Therapeutic Ultrasound for Soft-Tissue Injuries of the Elbow (Protocol)

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol)

Baker KG, Senior HE, Parag V

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2009, Issue 1 http://www.thecochranelibrary.com

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER...... 1 ABSTRACT ...... 1 BACKGROUND ...... 2 OBJECTIVES ...... 2 METHODS ...... 2 ACKNOWLEDGEMENTS ...... 4 REFERENCES ...... 4 ADDITIONALTABLES...... 5 APPENDICES ...... 6 WHAT’SNEW...... 7 HISTORY...... 7 DECLARATIONSOFINTEREST ...... 8 SOURCESOFSUPPORT ...... 8

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) i Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Therapeutic ultrasound for soft-tissue injuries of the elbow

Kerry G Baker2, Hugh E Senior1, Varsha Parag3

1Neurological and Mental Health Division, The George Institute for International Health, Sydney, Australia. 2School of Health Sciences, The University of Newcastle, Callaghan, Australia. 3Clinical Trials Research Unit, University of Auckland, Auckland, New Zealand

Contact address: Hugh E Senior, Neurological and Mental Health Division, The George Institute for International Health, Level 10 King George V Building, Missenden Road, Royal Prince Alfred Hospital, Sydney, NSW 2050, Australia. [email protected].

Editorial group: Cochrane Bone, Joint and Muscle Trauma Group. Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.

Citation: Baker KG, Senior HE, Parag V. Therapeutic ultrasound for soft-tissue injuries of the elbow. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD006368. DOI: 10.1002/14651858.CD006368.

ABSTRACT This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the efﬁcacy of therapeutic ultrasound in the treatment of soft-tissue injuries of the elbow when compared to placebo intervention, no treatment or other types of intervention. To determine the effect of therapeutic ultrasound on function (elbow speciﬁc and general), pain, swelling, and range of motion.

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) 1 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. BACKGROUND alleged to be due to a combination of cavitation, where the sound wave causes gas-filled bubbles in the tissue to expand and con- tract resulting in an increase in fluid flow within the surrounding Description of the condition tissue, and acoustic streaming, where the sound waves cause lo- Lateral epicondylitis (also known as tennis elbow, lateral tendi- calised unidirectional movement of fluids across cells membranes nosis, lateral tendonitis, lateral epicondylalgia and elbow periten- by altering cell membrane permeability and stimulating cell activ- donitis) has been described as the most common source of elbow ity (Ter Haar 1987; Ter Haar 1999). However, whether cavitation pain in the general population (Scuderi 2005). Lateral epicondyli- or acoustic streaming is powerful enough to cause the biophysical tis occurs equally in males and females, usually between the ages effects proposed in vivo at the intensities used for therapeutic ul- of 35 to 50 years (Nirschl 1993). It is a chronic tendonitis of the trasound is debatable (Baker 2001). Pulsing the ultrasound beam extensor muscles of the wrist resulting in lateral elbow pain. Indi- can minimise the thermal effects while maintaining the non-ther- viduals who use repetitive hand movements in their employment mal effect for different therapeutic applications (Ter Haar 1987). are at risk (Ranney 1995), as are tennis players due to repetitive Therapists can control the dose of the ultrasound by altering the extension of the wrist against a resistant force. It can also occur in intensity of the beam and can focus the ultrasound wave to a spe- sports with similar movement such as baseball, swimming, gym- cific tissue depth by adjusting the wave frequency (1 to 3 MHz). nastics and golf (Shaw 2004). Medial epicondylitis (golfer’s elbow) is also a common soft-tissue injury of the elbow but occurs 5 to 10 times less frequently than Why it is important to do this review lateral epicondylitis (Gabel 2000; Leach 1987). It is associated with sports that involve repetitive wrist flexion such as golf, tennis Physical therapy is a common treatment approach. Physiother- and baseball (Scuderi 2005) or as an occupation injury of manual apists have traditionally treated lateral and medial epicondylitis labourers. It is a tendonitis of the flexor-pronator group (respon- using a combination of massage, ice and ultrasound followed by sible for bending the wrist and rotating the forearm) and is caused physical interventions to gradually increase flexibility, strength and by repetitive valgus (outward) force on the flexors of the forearm endurance. There have been a number of reviews on the use of causing pain and tenderness at their origin on the anterior medial therapeutic ultrasound for musculoskeletal injuries (Beckerman epicondyle. The anterior medial epicondyle is a prominence on 1993; Falconer 1990; Gam 1995; Ogilvie-Harris 1995; Van der the inner part of the elbow where the flexor/pronator muscles of Heijden 1997; Van der Windt 1999; Van der Windt 2001). How- the forearm attach via tendons. ever, none of these systematic reviews focused on soft tissue in- Other soft-tissue injuries of the elbow such as posterior tendinosis, juries of the elbow or investigated the effect of different treatment valgus instability, posterolateral rotatory instability, radial (lateral) parameters, and as such a review is warranted to provide clinicians collateral ligament injury and tendon rupture are less common and patients with the current available evidence of its efficacy and than either lateral or medial epicondylitis. safety. The scope of this protocol does not extend to looking at trials comparing ultrasound therapy to surgical procedures. Description of the intervention Therapeutic ultrasound is used to promote healing, reduce pain and modulate inflammation in soft tissues i.e. muscles, ligaments and tendons. It consists of inaudible high-frequency and low in- OBJECTIVES tensity sound waves made by a transducer converting electrical To determine the efficacy of therapeutic ultrasound in the treat- energy into acoustic waves (Ter Haar 1987; Ter Haar 1999). ment of soft-tissue injuries of the elbow when compared to placebo intervention, no treatment or other types of intervention.

