The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial

Marte Heide, Marianne Mørk, Cecilie Røe, Jens Ivar Brox, Aasne Fenne Hoksrud, Marte Heide, Marianne Mørk, Cecilie Røe, Jens Ivar Brox, Aasne Fenne Hoksrud

Abstract

Background: Plantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the evidence is questionable. There are few studies reporting the effect of exercise programs with high-load strength training, despite widespread use. The objective of this placebo-controlled, observer-blinded and partly patient blinded trial is to compare rESWT, sham-rESWT, standardised exercise programme and usual care for alleviating heel pain at 6 and 12 months follow-up.

Methods/design: A double-blind, randomised, sham-controlled trial is conducted at a hospital outpatient clinic of physical medicine and rehabilitation. Patients with chronic (> 3 months) pain due to plantar fasciopathy, aged 18 to 70 years old, are eligible for inclusion in the trial. Patients will be randomly allocated in 1:1 ratio to receive rESWT, sham-rESWT, standardised exercises or usual care. The sample size is estimated to 200 patients, 50 in each group. rESWT or sham-rESWT will be given once a week for 3 weeks. A physiotherapist will supervise the exercises, with a total of 8 sessions over 12 weeks. The patients in the usual care group will receive information, advice and foot orthosis only. All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician. The primary outcome measure is heel pain intensity during activity in the last week, using a numeric rating scale (NRS, 0 to 10) at the 6 months follow-up adjusted for baseline pain intensity. The secondary outcomes are at the 6- and 12-month follow-up and include Foot Functional Index Revised Short Version (FFI-RS), Patient Global Impression of Change Scale (7-point Likert scale), RAND-12 Health Status Inventory (RAND-12), NRS during rest and NRS during activity (12 months). The patients receiving rESWT/sham-rESWT and the outcome assessor will be blinded to the group assignment.

Discussion: This trial is designed in order to provide results important for future clinical practice.

Trial registration: ClinicalTrials.gov NCT03472989 . Registered on 14 March 2018.

Keywords: Foot orthosis; High-load strength training; Plantar fasciitis; Plantar fasciopathy; Radial extracorporeal shock wave therapy; Randomised controlled trial; Sham-radial extracorporeal shock wave therapy.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

