despite patellofemoral pain syndrome have excessive foot
Table 3 | Mean(SD)scoresandmeandifference(99%confidenceintervals)betweengroupsforcontinuousprimaryoutcomemeasuresat6,12,and52weeks(adjusted for baseline), according to intervention for patellofemoral pain syndrome
Mean (SD) for each group Mean (99% CI) differences between groups Foot orthoses Foot orthoses plus plus Foot orthoses v flat Physiotherapy v physiotherapy v Variables Foot orthoses Flat inserts Physiotherapy physiotherapy inserts foot orthoses physiotherapy Global improvement (−100-100)*: 6 weeks 37.6 (27.2) 17.8 (27.2) 45.4 (27.2) 48.7 (27.2) 19.8 (4.0 to 35.6)† 7.8 (−7.8 to 23.5) 3.2 (−12.3 to 18.8) 12 weeks 46.7 (32.8) 30.6 (32.8) 53.4 (32.8) 61.8 (32.8) 16.1 (−3.0 to 35.3) 6.7 (−12.1 to 25.5) 8.4 (−10.7 to 27.4) 52 weeks 52.3 (39.8) 49.9 (39.8) 54.7 (39.8) 55.2 (39.8) 2.4 (−20.0 to 24.8) 2.4 (−19.9 to 24.7) 0.5 (−22.0 to 23.0) Usual pain (0-100 mm)‡: 6 weeks 25.4 (17.4) 33.4 (17.5) 21.2 (17.3) 19.4 (17.4) −8(−18.1 to 2.1) −4.2 (−14.2 to 5.8) −1.8 (−11.8 to 8.2) 12 weeks 22.1 (17.8) 24.5 (18) 20.1 (17.8) 16.4 (17.9) −2.4 (−12.9 to 8.1) −2(−12.2 to 8.2) −3.7 (−14.1 to 6.6) 52 weeks 16.2 (18.5) 17.9 (18.6) 13.9 (18.5) 14.4 (18.6) −1.7 (−12.2 to 8.8) −2.2 (−12.6 to 8.1) 0.4 (−10.1 to 10.9) Worst pain (0-100 mm)‡: 6 weeks 39.8 (21.7) 48 (21.8) 32.2 (21.6) 28.5 (21.9) −8.1 (−20.7 to 4.4) −7.7 (−20.2 to 4.8) −3.6 (−16.0 to 8.8) 12 weeks 33.3 (22.2) 35 (22.4) 26.8 (22.2) 26.5 (22.3) −1.7 (−14.7 to 11.3) −6.5 (−19.2 to 6.2) −0.2 (−13.1 to 12.7) 52 weeks 27.6 (23.7) 26.1 (23.9) 22.2 (23.7) 18.8 (23.9) 1.5 (−11.9 to 15.0) −5.5 (−18.8 to 7.9) −3.3 (−16.8 to 10.1) Anterior knee pain scale (0-100)*: 6 weeks 79.7 (9.1) 74.8 (9.1) 83.4 (9.1) 83.6 (9.1) 4.9 (−0.4 to 10.2) 3.7 (−1.6 to 9.0) 0.2 (−5.0 to 5.5) 12 weeks 81.8 (9.9) 80.9 (9.9) 84.9 (9.9) 86.7 (9.9) 0.9 (−4.9 to 6.6) 3.1 (−2.5 to 8.8) 1.8 (−4.0 to 7.5) 52 weeks 85.5 (9.7) 86.9 (9.7) 87.9 (9.7) 91.5 (9.7) −1.5 (−7.3 to 4.4) 2.5 (−3.3 to 8.2) 3.6 (−2.5 to 9.7) Functional index questionnaire (0-16)*: 6 weeks 11.8 (2.3) 11.1 (2.3) 12.9 (2.3) 13.3 (2.3) 0.7 (−0.6 to 2.0) 1.0 (−0.3 to 2.3) 0.5 (−0.8 to 1.8) 12 weeks 12.3 (2.3) 12.0 (2.3) 13.3 (2.3) 13.9 (2.3) 0.2 (−1.1 to 1.6) 1.0 (−0.3 to 2.4) 0.6 (−0.8 to 1.9) 52 weeks 13.0 (2.6) 13.4 (2.6) 14.2 (2.6) 13.8 (2.6) −0.5 (−1.9 to 1.0) 1.3 (−0.2 to 2.7) −0.5 (−1.9 to 1.0) *Positive score favours reference group (first group listed in comparison). †Significant at P=0.01. ‡Negative score favours reference group.