How the intervention might work To determine the effect of therapeutic ultrasound on function (elbow speciﬁc and general), pain, swelling, and range of motion. Theoretically, the setting of different insonation parameters will se- lect either thermal or non-thermal ultrasound to provide different therapeutic effects. Both forms of ultrasound will be present, but one will dominate over the other based on the parameters chosen. METHODS The production of heat within tissues due to thermal ultrasound may result in an increase in the extensibility of collagenous struc- tures, change in blood ﬂow, and decrease in joint stiffness, muscle Criteria for considering studies for this review spasm and pain relief (Speed 2001). The non-thermal effects are

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) 2 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Types of studies ter of Controlled Trials (in The Cochrane Library), MED- We will consider the following studies for this systematic review: LINE, EMBASE, CINAHL, AMED, SPORTDiscus, Cur- 1. Randomised controlled trials (RCTs); rent Contents, PEDRo (Physiotherapy Evidence Database: 2. Controlled trials (CCTs) where treatment allocation is pseudo- http://www.pedro.fhs.usyd.edu.au/index.html), Current Con- randomised such as alternating allocation, allocation based on trolled Trials (controlled-trials.com), United Kingdom Na- birth date, or day of inclusion. tional Research Register (http://www.update-software.com/na- tional/), NHS Health Technology Assessment Programme (www.hta.nhsweb.nhs.uk/), Bandolier (www.jr2.ox.ac.uk/ban- Types of participants dolier/), and reference lists of articles. No language restrictions will Participants in trials with soft-tissue injuries of the elbow who be applied. exhibited pain, swelling, and/or functional disability. This will In MEDLINE (OVID Web) the subject-speciﬁc search strategy include trials in which participants have had surgery for the elbow will be combined with the optimal trial search strategy described injury and trials where people have been managed conservatively. in the Cochrane Handbook (Higgins 2005)(see Appendix 1). This will be modiﬁed for other databases.

