Top

Trials

Published in:

Open Access 01-12-2022 | Study protocol

Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial

Authors: Stefan Møller, Henrik Riel, Jens Wester, Ane Simony, Bjarke Viberg, Carsten Jensen

Published in: Trials | Issue 1/2022

Abstract

Background

Plantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally considered self-limiting with persistent symptoms that often last for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. Heavy-slow resistance training and radiofrequency microtenotomy for the treatment of plantar fasciopathy have shown potentially positive effects on short- and long-term outcomes (> 3 months). However, the effect of heavy-slow resistance training compared with a radiofrequency microtenotomy treatment is currently unknown. This trial compares the efficacy of heavy-slow resistance training and radiofrequency microtenotomy treatment with supplemental standardized patient education and heel inserts in improving the Foot Health Status Questionnaire pain score after 6 months in patients with plantar fasciopathy.

Methods

In this randomized superiority trial, we will recruit 70 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of two groups: (1) heavy-slow resistance training, patient education and a heel insert (n = 35), and (2) radiofrequency microtenotomy treatment, patient education and a heel insert (n = 35). All participants will be followed for 1 year, with the 6-month follow-up considered the primary endpoint. The primary outcome is the Foot Health Status Questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a Global Perceived Effect scale, the physical activity level, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment.

Discussion

By comparing the two treatment options, we should be able to answer if radiofrequency microtenotomy compared with heavy-slow resistance training is superior in patients with plantar fasciopathy.

Trial registration

ClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.

Available only for authorised users

Dunn JE, Link CL, Felson DT, Crincoli MG, Keysor JJ, McKinlay JB. Prevalence of foot and ankle conditions in a multiethnic community sample of older adults. Am J Epidemiol. 2004;159(5):491–8.PubMedCrossRef

Hill CL, Gill TK, Menz HB, Taylor AW. Prevalence and correlates of foot pain in a population-based study: the North West Adelaide Health Study. J Foot Ankle Res. 2008;1(1):2.PubMedPubMedCentralCrossRef

Riel H, Lindstrom CF, Rathleff MS, Jensen MB, Olesen JL. Prevalence and incidence rate of lower-extremity tendinopathies in a Danish general practice: a registry-based study. BMC Musculoskelet Disord. 2019;20(1):239.PubMedPubMedCentralCrossRef

Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010;39(5):227–31.

Buchbinder R. Plantar fasciitis. N Engl J Med. 2004;350(21):2159–66+225.PubMedCrossRef

Singh D, Angel J, Bentley G, Trevino SG. Fortnightly review. Plantar fasciitis. BMJ (Clinical research ed). 1997;315(7101):172–5.CrossRef

Cotchett M, Munteanu SE, Landorf KB. Depression, anxiety, and stress in people with and without plantar heel pain. Foot Ankle Int. 2016;37(8):816–21.PubMedCrossRef

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):283–9.PubMedCrossRef

DiGiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, et al. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis: a prospective clinical trial with two-year follow-up. J Bone Joint Surg - Series A. 2006;88(8):1775–81.CrossRef

10.

Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, et al. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg - Series A. 2010;92(15):2514–22.CrossRef

11.

Wolgin M, Cook C, Graham C, Mauldin D. Conservative treatment of plantar heel pain: long-term follow-up. Foot Ankle Int. 1994;15(3):97–102.PubMedCrossRef

12.

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. Orthopaedic. J Sports Med. 2018;6(3).

13.

Morrissey D, Cotchett M, Said J, Bari A, Prior T, Griffiths IB, et al. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021;55(19):1106.PubMedCrossRef

14.

Salvioli S, Guidi M, Marcotulli G. The effectiveness of conservative, non-pharmacological treatment, of plantar heel pain: a systematic review with meta-analysis. Foot (Edinb). 2017;33:57–67.CrossRef

15.

Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, et al. Heel pain—plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014;44(11):A1–A33.PubMedCrossRef

16.

Babatunde OO, Legha A, Littlewood C, Chesterton LS, Thomas MJ, Menz HB, et al. Comparative effectiveness of treatment options for plantar heel pain: a systematic review with network meta-analysis. Br J Sports Med. 2019;53(3):182–94.PubMedCrossRef

17.

Beyer R, Kongsgaard M, Hougs Kjær B, Øhlenschlæger T, Kjær M, Magnusson SP. Heavy slow resistance versus eccentric training as treatment for Achilles tendinopathy: a randomized controlled trial. Am J Sports Med. 2015;43(7):1704–11.PubMedCrossRef

18.