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Table 4 | Participant reported use of cointerventions for patellofemoral pain during trial*
Foot orthoses Physiotherapy Foot orthoses plus Additional intervention (n=40) Flat inserts (n=39) (n=43) physiotherapy (n=40) Total (n=162) None 26 24 27 31 108 General practitioner or specialist 3 0 0 1 4 Physiotherapy 3 1 1 2 7 Foot orthoses 0 3† 10 4 Massage 1 0 1 0 2 Over counter drugs‡ 11 12 13 7 43 Prescription drugs‡ 01 0 0 1 Acupuncture 1 0 0 1 2 Complementary medicine 1 2 3 2 8 Heat rub 1 0 1 1 3 Ice or heat 4 0 1 1 6 Knee brace 1 0 0 1 2 *Some participants used more than one additional intervention. †Includes two participants who crossed over to receive foot orthoses after 12 weeks as recommended by trial physiotherapists. ‡Analgesics and non-steroidal anti-inflammatory drugs.
pronation compared with controls.10 43 On the basis of with 8% of primary outcome data missing at six weeks, these issues, we included in our randomised controlled 10% at 12 weeks, and 4% at 52 weeks. trial a flat shoe insert to evaluate the clinical efficacy of Unlike other clinical trials, we did not select those the contoured form of foot orthoses.25 Our findings of a treated with foot orthoses on the basis of foot posture clinically beneficial effect in favour of the contoured (for example, excessive pronation22), largely because orthoses provides a solid foundation on which to no valid method currently exists to identify a priori consider the mechanisms of action of foot orthoses and those who may benefit from foot orthoses. It is possible plan future research. that participants fitted with orthoses in our trial were Point estimates of effect between foot orthoses and (randomly) heterogeneous for foot posture, yet we still flat inserts were detected by using measures of global found small but beneficial effects of prescribing foot improvement, but not by using measures of pain or orthoses compared with flat inserts. Conceivably, if the physical function, even though these measures were classification of patients becomes possible,45 then the sensitive to change over time within each group. This point estimates of effect we report are likely to be an reflects the moderate correlations between global underestimate. improvement rating scales and these measures of The characteristics of the participants in our trial pain and function reported by researchers26 in their were similar to those reported by others for age, height, evaluation of outcome measures used in their rando- sex, proportion with bilateral patellofemoral pain mised controlled trial.19 They recommended that syndrome, duration of condition, severity of pain, clinical trials of patellofemoral pain syndrome incor- anterior knee pain scale, and functional index porate a measure of perceived global response to questionnaire.10 19 30 33 Feasibly this represents the treatment, largely on the basis that this scale feasibly broader population of patients with patellofemoral encompasses many dimensions of patellofemoral pain pain syndrome who visit general medical practices and syndrome that are meaningful to the patient (for strengthens the external validity of the findings of our example, pain, function, disability, participation, study. Further reinforcing the external validity of our psychosocial factors). It is likely that a rating of global findings we used physiotherapists from primary care improvement captures more comprehensively the practices in the community, and with only a short patient experience, a notion that requires further duration of training in the protocol (about 1.5 days) exploration to understand better the clinical relevance. they were able to successfully implement an effective foot orthosis intervention, which had a similar effect to Strengths and limitations the multimodal physiotherapy programme. The prescription of foot orthoses for musculoskeletal A limitation of this study is the number of pain is characterised by a lack of solid evidence from comparisons between groups. Although we used 99% quality clinical trials.20 We studied the long term confidence limit to assist in control of type I errors, it is efficacy of foot orthoses in the management of possible that the significant finding between foot patellofemoral pain syndrome. This is a clinically orthoses and flat inserts