Types of interventions One group in the controlled trial must involve participants treated Data collection and analysis with active ultrasound therapy. Ultrasound therapy can be compared with either placebo (sham therapeutic ultrasound), no treatment, or other treatments such as medication (non steroidal anti- Selection of studies inﬂammatory drugs (NSAIDs) or paracetamol), immobilisation Two independent reviewers (HS and KB) will examine the titles (including rest, ice, compression, elevation), exercise therapy, elec- and abstracts of articles retrieved by the search and apply the selec- trotherapy (transcutaneous electrical nerve stimulation (TENS), tion criteria. All trials that are classiﬁed as relevant by either of the neuromuscular electrical nerve stimulation (NMES), laser ther- reviewers will be retrieved. The retrieved trials will be re-examined apy, electromyographic (EMG) biofeedback). against the selection criteria, and any disagreement that remains Trials where ultrasound therapy is included in both arms as a will be resolved by consensus, and if necessary a third author (VP). co-intervention will be excluded, as will trials comparing ul- If possible, we will obtain translations for studies published in lan- trasound therapy to surgical procedures and studies comparing guages other than English. phonophoresis with therapeutic ultrasound.

Data extraction and management Types of outcome measures For each publication retrieved, two independent authors (HS and Trials which include at least one of the following outcome measures KB) will extract the necessary details using standardised forms. will be considered for inclusion. Details recorded will be eligibility criteria, interventions (includ- • General functional outcomes (return to previous activity ing characteristics of the therapeutic ultrasound device and its ap- levels, return to work, patient perceived benefit, proportion of plication (duration, frequency, number of sessions, probe prepa- participants recovered, number of sick days, re-uptake of sports, ration), outcome measures, length of follow up, adverse events, ability to lift objects); sample size, statistical analysis (intention to treat). • Grip strength; • Elbow-specific functional status; • Objective testing of function (stability testing or range of Assessment of risk of bias in included studies motion); In this review, risk of bias will be assessed indirectly in terms of • Swelling; different aspects of methodological quality. • Pain (visual analogue scale, ordinal scale, pain All articles included in the review will be assessed independently for questionnaire, pain free grip strength); the methodological quality by two review authors (HS and KB). • Re-injury of the elbow soft tissues within a set time period; This will involve the utilisation of a subject-specific modification • Adverse effects. of the generic evaluation tool used by the Cochrane Bone, Joint and Muscle Trauma Group (see Table 1).

Search methods for identiﬁcation of studies Data synthesis We will search the Cochrane Bone, Joint and Muscle Trauma Relative risks and 95% conﬁdence intervals (CI) will be calcu- Group Specialised Register, the Cochrane Central Regis- lated for dichotomous outcomes, and mean differences and 95%

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) 3 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. confidence intervals calculated for continuous outcomes. Results of therapeutic ultrasound and the type of therapeutic ultrasound of comparable groups of trials will be pooled using the fixed-ef- (continuous or pulsed). Sensitivity analyses will be conducted on fect model and the pooled estimate will have 95% CIs calculated. the effect of allocation concealment of outcome assessors on the Furthermore, heterogeneity between comparable trials would be results of the review. tested by visual inspection of the forest plot and by using a stan- dard chi-squared test and considered to be statistically significant at P < 0.1 in combination with an I² statistic of > 50% (Higgins 2003). Where there is significant heterogeneity between the results ACKNOWLEDGEMENTS of individual trials, and when considered appropriate, the results of the random-effects model will be presented instead of those from The authors would like to thank the Clinical Trials Research Unit, the fixed-effect model. If there are a sufficient number of studies, The University of Auckland for providing support in the develop- subgroup analyses based on sex and age (younger than 65 years, 65 ment of this protocol. years and older) will be employed. Subgroup analyses to explore Our thanks also to Peter Herbison, Lesley Gillespie, Janet Wale, heterogeneity will be based on the dose, frequency and duration David Baxter and Lindsey Shaw for helpful comments on the protocol.

