Emerging Therapies for Heel Pain – What Works? Jason R. Miller, DPM, FACFAS, FAPWCA Director- Pennsylvania Intensive Lower Extremity Fellowship Residency Director- Phoenixville Hospital PMSR/RRA Associate Professor- Adjunct Department of Surgery- Temple University School of Podiatric Medicine Premier Orthopaedics and Sports Medicine, Malvern PA Musculoskeletal-Plantar Fasciosis

• Widely called plantar fasciitis, but fasciosis is more appropriate 1 • Histopathology of PF of 50 patients who underwent surgery • Findings: fragmentation and degeneration of PF without inflammation • Corticosteroid injections? Lemont et al. say NO. • Over a lifetime, 10% of the general population will experience PF or plantar heel pain 2 • Peak age of incidence: 40-60 y.o • Risk factors: excessive running (or sudden increase), occupational (prolonged standing), pes planus, ankle equnius, and obesity.

1. Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc 2003; 93: 234-237 2. Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in management of plantar feel pain: a randomized control trial. Foot (Edinburg, Scotland) 2014;24(2):66-71. Other Plantar Fascia related pathology

• Plantar fascia rupture • Hx of chronic PF, pes planus • Acute pain and ecchymosis • Plantar fibromatosis • non-malignant thickening of PF

1. Al Kline. Plantar fascial rupture in the foot: a case report. The Foot and Ankle Online Journal 2009;2(5):4. Musculoskeletal-Fat pad atrophy

• Heel fat pad absorbs about 20- 25% of the contact force at heel strike. • Risk factors: over age 40, obesity, excessive heel injections • Thinning of calcaneal fat pad • Less shock absorbency with loss of water/collagen/elastic tissue

1. Morag E, Lemmon DR, Cavangh PR. What role does plantar soft tissue stiffness play in determining peak pressure under the heel? Gait Posture . 1997;5:164 . PF vs FPA

• Retrospectively studied 113 PF subjects, 37 FPA subjects, and 23 with both • Most common characteristics of each are compared below

Plantar Fasciosis Fat Pad Atrophy -Post-static dyskinesia -No PSD. Night pain -Relief after walking -Pain after long walk/standing -Unilateral -Bilateral -Often medial calcaneal tenderness -Often plantar-central tenderness

1. Yi TI, Lee GE, Seo IS, Huh WS, Yoon TH, Kim BR. Clinical characteristics of the causes of plantar heel pain. Ann Rehabil Med 2011;35:507-513. . MSK • Stress fracture • Tuning fork? • Lateral squeeze • Enthesopathy fracture • Sever’s disease • Child with heel pain, do NOT assume PF • OM MSK

• FHL tenosynovitis 1 • Dancers and long distance runners • Cavus foot • Uncompensated  poor shock absorption • Pronatory compensation  increase tensile stretch on PF

1. Romano N, Fischetti A, Migone S, Barbieri F, Pizzorni C, Garlaschi G, Cimmino MA. Plantar pain is not always fasciitis. Reumatismo 2017; 69 (4): 189-190. Metabolic and Arthritic

• Psoriatic arthritis 1 • About 25% of patients with skin manifestations had arthritic symptoms • Among those with PA, 54% reported heel pain. • Ankylosing spondylitis • Younger males with low back pain (SI fusion, bamboo spine) • Enthesopathy of medial calcaneal tubercle

1. Bezza,A, Niamane,R, et al. Involvement of the foot in patients with psoriatic arthritis. Joint Bone Spine, 2004;71(6):546-9. Metabolic and Arthritic • Reactive arthritis 1 • Heel pain is 2 nd most common presenting symptom (44% in study group). “Lover’s Heel” • Tetrad: conjunctivitis, urethritis, arthritis and mucocutaneous lesions (Keratoderma blennorrhagicum ) • Inflammatory bowel disease 2 • Crohn’s and Ulcerative Colitis • Pain in heel and joints (especially knee) often present before GI symptoms