was due to chance. Notwith- important issue as the condition is highly prevalent and standing this, a number needed to treat of 4 could be foot orthoses are prescribed worldwide. We incorpo- regarded as a clinically meaningful effect and in part rated the recommendations from the consolidated counters the possibility of a type I error in the standards of reporting trials into the methodological comparison of orthoses with flat inserts at six weeks. design, which further strengthens the validity of A further limitation was that we did not include a findings.44 Importantly, the attrition rate was low, control group for clinical course so we cannot page 6 of 8 BMJ | ONLINE FIRST | bmj.com RESEARCH Downloaded from bmj.com on 24 October 2008
2 Van Middelkoop M, van Linschoten R, Berger MY, Koes BW, WHAT IS ALREADY KNOWN ON THIS TOPIC Bierma-Zeinstra SM. Knee complaints seen in general practice: active sport participants versus non-sport participants. BMC Musculoskelet Patellofemoral pain syndrome is highly prevalent in sports medicine and presents often to Disord 2008;9:36. general practices 3 Ballas MT, Tytko J, Cookson D. Common overuse running injuries: diagnosis and management. Am Fam Physician 1997;55:2473-84. Footorthosesare oftenprescribeddespitealackofevidencehighlightedbysystematicreviews 4 Baquie P, Brukner P. Injuries presenting to an Australian sports medicine centre: a 12-month study. Clin J Sport Med 1997;7:28-31. WHAT THIS STUDY ADDS 5 Clement DB, Taunton SE, Smart GW, McNicol KL. A survey of overuse running injuries. Phys Sportsmed 1981;9:47-58. Foot orthoses produce earlier and larger improvements in patellofemoral pain syndrome than 6 DeHaven KE, Lintner DM. Athletic injuries: comparison by age, sport, flat inserts and gender. Am J Sports Med 1986;14:218-24. 7 Devereaux MD, Lachmann SM. Patello-femoral arthralgia in athletes Adding foot orthoses to physiotherapy does not improve physiotherapy outcomes attending a sports injury clinic. Br J Sports Med 1984;18:18-21. 8 Matheson GO, Macintyre JG, Taunton JE, Clement DB, Lloyd-Smith R. Musculoskeletal injuries associated with physical activity in older adults. Med Sci Sports Exerc 1989;21:379-85. decisively conclude that foot orthoses or physio- 9 Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running therapy were better than no treatment over 52 weeks. injuries. Br J Sports Med 2002;36:95-101. Nevertheless, a case may be made for intervening with 10 Witvrouw E, Lysens R, Bellemans J, Cambier D, Vanderstraeten G. foot orthoses or physiotherapy as over 80% of Intrinsic risk factors for the development of anterior knee pain in an athletic population. A two-year prospective study. Am J Sports Med participants in our study were improved at 52 weeks, 2000;28:480-9. compared with 50% of participants followed up at four 11 Nimon G, Murray D, Sandow M, Goodfellow J. Natural history of years in a prospective long term study of the clinical anterior knee pain: a 14- to 20-year follow-up of nonoperative management. JPediatrOrthop1998;18:118-22. 11 course of patellofemoral pain syndrome. 12 Arroll B, Ellis-Pegler E, Edwards A, Sutcliffe G. Patellofemoral pain syndrome: a critical review of the clinical trials on nonoperative therapy. Am J Sports Med 1997;25:207-12. Conclusions 13 Bizzini M, Childs JD, Piva SR, Delitto A. Systematic review of the quality Prefabricated foot orthoses are superior to flat inserts in of randomized controlled trials for patellofemoral pain syndrome. J the short term management of patellofemoral pain Orthop Sports Phys Ther 2003;33:4-20. 14 BrosseauL,CasimiroL,RobinsonV,MilneS,SheaB,JuddM,etal. syndrome, implying that their contoured shape is Therapeutic ultrasound for treating patellofemoral pain syndrome. therapeutic. We found no differences between the Cochrane Database Syst Rev 2001;(4):CD003375. 