REFERENCES

Additional references Leach 1987 Leach RE, Miller JK. Lateral and medial epicondylitis of the Baker 2001 elbow. Clinics in Sports Medicine 1987;6(2):259–72. Baker KG, Robertson VJ, Duck FA. A review of therapeutic Nirschl 1993 ultrasound: biophysical effects. Physical Therapy 2001;81 Nirschl RP. Muscle and tendon trauma: tennis elbow. (7):1351–8. In: Morrey BF editor(s). The elbow and its disorders. 3rd Beckerman 1993 Edition. Philadelphia: WB Saunders, 2000:523–36. Beckerman H, Bouter LM, Van der Heijden GJ, De Bie Ogilvie-Harris 1995 RA, Koes BW. Efﬁcacy of physiotherapy for musculoskeletal Ogilvie-Harris DJ, Gilbart M. Treatment modalities for soft disorders: what can we learn from research?. British Journal tissue injuries of the ankle: a critical review. Clinical Journal of General Practice 1993;43(367):73–7. of Sport Medicine 1995;5(3):175–86. Falconer 1990 Ranney 1995 Falconer J, Hayes KW, Chang RW. Therapeutic ultrasound Ranney D, Wells R, Moore A. Upper limb musculoskeletal in the treatment of musculoskeletal conditions. Arthritis disorders in highly repetitive industries: precise anatomical Care & Research 1990;3(2):85–91. physical ﬁndings. Ergonomics 1995;38(7):1408–23. Gabel 2000 Scuderi 2005 Gabel GT, Morrey BF. Medial epicondylitis. In: Morrey Scuderi GR, McCann PD. Sports medicine: a comprehensive BF editor(s). The elbow and its disorders. 3rd Edition. approach. 2nd Edition. Philadelphia: Elsevier Mosby, 2005. Philadelphia: WB Saunders, 2000:537–42. Shaw 2004 Gam 1995 Shaw J, O’Connor FG, Nirschl RP. Elbow. In: Birror RB, Gam AN, Johannson F. Ultrasound therapy in O’Connor FG editor(s). Sports medicine for the primary care musculoskeletal disorders: a meta-analysis. Pain 1995;63 physician. 3rd Edition. Boca Raton: CRC Press, 2004. (1):85–91. Speed 2001 Higgins 2003 Speed CA. Therapeutic ultrasound in soft tissue lesions. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Rheumatology 2001;40(12):1331–6. Measuring inconsistency in meta-analyses. BMJ 2003;327 Ter Haar 1987 (7414):557–60. Ter Haar G. Basic physics of therapeutic ultrasound. Physiotherapy 1987;73(3):110–3. Higgins 2005 Higgins JPT, Green S, editors. Highly sensitive search Ter Haar 1999 strategies for identifying reports of randomized controlled Ter Haar G. Therapeutic ultrasound. European Journal of trials in MEDLINE. Cochrane Handbook of Systematic Ultrasound 1999;9(1):3–9. Reviews of Interventions 4.2.5 [updated May 2005]; Van der Heijden 1997 Appendix 5b. www.cochrane.org/resources/handbook/ Van der Heijden GJ, Van der Windt DA, De Winter hbook.htm (accessed 14 Nov 2006). AF. Systematic review of randomised clinical trials of

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) 4 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. physiotherapy for soft tissue shoulder disorders. BMJ 1997; 315:25–30. Van der Windt 1999 Van der Windt DAWM, Van der Heijden GJMG, Van den Berg SGM, Ter Riet G, De Winter AF, Bouter LM. Ultrasound therapy for musculoskeletal disorders: a systematic review. Pain 1999;81(3):257–71. Van der Windt 2001 Van der Windt DAWM, Van der Heijden GJMG, Van den Berg SGM, Ter Riet G, De Winter AF, Bouter LM. Therapeutic ultrasound for acute ankle sprains. Cochrane Database of Systematic Reviews 2006, Issue 3.[Art. No.: CD001250. DOI: 10.1002/14651858.CD001250] ∗ Indicates the major publication for the study

ADDITIONAL TABLES

Table 1. Methodological quality assessment tool

Items and scores

A. Was the assigned treatment adequately concealed prior to allocation? Score 2 = method did not allow disclosure of assignment Score 1 = small but possible chance of disclosure of assignment or unclear Score 0 = quasi-randomised or open list/tables