1. Prakash,S, Bansal,R, et al. Immunological studies in seronegative spondyloarthropathies. British Journal Rheumatology, 1983, 22(3) 2. Veys,EM, Mielants,H. Enteropathic arthritis. Current Opinion Rheumatology. 1993,5(4):454-60. Metabolic and Arthritic • Rheumatoid arthritis 1 • Joints are affected most in foot, but 21% of study patients had daily heel pain. • Rheumatoid nodules in calcaneus  heel pain • Juvenile rheumatoid arthritis 2 • 319 patients (7-12 y.o). 95% had limp, and 95% had heel pain • Limp alone  quick diagnosis of JRA • Limp with heel pain  took 2x as long to make diagnosis • SLE: heel pain in immediate post-pubescent females

1. Thomas, WH. Rheumatoid arthritis of the ankle and foot. In: R.R. Cooper (Ed.)AAOS Instructional course lectures. Vol.28. CV Mosby, St. Louis; 1979:325- 336. 2. Shiff, NJ, Lix,LM, et al. Chronic inflammatory arthritis prevalence estimates for children and adolescents in three Canadian provinces. Rheumatol Int. 2015 Feb;35(2):345-350. Other Metabolic and Arthritic Causes • Gout • CPPD (pseduogout) • Hyperparathryoidism (Brown tumor) • Hemochromatosis • CREST • Osteoporosis • Paget’s disease of bone • Diffuse idiopathic skeletal hyperostosis Neurological • Tarsal tunnel syndrome • Tibial entrapment: post-op scarring, varicosities, soft tissue masses, overpronation • entrapment • Neuro heel pain: Tinel’s. Burning/radiating. Pain at rest. • Baxter’s • 1st branch of • Pain worsens with ambulation • EMG demonstrates obstructive signal • Nerve to Abductor digiti minimi • Can the patient abduct his/her 5 th toe? Neurological • Lumbar • L4-S1 (foraminal stenosis, disc herniation) • Straight leg raise + • Piriformis syndrome • impingement at piriformis muscle Peripheral neuropathies • Toxins (Lead, Arsenic, Mercury) • DM • HIV • Alcohol • Endocrine (hypothyroid) • Nutritional (Vit B12, B6) • Gullian-Barre • Recurrence of GB • Amylodosis • Porphyria • Infection (Syphilis, TB, Leprosy, Lyme disease) • Sarcoidosis • Tumor/Trauma Vascular • Isolated heel pain secondary to arterial infarct is RARE Bone Tumors: benign • Unicameral bone cyst • Fallen fragment sign, painful pathological fracture • Aneursymal bone cyst • Generally painful • Intraosseous lipoma • Osteochondroma • Osteoid Osteoma • Pain at night, relieved by aspirin • Osteoblastoma • “large osteoid osteoma” pain not relieved by aspirin Bone Tumors • Osteosarcoma • Children, and adults with Paget’s • Chondrosarcoma • Adults over 40 • Ewing’s Sarcoma Standard Conservative Treatment Options

• PT/Soft tissue mobilization • Iontophoresis • Orthotics • Steroid injection • Low Dye taping • Cam boot • Night splints Newer Alternative Treatment Options

• Platelet-rich plasma (PRP) • Centrifuged concentrate platelet levels  induce cell growth and tissue healing • Extracorporeal shock wave therapy (EPAT) FDA 2005 • Shock waves  Controlled microtrauma  stimulate healing & micro- vascularization • Dry Needle Technique (MTrP) • Needle (without steroid) at myofascial trigger point. • Low-level laser therapy (LLLT) • Visible or invisible laser at body surface  enhance mitochondrial activity  cell and microvascular proliferation  alleviate degeneration • External Radiotherapy • Safe, low doses of ionizing radiation (x-ray, Co-60) reduce inflammation  pain relief • Amnion/Stem Cell injections Surgical Treatment Options

• Open plantar fasciectomy • Endoscopic plantar fasciotomy • Percutaneous radiofrequency microdebridement therapy • Ultra-sound guided Percutaneous ultrasonic microdebridement ESWT/Focused Shock Wave/Radial Shock Wave Meta Analysis • 9 studies involving 935 patients were included. • ESWT had higher improvement rates than the placebo group (OR 2.58, 95% confidence interval [CI] 1.97–3.39, P < .00001). • ESWT had markedly lower standardized mean difference than placebo, with heterogeneity observed (standardized mean difference 1.01, 95% CI −0.01 to 2.03, P = .05, I2 = 96%, P < .00001). • FSW and RSW therapies had greater therapeutic success in pain relief than the placebo group (OR 2.17, 95% CI 1.49–3.16, P < .0001; OR 4.63, 95% CI 1.30– 16.46, P = .02), but significant heterogeneity was observed in RSW therapy versus placebo ( I2 = 81%, P = .005)