15 Crossley K, Bennell K, Green S, McConnell J. A systematic review of effects of foot orthoses and physiotherapy, nor was physical interventions for patellofemoral pain syndrome. Clin J Sport there any benefit of adding foot orthoses to physio- Med 2001;11:103-10. therapy. Considering that all treatment groups showed 16 D’Hondt NE, Struijs PA, Kerkhoffs GM, Verheul C, Lysens R, Aufdemkampe G, et al. Orthotic devices for treating patellofemoral clinically meaningful long term improvements, gen- pain syndrome. Cochrane Database Syst Rev 2002;(2):CD002267. eral practitioners may seek to hasten recovery by 17 Heintjes E, Berger MY, Bierma-Zeinstra SM, Bernsen RM, Verhaar JA, prescribing foot orthoses. Koes BW. Exercise therapy for patellofemoral pain syndrome. Cochrane Database Syst Rev 2003;(4):CD003472. We thank Vasyli International for providing the foot orthoses and flat 18 McConnell J. The physical therapist’s approach to patellofemoral inserts; Ausmedic and Access Health for supplying concessions on the disorders. Clin Sports Med 2002;21:363-87. purchase of equipment used in the physiotherapy interventions; the 19 CrossleyK, BennellK, Green S, Cowan S, McConnellJ. Physical therapy project physiotherapists and their practice staff; Jenny McConnell for her for patellofemoral pain: a randomized, double-blinded, placebo- controlled trial. Am J Sports Med 2002;30:857-65. assistance in running the protocol workshops; and research assistants 20 Collins N, Bisset L, McPoil T, Vicenzino B. Foot orthoses in lower limb Jane Buckley, Bula Elwell, and Erica Williams. overuse conditions: a systematic review and meta-analysis. Foot Contributors: NC recruited and screened the participants, carried out the Ankle Int 2007;28:396-412. baseline and follow-up outcome measures and data entry and analysis, 21 Eng JJ, Pierrynowski MR. Evaluation of soft foot orthotics in the and prepared the manuscript. KC was involved in the methodological treatment of patellofemoral pain syndrome. Phys Ther design and preparation of the manuscript. EB assisted in the trial design 1993;73:62-8; discussion 68-70. and carried out the randomisation procedures. RD advised on the 22 Wiener-Ogilvie S, Jones RB. A randomised trial of exercise therapy and statistical design of the trial and data analysis and interpretation. TM was foot orthoses as treatment for knee pain in primary care. Br J Podiatry involved in the National Health and Medical Research Council grant 2004;7:43-9. 23 McPoil TG, Hunt GC. Evaluation and management of foot and ankle application and trial design and reviewed the manuscript. BV, in his disorders: present problems and future directions. J Orthop Sports capacity as sole chief investigator on the National Health and Medical Phys Ther 1995;21:381-8. Research Council grant, supervised the conduct of the trial, the suitability 24 Nigg BM, Nurse MA, Stefanyshyn DJ. Shoe inserts and orthotics for of included participants, data analysis, and preparation of the manuscript, sport and physical activities. Med Sci Sports Exerc and is guarantor. 1999;31(7 suppl):S421-8. Funding: This trial was funded primarily by the National Health and Medical 25 Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T. Foot Research Council of Australia (primary health care project grant No orthoses and physiotherapy in the treatment of patellofemoral pain 301037). NC was the recipient of a National Health and Medical Research syndrome: a randomised clinical trial. BMC Musculoskelet Disord Council of Australia public health scholarship (No 351663). Vasyli 2008;9:27. International donated the foot orthoses and flat inserts. The work of the 26 Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable authors was independent of the funders. and valid? Arch Phys Med Rehabil 2004;85:815-22. Competing interests: BV has been reimbursed by Vasyli International for 27 Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, seminar presentations and has also received research funding from this Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy company. 1993;9:159-63. Ethical approval: University of Queensland’s medical research ethics 28 Chesworth BM, Culham EG, Tata GE, Peat M. Validation of outcome committee. measures in patients with patellofemoral syndrome. J Orthop Sports Provenance and peer review: Not commissioned; externally peer Phys Ther 1989;10:302-8. reviewed. 29 Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically importantchanges inchronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 2004;8:283-91. 1 Australian Acute Musculoskeletal Pain Guidelines Group. Evidence- 30 Clark DI, Downing N, Mitchell J, Coulson L, Syzpryt EP, Doherty M. based management of acute musculoskeletal pain.Brisbane: Physiotherapy for anterior knee pain: a randomised controlled trial. Australian Academic Press, 2003. Ann Rheum Dis 2000;59:700-4.