Cochrane code (see Handbook): Clearly yes = A; Not sure = B; Clearly no = C

B. Were the outcomes of patients who withdrew described and included in the analysis (intention to treat)? Score 2 = withdrawals well described and accounted for in analysis Score 1 = withdrawals described and analysis not possible Score 0 = no mention, inadequate mention, or obvious differences and no adjustment

C. Were the outcome assessors blinded to treatment status? Score 2 = effective action taken to blind assessors Score 1 = small or moderate chance of unblinding of assessors Score 0 = not mentioned or not possible

D. Were the treatment and control group comparable at entry? Score 2 = good comparability of groups, or confounding adjusted for in analysis Score 1 = confounding small; mentioned but not adjusted for Score 0 = large potential for confounding, or not discussed.

E. Were the subjects blind to assignment status after allocation?

Score 2 = effective action taken to blind subjects Score 1 = small or moderate chance of unblinding of subjects Score 0 = not possible, or not mentioned (unless double-blind), or possible but not done

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) 5 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 1. Methodological quality assessment tool (Continued)

F. Were the treatment providers blind to assignment status? Score 2 = effective action taken to blind treatment providers Score 1 = small or moderate chance of unblinding of treatment providers Score 0 = not possible, or not mentioned (unless double-blind), or possible but not done

G. Were care programmes, other than the trial options, identical? Score 2 = care programmes clearly identical Score 1 = clear but trivial differences Score 0 = not mentioned or clear and important differences in care programmes

H. Were the inclusion and exclusion criteria clearly defined? Score 2 = clearly defined Score 1 = inadequately defined Score 0 = not defined

J. Were the outcome measures used clearly defined? Score 2 = clearly defined Score 1 = inadequately defined Score 0 = not defined

K. Were diagnostic tests used in outcome assessment clinically useful? Score 2 = optimal Score 1 = adequate Score 0 = not deﬁned, not adequate

L . Was the duration of surveillance active and clinically appropriate? Score 2 = optimal Score 1 = adequate Score 0 = not deﬁned, not adequate

APPENDICES

Appendix 1. Search strategy for MEDLINE

MEDLINE (OVID Web)

1. Elbow/ or Elbow Joint/ or elbow$.tw. 2. exp Tendinopathy/ or (tendinopath$ or epicondylit$ or tend#nos$ or impingement).tw. 3. Joint Instability/ or instability.tw. 4. Tendon Injuries/ or Tendons/ or Tendons, Para-Articular/ or (tendon$ adj3 (bicep$ or tricep$)).tw.

5. Collateral Ligaments/ or Ligaments, Articular/ or ligament$.tw. 6. Soft Tissue Injuries/ or (injur$ adj3 soft tissue$).tw. 7. Athletic Injuries/ 8. exp “Sprains and strains”/ or (sprain$ or strain$ or cumulative trauma).tw. 9. or/2-8 10. and/1,9 11. Tennis Elbow/ or ((golfer$ or tennis) adj elbow$).tw. 12. or/10-11 13. Ultrasonics/ or Ultrasonic Therapy/ or (ultrasound or ultrasonic$1).tw. 14. and/12-13 15. randomized controlled trial.pt. 16. controlled clinical trial.pt. 17. Randomized Controlled Trials/ 18. Random Allocation/ 19. Double Blind Method/ 20. Single Blind Method/ 21. or/15-20 22. Animals/ not Humans/ 23. 21 not 22 24. clinical trial.pt. 25. exp Clinical Trials/ 26. (clinic$ adj25 trial$).tw. 27. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).tw. 28. Placebos/ 29. placebo$.tw. 30. random$.tw. 31. Research Design/ 32. or/24-31 33. 32 not 22 34. 33 not 23 35. or/23,34 36. and/14,35

WHAT’S NEW

Date Event Description

22 September 2008 Amended Converted to new review format.

Therapeutic ultrasound for soft-tissue injuries of the elbow (Protocol) 7 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. HISTORY Protocol ﬁrst published: Issue 1, 2007

DECLARATIONSOFINTEREST None known.

SOURCES OF SUPPORT

Internal sources • The University of Auckland, New Zealand.

External sources • No sources of support supplied