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.PubMedCrossRef

19.

Malliaras P, Barton CJ, Reeves ND, Langberg H. Achilles and patellar tendinopathy loading programmes. Sports Med. 2013;43(4):267–86.PubMedCrossRef

20.

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 [with consumer summary]. Scand J Med Sci Sports. 2015;25(3):e292–300.PubMedCrossRef

21.

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(3):144–51.PubMedCrossRef

22.

Molund M, Husebye EE, Hellesnes J, Nilsen F, Hvaal K. Proximal medial gastrocnemius recession and stretching versus stretching as treatment of chronic plantar heel pain. Foot Ankle Int. 2018;39(12):1423–31.PubMedCrossRef

23.

Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009;17(2):100–4.PubMedCrossRef

24.

Wheeler P, Boyd K, Shipton M. Surgery for patients with recalcitrant plantar fasciitis: good results at short-, medium-, and long-term follow-up. Orthop J Sports Med. 2014;2(3):2325967114527901.PubMedPubMedCentralCrossRef

25.

Shah A, Best AJ, Rennie WJ. Percutaneous ultrasound-guided TOPAZ radiofrequency coblation: a novel coaxial technique for the treatment of recalcitrant plantar fasciitis-our experience. J Ultrasound Med. 2016;35(6):1325–31.PubMedCrossRef

26.

Tay KS, Ng YC, Singh IR, Chong KW. Open technique is more effective than percutaneous technique for TOPAZ radiofrequency coblation for plantar fasciitis. Foot Ankle Surg. 2012;18(4):287–92.PubMedCrossRef

27.

Chou AC, Ng SY, Su DH, Singh IR, Koo K. Radiofrequency microtenotomy is as effective as plantar fasciotomy in the treatment of recalcitrant plantar fasciitis. Foot Ankle Surg. 2016;22(4):270–3.PubMedCrossRef

28.

Sorensen MD, Hyer CF, Philbin TM. Percutaneous bipolar radiofrequency microdebridement for recalcitrant proximal plantar fasciosis. J Foot Ankle Surg. 2011;50(2):165–70.PubMedCrossRef

29.

Weil LS Sr, Weil L Jr, Benton-Weil W, Fridman R, Cain J. Percutaneous radiofrequency microfasciotomy for the treatment of plantar fasciosis. Tech Foot Ankle Surg. 2011;10(2):65–70.CrossRef

30.

Weil L Jr, Glover JP, Weil LS Sr. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. 2008;1(1):13–8.PubMedCrossRef

31.

Hormozi J, Lee S, Hong DK. Minimal invasive percutaneous bipolar radiofrequency for plantar fasciotomy: a retrospective study. J Foot Ankle Surg. 2011;50(3):283–6.PubMedCrossRef

32.

Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010;16(4):174–7.PubMedCrossRef

33.

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.PubMedPubMedCentralCrossRef

34.

Landorf KB, Radford JA. Minimal important difference: values for the Foot Health Status Questionnaire, Foot Function Index and visual analogue scale. Foot. 2008;18:15–9.CrossRef

35.

McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324(7351):1448–51.PubMedPubMedCentralCrossRef

36.

Riel H, Vicenzino B, Olesen JL, Jensen MB, Ehlers LH, Rathleff MS. Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial). Trials. 2020;21(1):5. https://doi.org/10.1186/s13063-019-3977-0.

37.

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(16):1040–6.PubMedCrossRef

38.

Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010;363(4):331–42.PubMedCrossRef

39.

Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical therapy. Phys Ther. 1993;73(11):771–82 discussion 83-6.PubMedCrossRef

40.

McCarthy CJ, Mills PM, Pullen R, Richardson G, Hawkins N, Roberts CR, et al. Supplementation of a home-based exercise programme with a class-based programme for people with osteoarthritis of the knees: a randomised controlled trial and health economic analysis. Health Technol Assess. 2004;8(46):iii-iv 1-61.CrossRef

41.

Mikolaizak AS, Lord SR, Tiedemann A, Simpson P, Caplan G, Bendall JC, et al. Adherence to a multifactorial fall prevention program following paramedic care: predictors and impact on falls and health service use. Results from an RCT a priori subgroup analysis. Australas J Ageing. 2018;37(1):54–61.PubMedCrossRef

42.

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.PubMedCrossRef

43.