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31 Harrison EL, Sheppard MS, McQuarrie AM. A randomized controlled 39 McCulloch MU, Brunt D, Vander Linden D. The effect of foot orthotics trial of physical therapy treatment programs in patellofemoral pain and gait velocity on lower limb kinematics and temporal events of syndrome. Physiother Can 1999;51:93-106. stance. J Orthop Sports Phys Ther 1993;17:2-10. 32 Roush MB, Sevier TL, Wilson JK, Jenkinson DM, Helfst RH, Gehlsen GM, 40 Kogler GF, Solomonidis SE, Paul JP. In vitro method for quantifying the et al. Anterior knee pain: a clinical comparison of rehabilitation effectiveness of the longitudinal arch support mechanism of a foot methods. Clin J Sport Med 2000;10:22-8. orthosis. Clin Biomech (Bristol, Avon) 1995;10:245-52. 33 Witvrouw E, Lysens R, Bellemans J, Peers K, Vanderstraeten G. Open 41 Cornwall MW, McPoil TG. Effect of rearfoot posts in reducing forefoot versus closed kinetic chain exercises for patellofemoral pain. A forces. A single-subject design. J Am Podiatr Med Assoc prospective, randomized study. Am J Sports Med 2000;28:687-94. 1992;82:371-4. 34 American College of Foot and Ankle Orthopedics and Medicine. 42 Kogler GF, Solomonidis SE, Paul JP. Biomechanics of longitudinal arch Prescription custom foot orthoses practice guidelines.Bethesda,MD: support mechanisms in foot orthoses and their effect on plantar American College of Foot and Ankle Orthopedics and Medicine, 2004. aponeurosis strain. Clin Biomech (Bristol, Avon) 1996;11:243-52. 43 Powers CM, Chen PY, Reischl SF, Perry J. Comparison of foot pronation 35 Australian Podiatry Council. Clinical guidelines for orthotic therapy and lower extremity rotation in persons with and without provided by podiatrists. East Brunswick, Victoria: Australian Podiatry patellofemoral pain. Foot Ankle Int 2002;23:634-40. Council, 1998. 44 Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. 36 Subotnick SI. Orthotic foot control and the overuse syndrome. Phys The revised CONSORT statement for reporting randomized trials: 1975;3:75-9. Sportsmed explanation and elaboration. AnnInternMed2001;134:663-94. 37 Eng JJ, Pierrynowski MR. The effect of soft foot orthotics on three- 45 Vicenzino B, Collins N, Cleland J, McPoil T. A clinical prediction rule for dimensional lower-limb kinematics during walking and running. Phys identifying patients with patellofemoral pain who are likely to benefit Ther 1994;74:836-44. from foot orthoses: a preliminary determination. Br J Sports Med 26 38 Novick A, Kelley DL. Position and movement changes of the foot with Sep 2008. doi: 10.1136/bjsm.2008.052613. orthotic intervention during the loading response of gait. JOrthop Sports Phys Ther 1990;11:301-12. Accepted: 6 August 2008
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Published 24 October 2008, doi:10.1136/bmj.a1948 Cite this as: BMJ 2008;337:a1948 Editorials Patellofemoral pain syndrome
Usually resolves over time, and intervention offers only limited benefit
Patellofemoral pain syndrome is defined as pain behind or around the patella caused by stress in the patellofemoral joint. Symptoms are usually provoked by climbing stairs, squatting, and sitting with flexed knees for long periods of time. It is a common presentation in general practice and can have a big effect on patients’ ability to work.1 Physiotherapy and foot orthoses available without prescription are often used in the management of patellofemoral pain syndrome. In the linked randomised controlled trial (doi:10.1136/bmj.a1735), Collins and colleagues assess the effectiveness of foot orthoses, flat insoles, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or a combination of foot orthoses and physiotherapy in people with this syndrome.2
The rationale for treatment is to correct unbalanced tracking of the patella. Knee braces, knee taping, knee sleeves, and knee straps all aim to alter the patella’s tracking pattern. Some studies have shown that these strategies improve knee symptoms, although others show no significant difference compared with physiotherapy.3 4 The most commonly recommended treatment is strengthening of the quadriceps along with avoidance of painful activities.5 Straight leg raises are recommended to isometrically strengthen the quadriceps. One cohort study found that increasing hip muscle strength and flexibility has also been successful.6 In this cohort study, after six weeks of hip exercises, improvement of hip muscle function was associated with good results in patellofemoral pain syndrome.