Sun et al, Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis A meta-analysis of RCTs Medicine (Baltimore) . 2017 Apr; 96(15): e6621. Dry Needling (MTrP) • Dry needling showed statistically significant 1 reduction in plantar heel pain (VAS) vs sham needling (placebo in blinded study) at 12 week f/u • 1 treatment per week, 6 weeks. • Compared to steroid injections 2. N= 66 • Steroid injections reduced pain more rapidly (first 3 weeks) • Dry needling reduced pain in long term (1 year follow-up)

1. Cotchett MP, Muneanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized control trail. Physical therapy 2014;94(8):1083-1094 2. Rastegar S, Mahdavi SB, Hoseinzadeh B, Badiei S. Comparison of dry needling and steroid injection in the treatment of plantar fasciitis: a single-blinded randomized control trial. International Orthopaedics (SICOT) 2018;42:109-116. Dry Needling Meta Analysis • Extensive literature search yielded 1,941 articles, of which only seven RCTs met the inclusion criteria and were included in the meta- analysis. • The pooled results showed that MTrP needling significantly reduced the VAS score (WMD =−15.50, 95% CI: −19.48, −11.53; P<0.001) compared with control • Similar success rate for pain with control (risk ratio [RR] =1.15, 95% CI: 0.87, 1.51; P=0.320). • Moreover, MTrP needling was associated with a similar incidence of adverse events with control (RR =1.89, 95% CI: 0.38, 9.39; P=0.438)

Chunhui et al Effectiveness of trigger point dry needling for plantar heel pain: a meta-analysis of seven randomized controlled trials J Pain Res . 2017; 10: 1933–1942. PRP ONLY Study • A prospective study by Ragab et al evaluated 25 patients with chronic plantar fasciitis (mean age, 44 years) • All patients were assessed for pain on the VAS before and after injection. • The thickness of the PF was measured by US before injection and at each post injection follow-up visit (mean follow-up, 10.3 months). Average pre injection pain was 9.1 on the VAS (range, 8-10). • Before injection, 72% of patients had severe limitation of activities, and 28% of patients had moderate limitation of activities. • Average post injection pain in this study was 1.6 on the VAS. 22 patients (88%) were completely satisfied, two (8%) were satisfied with reservations, and one (4%) was unsatisfied. • 15 patients (60%) had no functional limitations post injection, and eight (32%) had minimal functional limitations. • 2 patients (8%) had moderate functional limitations post injection. • US showed significant changes not only in thickness but also in the signal intensity of the plantar fascia after injection. • None of these patients experienced any complications from PRP injection at the end of the follow-up period. PRP in the Office?

• Double-blind study, patients were divided randomly into 3 groups: PRP, corticosteroid injection, placebo. • Pts were assessed with VAS and with the AOFAS Ankle and Hindfoot score before injection, at 3 weeks, and at 3-month follow-up. • Mean VAS in the PRP and corticosteroid groups decreased from 7.44 and 7.72 pre- injection to 2.52 and 3.64 at final follow-up, respectively. • Mean AOFAS score in the platelet-rich plasma and corticosteroid groups improved from 51.56 and 55.72 pre-injection to 88.24 and 81.32 at final follow-up, respectively. • There was a significant improvement in VAS and AOFAS score in the PRP and corticosteroid groups at 3 weeks and at 3-month follow-up. • PRP injection is as effective as or more effective than corticosteroid injection in treating chronic plantar fasciitis

Chronic Plantar Fasciitis: Effect of Platelet-Rich Plasma, Corticosteroid, and Placebo Pankaj Mahindra, MS; Mohammad Yamin, MS; Harpal S. Selhi, MS; Sonia Singla, MD; Ashwani Soni, MS Orthopedics. 2016;39(2):e285-e289 PRP VS STEROID INJECTIONS

• Meta-analysis of 9 RCT (n=430) comparing the two • No significant differences in pain (VAS) after 4 or 12 weeks • After 24 weeks, PRP exhibited better efficacy than steroids.