Mann JB, Thyfault JP, Ivey PA, Sayers SP. The effect of autoregulatory progressive resistance exercise vs. linear periodization on strength improvement in college athletes. J Strength Cond Res. 2010;24(7):1718–23.PubMedCrossRef

44.

Riel H, Jensen MB, Olesen JL, Rathleff MS. Translation and cultural adaption of a Danish version of the Foot Health Status Questionnaire for individuals with plantar heel pain. Foot. 2019; In Press, accepted manuscript.

45.

Riskowski JL, Hagedorn TJ, Hannan MT. Measures of foot function, foot health, and foot pain: American Academy of Orthopedic Surgeons Lower Limb Outcomes Assessment: Foot and Ankle Module (AAOS-FAM), Bristol Foot Score (BFS), Revised Foot Function Index (FFI-R), Foot Health Status Questionnaire (FHSQ), Manchester Foot Pain and Disability Index (MFPDI), Podiatric Health Questionnaire (PHQ), and Rowan Foot Pain Assessment (ROFPAQ). Arthritis Care Res. 2011;63:S229–39. https://doi.org/10.1002/acr.20554.CrossRef

46.

Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63(7):760–6 e1.PubMedCrossRef

47.

Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997;24(4):799–802.PubMed

48.

Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006;9(6):755–62.PubMedCrossRef

49.

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.PubMedCrossRef

50.

Kvien TK, Heiberg T, Hagen KB. Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean? Ann Rheum Dis. 2007;66(Suppl 3):iii40–1.PubMedPubMedCentral

51.

Sabir N, Demirlenk S, Yagci B, Karabulut N, Cubukcu S. Clinical utility of sonography in diagnosing plantar fasciitis. J Ultrasound Med. 2005;24(8):1041–8.PubMedCrossRef

52.

Kane D, Greaney T, Shanahan M, Duffy G, Bresnihan B, Gibney R, et al. The role of ultrasonography in the diagnosis and management of idiopathic plantar fasciitis. Rheumatology (Oxford). 2001;40(9):1002–8.CrossRef

53.

Sconfienza LM, Silvestri E, Orlandi D, Fabbro E, Ferrero G, Martini C, et al. Real-time sonoelastography of the plantar fascia: comparison between patients with plantar fasciitis and healthy control subjects. Radiology. 2013;267(1):195–200.PubMedCrossRef

54.

Rathleff MS, Moelgaard C, Lykkegaard OJ. Intra- and interobserver reliability of quantitative ultrasound measurement of the plantar fascia. J Clin Ultrasound. 2011;39(3):128–34.PubMedCrossRef

55.

McMillan AM, Landorf KB, Barrett JT, Menz HB, Bird AR. Diagnostic imaging for chronic plantar heel pain: a systematic review and meta-analysis. J Foot Ankle Res. 2009;2:32.PubMedPubMedCentralCrossRef

56.

Colberg RE, Ketchum M, Javer A, Drogosz M, Gomez M, Fleisig GS. Clinical outcomes of percutaneous plantar fasciotomy using microdebrider coblation wand. Foot Ankle Int. 2019;41(2):187–9.PubMedCrossRef

57.

Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003;93(3):234–7.PubMedCrossRef

58.

Oliva F, Piccirilli E, Tarantino U, Maffulli N. Percutaneous release of the plantar fascia. New surgical procedure. Muscles, Ligaments Tendons J. 2017;7:338–40.CrossRef

59.

Al Bagali MASM, Hashem F, Sager W. The effectiveness of radiofrequency-based percutaneous microtenotomy (TOPAZ) to treat refractory plantar fasciitis. Austin J Orthopade & Rheumatol. 2016;3(3):1039 ISSN: 2472-369X. 2016.

Title: Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial
Authors: Stefan Møller
Henrik Riel
Jens Wester
Ane Simony
Bjarke Viberg
Carsten Jensen
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06785-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Comparison of Buyang Huanwu granules and Naoxintong capsules in the treatment of stable angina pectoris: rationale and design of a randomized, blinded, multicentre clinical trial

ASEPTIC: primary antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis—study protocol for an interventional randomised controlled trial

ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial

Correction: G-CuP: the effect of a forced oral glucose intake on alcohol craving and mesolimbic cue reactivity in alcohol dependence—study protocol of a randomized, double-blind, placebo-controlled crossover study

Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention

Goal-directed therapy based on rScO2 monitoring in elderly patients with one-lung ventilation: a randomized trial on perioperative inflammation and postoperative delirium