In patients with a flat foot deformity, the foot is pronated causing a compensatory internal rotation of the lower extremity that can disturb the patellofemoral mechanism. In this situation custom made foot orthoses are used to support the medial arch and restore normal leg alignment. Foot orthoses, in addition to an exercise programme, can be effective for people with patellofemoral pain syndrome.7 On the other hand, a recent randomised trial showed no difference in outcome between eight weeks of treatment with functional foot orthoses, exercises, or orthoses combined with exercises.8 Follow-up beyond eight weeks was not available in either of these studies, which limits their value, because patellofemoral pain syndrome tends to become a chronic problem.
The linked study by Collins and colleagues randomised 179 patients with patellofemoral pain syndrome to four interventions of six weeks’ duration.2 The flat insole group can be regarded as a control for the foot orthoses.9 Global improvement, severity of usual and worst pain over the preceding week, the anterior knee pain scale, and the functional index questionnaire were measured at six, 12, and 52 weeks. Foot orthoses significantly improved outcomes at six weeks compared with flat inserts (relative risk 0.66, 99% confidence interval 0.05 to 1.17; number needed to treat 4, 2 to 51). At six weeks patients using foot orthoses or those who performed a supervised exercise programme showed significant improvement compared with those using flat insoles. This study confirms the good results seen for exercise and foot orthoses in the short term.3 At one year follow-up, all groups, including the one using flat insoles, showed a clinically meaningful improvement.
A systematic review found that exercise programmes consisting of either closed chain exercises (where the foot is in contact with a surface) or open chain exercises (where the foot is not in contact with a surface) are equally effective.10 So far, the role of foot orthoses has not been clear. A recent systematic review found no evidence to support the use of any
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orthotic devices in the treatment of patellofemoral pain syndrome.4 Collins and colleagues’ study suggests that foot orthoses can be useful in the short term. They may even be cost effective compared with physiotherapy.
The study also found that all groups, including the placebo group (flat insoles) made a clinically relevant improvement over time. This probably reflects the benign natural history of this syndrome, and raises the question of whether we should interfere at all. High quality randomised controlled trials are needed to answer this question. These should compare the results of knee orthoses, foot orthoses, physiotherapy, and patients without treatment; follow-up should be for at least a year. The limited evidence for the effectiveness of orthotic devices for patellofemoral pain syndrome along with the current results should encourage future researchers to use a control group not receiving any treatment.
Cite this as: BMJ 2008;337:a1948
C Niek van Dijk, professor of orthopaedics, Willem M van der Tempel, surgical house officer
1 Department of Orthopaedic Surgery, Academic Medical Centre, 1100 DD Amsterdam, Netherlands
Research, doi:10.1136/bmj.a1735
Competing interests: None declared. Provenance and peer review: Commissioned; not externally peer reviewed. References
1. Van Middelkoop M, van Linschoten R, Berger MY, Koes BW, Bierma-Zeinstra SM. Knee complaints seen in general practice: active sport participants versus non-sport participants. BMC Musculoskelet Disord 2008;9:36.[CrossRef][Medline] 2. Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. BMJ 2008;337:a1735.[Abstract/Free Full Text] 3. Crossley K, Bennell K, Green S, Cowan S, McConnell J. Physical therapy for patellofemoral pain: a randomized, double-blinded, placebo-controlled trial. Am J Sports Med 2002;30:857-65. [Abstract/Free Full Text] 4. D’hondt NE, Struijs PA, Kerkhoffs GM, Verheul C, Lysens R, Aufdemkampe G, et al. Orthotic devices for treating patellofemoral pain syndrome. Cochrane Database Syst Rev 2002;(2):CD002267. 5. Fulkerson JP. Diagnosis and treatment of patients with patellofemoral pain. Am J Sports Med 2002;30:447-56.[Abstract/Free Full Text] 6. Tyler TF, Nicholas SJ, Mullaney MJ, McHugh MP. The role of hip muscle function in the treatment of patellofemoral pain syndrome. Am J Sports Med 2006;34:630-6. [Abstract/Free Full Text] 7. Sutlive TG, Mitchell SD, Maxfield SN, McLean CL, Neumann JC, Swiecki CR, et al. Identification of individuals with patellofemoral pain whose symptoms improved after a combined program of foot orthosis use and modified activity: a preliminary investigation. Phys Ther 2004;84:49-61. [Abstract/Free Full Text] 8. Wiener-Ogilvie S. A randomised trial of exercise therapy and foot orthoses as treatment for knee pain in primary care. Br J Podiatr 2004;7:43-9. 9. Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trial. BMC Musculoskelet Disord 2008;9:27.[CrossRef][Medline] 10. Heintjes E, Berger MY, Bierma-Zeinstra SM, Bernsen RM, Verhaar JA, Koes BW. Exercise therapy for patellofemoral pain syndrome. Cochrane Database Syst Rev 2003;(4):CD003472.