1. Yang WYY et al. Platelet-rich plasma as a treatment for plantar fasciitis: a meta-analysis of randomized control trials. Medicine 2017;96:44. Radiofrequency therapy Topaz procedure • Radio frequency waves cause microscopic “trauma” and ”burning holes” in the scar tissue. • Chronic  acute inflammation and healing RF nerve ablation • Electrode applied to most tender area  ablation of sensory nerve causing pain • 82 patients with up to 12 years of follow-up showed an 89% success rate. • Tx scar related heel pain, calcaneal bursitis, nerve entrapments and fat pad atrophy

1. Cozzarelli J, Sollitto RJ, Thapar J, Caponigro J. A 12-year long-term retrospective analysis of the use of radiofrequency nerve ablation for the treatment of neurogenic heel pain. Foot Ankle Spec . 2010; 3(6):338-46. Percutaneous Calcaneal Nerve Ablation - RFNA • No prospective randomized controlled studies comparing RFNA with other treatment modalities. • A prospective study by Erken et al reported their 2-year follow-up results of RFNA of the calcaneal branches of the inferior calcaneal nerve in 35 feet in 29 patients with chronic plantar heel pain associated with plantar fasciitis between 2008 and 2011. • All of the patients who were treated had been complaining of heel pain for >6 months and had failed conservative treatment. • The average VAS score of the feet was 9.2±1.9 before treatment, and the average AOFAS score was 66.9±8.1 (range, 44-80). • Post treatment, the average VAS scores were 0.5±1.3 at 1 month, 1.5±2.1 at 1 year, and 1.3±1.8 at 2 years. • The average AOFAS scores were 95.2±6.1 (range, 77-100) at 1 month, 93±7.5 (range, 71- 100) at 1-year follow-up, and 93.3±7.9 (range, 69-100) at 2-year follow-up. • At the 1- and 2-year follow-up, 85.7% of the patients rated their treatment as very successful or successful. Ultrasound guided percutaneous fasciotomy • Phacoemulsification: US energy emulsify and remove tissues by the TX1 working tip. • US guided: hypoechoic plantar fasciosis • TX1 working tip inserted through a stab incision, fascia is cut

1. Paul R. Langer. Two emerging technologies for Achilles tendinopathy and plantar fasciopathy. Clin Podiatr Med Surg 2015;32:183-193. Low-level laser therapy (LLLT) 635nm

Jastifer et al 2016 reported on a study of 30 patients who received LLLT and completed 12 months of follow-up. • Patients were treated 2x/wk for 3 weeks for a total of six treatments. • Patients demonstrated a mean improvement in heel pain VAS from 67.8 of 100 at baseline to 6.9 of 100 at the 12-month follow-up period. • Total FFI score improved from a mean of 106.2 at baseline to 32.3 at 12 months post procedure. Low-level laser therapy (LLLT)

Macias et al JFAS 2015 Level 1 • 69 subjects were enrolled in a placebo-controlled, randomized, double- blind, multicenter study • Pts treated 2x/wk for 3 weeks for a total of 6 treatments and were evaluated at 5 separate time points: before the procedure and at weeks 1, 2, 3, 6, and 8 • VAS and MSK US were used to evaluate and FFI • A mean improvement in heel pain with a VAS score of 29.6 ± 24.9 compared with the placebo subjects, who reported a mean improvement of 5.4 ± 16.0, a statistically significant difference ( p < .001) External Radiotherapy

• Prospective, randomized trial of a total of 66 pts, with evaluation every 6 weeks until 12-months post treatment. • Four patients were secondarily excluded after the trial began; 29 patients received a standard dose regimen, and the remaining 33 patients received a low dose of radiation therapy. • The standard dose patients were treated with a total dose of 6.0 Gy, applied in 6 single fractions of 1.0 Gy twice weekly on non-consecutive days. • The low dose arm received 0.6 Gy, applied in 6 single fractions of 0.1 Gy twice weekly on non-consecutive days. • The results of this study demonstrated that up to 80% of standard dose patients experienced complete pain relief, and pain relief remained constant or even improved for up to 64% of the study participants during the follow-up period of 48 weeks post-treatment.