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Flowchart

References

    1. Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009;17(2):100–104.
    1. Irving DB, Cook JL, Young MA, Menz HB. Impact of chronic plantar heel pain on health-related quality of life. J Am Podiatr Med Assoc. 2008;98(4):283–289.
    1. Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003;93(3):234–237.
    1. Landorf KB. Plantar heel pain and plantar fasciitis. BMJ Clin Evid. 2015;2015:1111.
    1. Singh D, Angel J, Bentley G, Trevino SG. Fortnightly review. Plantar fasciitis. BMJ (Clinical research ed) 1997;315(7101):172–175.
    1. Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004;350(21):2159–2166.
    1. Hansen L, Krogh TP, Ellingsen T, Bolvig L, Fredberg U. Long-term prognosis of plantar fasciitis: a 5- to 15-year follow-up study of 174 patients with ultrasound examination. Orthop J Sports Med. 2018;6(3):2325967118757983.
    1. Orchard J. Plantar fasciitis. BMJ (Clinical research ed) 2012;345:e6603.
    1. Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ) 2010;39(5):227–231.
    1. Tahririan MA, Motififard M, Tahmasebi MN, Siavashi B. Plantar fasciitis. J Res Med Sci. 2012;17(8):799–804.
    1. Draghi F, Gitto S, Bortolotto C, Draghi AG, Ori Belometti G. Imaging of plantar fascia disorders: findings on plain radiography, ultrasound and magnetic resonance imaging. Insights Imaging. 2017;8(1):69–78.
    1. Irving DB, Cook JL, Menz HB. Factors associated with chronic plantar heel pain: a systematic review. J Sci Med Sport. 2006;9(1–2):11–22.
    1. van Leeuwen KD, Rogers J, Winzenberg T, van Middelkoop M. Higher body mass index is associated with plantar fasciopathy/‘plantar fasciitis’: systematic review and meta-analysis of various clinical and imaging risk factors. Br J Sports Med. 2016;50(16):972–981.
    1. Gill LH. Plantar fasciitis: diagnosis and conservative management. JAAOS. 1997;5(2):109–117.
    1. van der Worp H, van den Akker-Scheek I, van Schie H, Zwerver J. ESWT for tendinopathy: technology and clinical implications. Knee Surg Sports Traumatol Arthrosc. 2013;21(6):1451–1458.
    1. Sun J, Gao F, Wang Y, Sun W, Jiang B, Li Z. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: a meta-analysis of RCTs. Medicine (Baltimore) 2017;96(15):e6621.
    1. Storheim K, Gjersing L, Bølstad K, Risberg MA. Sjokkbølgebehandling- og trykkbølgebehandling ved kroniske muskel- og skjelettsmerter. Tidsskr Nor Legeforen. 2010;2010(Utgave 23):130:2360.
    1. Kuo YR, Wang CT, Wang FS, Chiang YC, Wang CJ. Extracorporeal shock-wave therapy enhanced wound healing via increasing topical blood perfusion and tissue regeneration in a rat model of STZ-induced diabetes. Wound Repair Regen. 2009;17(4):522–530.
    1. Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010;31(5):391–397.
    1. Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L, Jr, Weil L, Sr, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008;36(11):2100–2109.
    1. Ryan M, Hartwell J, Fraser S, Newsham-West R, Taunton J. Comparison of a physiotherapy program versus dexamethasone injections for plantar fasciopathy in prolonged standing workers: a randomized clinical trial. Clin J Sport Med. 2014;24(3):211–217.
    1. Kamonseki DH, Goncalves GA, Yi LC, Junior IL. Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: a randomized controlled single-blind clinical trial. Man Ther. 2016;23:76–82.
    1. Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, et al. High-load strength training improves outcome in patients with plantar fasciitis: a randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015;25(3):e292–e300.
    1. Malliaras P, Barton CJ, Reeves ND, Langberg H. Achilles and patellar tendinopathy loading programmes: a systematic review comparing clinical outcomes and identifying potential mechanisms for effectiveness. Sports Med (Auckland, NZ) 2013;43(4):267–286.
    1. Carlson RE, Fleming LL, Hutton WC. The biomechanical relationship between the tendoachilles, plantar fascia and metatarsophalangeal joint dorsiflexion angle. Foot Ankle Int. 2000;21(1):18–25.
    1. Riel H, Jensen MB, Olesen JL, Vicenzino B, Rathleff MS. Self-dosed and pre-determined progressive heavy-slow resistance training have similar effects in people with plantar fasciopathy: a randomised trial. J Physiother. 2019; 65(30):144–51.
    1. Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN. Considering usual medical care in clinical trial design. PLoS Med. 2009;6(9):e1000111.
    1. Rasenberg N, Riel H, Rathleff MS, Bierma-Zeinstra SMA, van Middelkoop M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018;52:1040–6.
    1. Whittaker GA, Munteanu SE, Menz HB, Tan JM, Rabusin CL, Landorf KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018;52(5):322–328.
    1. Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, et al. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009;19(6):790–802.
    1. Frisaldi E, Shaibani A, Benedetti F. Why we should assess patients’ expectations in clinical trials. Pain Ther. 2017;6(1):107–110.
    1. Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158.
    1. Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011;152(10):2399–2404.
    1. Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013;6(1):5.
    1. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25(24):3186–3191.
    1. Johnson JA, Maddigan SL. Performance of the RAND-12 and SF-12 summary scores in type 2 diabetes. Qual Life Res. 2004;13(2):449–456.
    1. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1–2):9–19.
    1. Juel NG, Faugli HP, Ludvigsen TC. Klinisk undersøkelse av bevegelsesapparatet. 1. Bergen: Fagbokforlaget; 2012. pp. 214–276.
    1. Krause DA, Cloud BA, Forster LA, Schrank JA, Hollman JH. Measurement of ankle dorsiflexion: a comparison of active and passive techniques in multiple positions. J Sport Rehabil. 2011;20(3):333–344.
    1. Hebert-Losier K, Newsham-West RJ, Schneiders AG, Sullivan SJ. Raising the standards of the calf-raise test: a systematic review. J Sci Med Sport. 2009;12(6):594–602.
    1. Hoksrud A, Ohberg L, Alfredson H, Bahr R. Color Doppler ultrasound findings in patellar tendinopathy (jumper’s knee) Am J Sports Med. 2008;36(9):1813–1820.
    1. Harrel FE. Regression modeling strategies. With applications to linear models, logistic regression, and survival analysis. 2nd ed. New York: Springer International Publishing; 2015.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ (Clinical research ed) 2013;346:e7586.
    1. Rompe JD, Furia J, Weil L, Maffulli N. Shock wave therapy for chronic plantar fasciopathy. Br Med Bull. 2007;81–82:183–208.
    1. Armitage P. The role of randomization in clinical trials. Stat Med. 1982;1(4):345–352.

Source: PubMed

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