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Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial Natalie Collins, Kay Crossley, Elaine Beller, Ross Darnell, Thomas McPoil, and Bill Vicenzino BMJ 2008 337: a1735. [Abstract] [Full Text] [PDF]
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EDITORIALS: Rapid Responses: Submit a response to this article C Niek van Dijk and Willem M van der Tempel Patellofemoral pain syndrome BMJ 2008; 337: a1948 [Full text]
Rapid Responses published:
Patellofemoral Pain Syndrome: Important Considerations
Bill Vicenzino, Natalie Collins, Kay Crossley, Thomas McPoil (31 October 2008)
Patellofemoral Pain Syndrome: Important 31 October Considerations 2008
Bill Vicenzino, Chair in Sports Professors van Dijk and van der Tempel[1] have written a good overview of the Physiotherapy and Head of Physiotherapy topic area, our clinical trial[2] and the need for future work to incorporate a School of Health and Rehabilitaiton Sciences, no-treatment control group. We would like to comment on a few of the points The University of Queensland, 4072, Qld, they raise in their editorial. Australia, Natalie Collins, Kay Crossley, Thomas McPoil 1. The relationship between flat foot deformity and patellofemoral pain Send response to journal: syndrome is a widely held clinical notion/observation that is not strongly Re: Patellofemoral Pain supported by research (e.g., [3 ,4]). As such, we were careful not to endorse Syndrome: Important this association in our write-up, and encourage readers to exercise care when Considerations taking this point on board. Aside from there being little concrete evidence of the
link between flat feet and patellofemoral pain syndrome, there is also the issue
of a lack of consistent and solid evidence underpinning the notion that orthoses
support the arch and control excessive pronation (flat feet) and thus alignment
of the lower limb and patella. Our clinical trial shows that foot orthoses with
inbuilt arch support and inversion (supination/varus) wedging/posting are
superior to flat shoe inserts made of the same material. We feel that this
provides evidence that there is some therapeutic property in the shape and
contouring of the orthoses. This requires further evaluation, so that the
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therapeutic characteristics and underlying mechanisms of action of foot
orthoses become more evidence-based.
2. We have recently published a follow up study that may provide some support
for the notion that the orthoses are likely to be more effective in specific
individuals[5]. In this study we detail a clinical prediction rule in which 3 of the
following 4 patient characteristics can be used to improve the likelihood of
marked improvement at 12 weeks from 40% to 85%: (i) age > 25 years, (ii)
height < 165cm, (iii) pain severity < 53mm on 100 mm VAS, and (iv) mid-foot
width difference from non weight bearing to weight bearing > 11mm. The
mid-foot width difference of > 11mm, which can be easily measured with a
vernier caliper[6], identifies those who have greater mobility of the foot when it
is loaded in weight bearing, which is a component of excessive foot pronation.
This may provide some support to the notion enunciated in 1 above.