Niewald, et al, Randomized, Multicenter Trial on the Effect of Radiation Therapy on Plantar Fasciitis (Painful Heel Spur) Comparing a Standard Dose With a Very Low Dose: Mature Results After 12 Months' Follow-Up . International Journal of Radiation Oncology*Biology*Physics , 2012; DOI: 10.1016/j.ijrobp.2012.06.022

Amniotic membrane for PF • Multipotent allograft of live human cells to treat chronic PF or tendon injury • Amnion vs steroid injection 1 Level 1 study • 14 steroid vs 9 amnion • 1 injection initially, option for 2 nd at 6 week f/u, and final 12 week f/u • Primary outcome measure: Foot Health Status Questionnaire (FHSQ). • Secondary outcome measurements: Visual Analog Scale (VAS) and verbally reported percentage improvement • The majority of outcome measurements showed no statistical difference between groups. • Has potential to reduce pain in PF and Achilles tendinitis as well 2 1. Hanselman AE , Tidwell JE , Santrock RD . Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study. Foot Ankle Int. 2015 Feb;36(2):151-8 Conclusions

• Newer or Alternative treatments may provide the same or better outcomes when compared with traditional modalities. • More robust, prospective studies are needed • Hopefully, this will inspire those studies or at provoke thought into how we currently treat this exceedingly prevalent condition.

References • Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc 2003; 93: 234-237. • Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in management of plantar feel pain: a randomized control trial. Foot (Edinburg, Scotland) 2014;24(2):66- 71. • Al Kline. Plantar fascial rupture in the foot: a case report. The Foot and Ankle Online Journal 2009;2(5):4. • Morag E, Lemmon DR, Cavangh PR. What role does plantar soft tissue stiffness play in determining peak pressure under the heel? Gait Posture . 1997;5:164 . • Yi TI, Lee GE, Seo IS, Huh WS, Yoon TH, Kim BR. Clinical characteristics of the causes of plantar heel pain. Ann Rehabil Med 2011;35:507-513. . • Romano N, Fischetti A, Migone S, Barbieri F, Pizzorni C, Garlaschi G, Cimmino MA. Plantar pain is not always fasciitis. Reumatismo 2017; 69 (4): 189-190. • Cotchett MP, Muneanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized control trail. Physical therapy 2014;94(8):1083-1094 • Bezza,A, Niamane,R, et al. Involvement of the foot in patients with psoriatic arthritis. Joint Bone Spine, 2004;71(6):546-9. • Moorthy,LN, Peterson,MGE. Burden of childhood-onset arthritis. Pediatric Rheumatology, 2010,8(8:20). • Prakash,S, Bansal,R, et al. Immunological studies in seronegative spondyloarthropathies. British Journal Rheumatology, 1983, 22(3) • Veys,EM, Mielants,H. Enteropathic arthritis. Current Opinion Rheumatology. 1993,5(4):454-60. • Thomas, WH. Rheumatoid arthritis of the ankle and foot. In: R.R.Cooper (Ed.)AAOS Instructional course lectures. Vol.28. CV Mosby, St. Louis; 1979:325- 336. 1. Shiff, NJ, Lix,LM, et al. Chronic inflammatory arthritis prevalence estimates for children and adolescents in three Canadian provinces. Rheumatol Int. 2015 Feb;35(2):345-350. 2. Yang WYY et al. Platelet-rich plasma as a treatment for plantar fasciitis: a meta-analysis of randomized control trials. Medicine 2017;96:44. • Cozzarelli J, Sollitto RJ, Thapar J, Caponigro J. A 12-year long-term retrospective analysis of the use of radiofrequency nerve ablation for the treatment of neurogenic heel pain. Foot Ankle Spec . 2010; 3(6):338-46. • Paul R. Langer. Two emerging technologies for Achilles tendinopathy and plantar fasciopathy. Clin Podiatr Med Surg 2015;32:183-193. 1. Hanselman AE , Tidwell JE , Santrock RD . Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study. Foot Ankle Int. 2015 Feb;36(2):151-8 2. 2. https://www.hindawi.com/journals/jsm/2015/219896/