3. The need for future studies to include a group which follows a 'wait and see
policy', as in previous randomised clinical trials (RCTs) of musculoskeletal
pain[7 ,8], is a valid point and one we support in principle. Enacting such arms
of RCTs is often perceived to be an impediment to recruitment and gaining
ethical approval, and may compromise the trial‚s successful completion.
Notwithstanding this, it is important to understand that the natural history of
many musculoskeletal pain states (or time course of resolution of acute bouts
of pain) are largely not described and so it is difficult to know if some minimal
attempt at intervention (e.g. flat insert) is better than just waiting for resolution.
If we assume that flat inserts provide some Œplacebo effect‚ beyond natural
resolution in the short term, then the use of foot orthoses is likely to speed up
resolution beyond that of natural recovery. Many of our patients present to
clinics with patellofemoral pain that has not resolved, often after a period of
waiting and seeing, and for which they are seeking a speedy resolution of their
pain and subsequent return to pain-free function. In this regard, the findings of
this study, and previous studies that show physiotherapy to be more effective
than placebo in the short term, provides solid direction to both the patient and
practitioner in their quest to return as soon as possible to pain-free participation
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in life.
4. The editorial makes two pertinent statements, that patellofemoral pain
„usually resolves over time‰ and „tends to become a chronic problem‰. The
literature tends to support the latter of these rather than the former. A
prospective longitudinal study found that 94% of 63 adolescent females had
ongoing pain two to four years after initial presentation, while one in four had
significant symptoms up to 20 years later[9]. Cross- sectional studies report
mean patellofemoral pain durations of 43 months (range 6 to 108) [10] and 8
years (range 1 to 25). The median duration of knee pain of our RCT cohort
reflected this chronic tendency (28 months (interquartile range 12 to 84))[2].
Our finding that individuals with patellofemoral pain have considerable
symptom duration suggests that the condition does not spontaneously resolve
5. There are a few minor points that we feel should be further clarified for the
reader:
(a) The study by Wiener-Ogilvie & Jones [11] was a pilot trial that was
substantially underpowered to detect any between-group differences. Hence, to
summarise their data as evidence of no effect is problematic as there is a high
likelihood of a type II error (that is, accepting that there is no effect when in
truth/fact there is an effect).
(b) The editorial makes a summarising statement that our trial confirms the
good results of exercises and orthoses in the short term and cites Crossley et
al[12], presumably in support of that statement. It is erroneous to do such, as
Crossley and colleagues evaluated a multi-modal physiotherapy treatment that
included exercise and tape, but not foot orthoses. Our study was the first
adequately powered, high quality RCT to provide point estimates of effect that
favoured orthoses over flat inserts in the short term.
(c) We note a reference to orthoses being used without prescription in the
opening paragraph that may be misinterpreted by the reader as to mean that
the orthoses used were applied by a lay person, possibly bought across the
counter of a retail outlet. This would be misleading as we used qualified
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physiotherapists who received additional training to fit and modify the orthoses
following a predetermined algorithm (see [13 ,14] for more information). In brief,
the orthoses were prescribed on the basis of fit and comfort in the first instance
and then modified to improve pain- free performance of a previously painful
task. We propose that fitting of orthoses in this way is likely best performed by a
physiotherapist, podiatrist or athletic trainer, but medical practitioners with a
predilection to using physical therapies should also be able to effectively fit
orthoses.
(d) The authors cite a recent systematic review that they state found no
evidence to support the use of any orthotic devices in patellofemoral pain[15].
This conclusion is misleading, as all five included studies evaluated knee
orthotic devices, not foot orthoses. We performed a systematic review and
meta-analysis[16] of more recent publications, which identified two small RCTs
for foot orthoses in patellofemoral pain, one of which was underpowered to
detect between-group differences [11]. Although the other study did not provide
point estimates of effect for calculation of effect sizes, the authors reported a
significantly greater reduction in patellofemoral pain in those treated with foot
orthoses than the group that received flat inserts [17]. This study was not
included in the review by D‚Hondt et al[15] due to a lack of statistical data.
References
1. van Dijk CN, van der Tempel WM. Patellofemoral pain syndrome. BMJ
2008;337(oct24_1):a1948-.
2. Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot
orthoses and physiotherapy in the treatment of patellofemoral pain syndrome:
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Competing interests: None declared
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