Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care

NCT03472989 | Completed DMC

• 1 other identifier: 2017/1325
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether radial extracorporeal shockwave therapy (rESWT), sham- rESWT or standardised exercise program is more effective on change in heel pain than usual care in the treatment of plantar fasciopathy. The null hypothesis is: There is no difference between rESWT, sham- rESWT or standardised exercise program on change in heel pain (primary outcome) and functioning (secondary outcomes) compared to usual care in the treatment of plantar fasciopathy at 6 months follow-up (and secondary outcomes at the 12 months follow-up). Alternative hypothesis is: H1: There is a difference between rESWT and usual care on change in heel pain (and secondary outcomes) at the 6 months follow-up (and secondary outcomes at the 12 months follow-up). H2: There is a difference between sham-rESWT and usual care on change in heel pain (and secondary outcomes ) at 6 months follow-up (and secondary outcomes at the 12 months follow-up). H3: There is a difference between standardized exercise program and usual care on change in heel pain (and secondary outcomes) at 6 months follow- up (and secondary outcomes at the 12 months follow-up).

Conditions

Plantar Fascitis

Keywords

plantar fasciopathy; plantar fasciitis; radial extracorporeal shock wave therapy; sham- radial extracorporeal shock wave therapy; high-load strength training; foot orthosis

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS)

  Change in heel pain (during activity the last week ). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).

  6 months

Secondary Outcomes (5)

• Foot Functional Index, revised, short Version (FFI-RS)

  6 and 12 months

• RAND- 12

  6 and 12 months

• Numeric rating scale (NRS)

  6 and 12 months

• Numeric rating scale (NRS)

  12 months

• Patient Global Impression Of Change Scale (PGIC)

  6 and 12 months

Study Arms (4)

Radial extracorporeal shock wave

ACTIVE COMPARATOR

Active shock wave treatment. All patients will get standardized information and custom made foot orthosis.

Device: Radial extracorporeal shock wave

Sham-radial extracorporeal shock wave

SHAM COMPARATOR

Sham- shock wave treatment. All patients will get standardized information and custom made foot orthosis.

Device: Sham-radial extracorporeal shock wave

Standardized high-load exercise program

ACTIVE COMPARATOR

High-load exercise treatment. All patients will get standardized information and custom made foot orthosis.

Behavioral: Standardized high-load exercise program

Usual care

ACTIVE COMPARATOR

Only standardized information and custom made foot orthosis

Behavioral: Usual care

Interventions

Radial extracorporeal shock wave DEVICE

Patients will receive treatment once a week for 3 weeks. Treatment will be administered by using the rESWT device named Swiss DolorClast (EMS). 2000 impulses are implied via the power hand piece to the area of max tenderness at the insertion of the plantar fascia, with a pressure of 1.5-3 bars depending on what the patient tolerates. The treatments will be given by a trained physiotherapist at our Department. Patients will also receive standardized information at baseline, and will get custom made foot orthosis.

Radial extracorporeal shock wave

Sham-radial extracorporeal shock wave DEVICE

Patients will receive the same treatment as the patients in the group receiving real shock waves, but no real shock waves are conducted. The probe is similar in design, sound and shape. Patients will also receive standardized information at baseline, and will get custom made foot orthosis.

Sham-radial extracorporeal shock wave

Standardized high-load exercise program BEHAVIORAL

Patients will be instructed to do 2 exercises: "Unilateral heel raise" and "unilateral leg squat" three times a week for 12 weeks. The patients will have a total of 8 sessions supervised by a physiotherapist at our Department. Patients will also receive standardized information at baseline, and will get custom made foot orthosis.

Standardized high-load exercise program

Usual care BEHAVIORAL

Patients will get standardized information as in the other three intervention groups with information on pathogenesis, etiology and prognosis, and they will get custom made foot orthosis

Usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain with duration \> 3 months localized in the proximal insertion of the plantar fascia on the medial calcaneal tuberosity.
• Only patients with reported pain NRS 3 or more at activity at baseline, will be included in the trial.
• Tenderness to palpation corresponding to the painful area.
• Be residents of Norway, understand oral and written Norwegian.

You may not qualify if:

• Treatment with radial extracorporeal shock wave therapy the last 3 months.
• Spondylarthropathy or rheumatoid arthritis.
• Plantar fibromatosis.
• Tarsal tunnel syndrome.
• Polyneuropathy.
• Previous surgery with remaining osteosynthesis material in the foot or ankle.
• Contraindications for shock wave therapy ( use of anticoagulant drugs, pregnancy, bleeding disorders, epilepsy or pacemaker)

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, 0450, Norway

Location

Related Publications (18)

• Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009 Jun;17(2):100-4. doi: 10.1097/JSA.0b013e3181a3d60e.

  PMID: 19440137 BACKGROUND

• 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 Apr;96(15):e6621. doi: 10.1097/MD.0000000000006621.

  PMID: 28403111 BACKGROUND

• Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. 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 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.

  PMID: 25145882 BACKGROUND

• Landorf KB. Plantar heel pain and plantar fasciitis. BMJ Clin Evid. 2015 Nov 25;2015:1111.

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• Gill LH. Plantar Fasciitis: Diagnosis and Conservative Management. J Am Acad Orthop Surg. 1997 Mar;5(2):109-117. doi: 10.5435/00124635-199703000-00006.

  PMID: 10797213 BACKGROUND

• 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 May;31(5):391-7. doi: 10.3113/FAI.2010.0391.

  PMID: 20460065 BACKGROUND

• Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L Jr, Weil L Sr, Russlies M, Stienstra J, Scurran B, Fedder K, Diehl P, Lohrer H, Henne M, Gollwitzer H. 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 Nov;36(11):2100-9. doi: 10.1177/0363546508324176. Epub 2008 Oct 1.

  PMID: 18832341 BACKGROUND

• 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 Jul;65(3):144-151. doi: 10.1016/j.jphys.2019.05.011. Epub 2019 Jun 13.

  PMID: 31204294 BACKGROUND

• 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 Aug;52(16):1040-1046. doi: 10.1136/bjsports-2017-097892. Epub 2018 Mar 19.

  PMID: 29555795 BACKGROUND

• 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 Mar;52(5):322-328. doi: 10.1136/bjsports-2016-097355. Epub 2017 Sep 21.

  PMID: 28935689 BACKGROUND

• Frisaldi E, Shaibani A, Benedetti F. Why We should Assess Patients' Expectations in Clinical Trials. Pain Ther. 2017 Jun;6(1):107-110. doi: 10.1007/s40122-017-0071-8. Epub 2017 May 5.

  PMID: 28477082 BACKGROUND

• 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 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.

  PMID: 23369667 BACKGROUND

• Johnson JA, Maddigan SL. Performance of the RAND-12 and SF-12 summary scores in type 2 diabetes. Qual Life Res. 2004 Mar;13(2):449-56. doi: 10.1023/B:QURE.0000018494.72748.cf.

  PMID: 15085917 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

• Roe C, Heide M, Soberg HL, Brunborg C, Hoksrud AF, Myhre K, Brox JI, Mork M. One-Year Trajectory of Pain, Function, and Health-Related Quality of Life in Patients With Plantar Fasciopathy. J Foot Ankle Res. 2025 Sep;18(3):e70067. doi: 10.1002/jfa2.70067.

  PMID: 40671207 DERIVED

• Mork M, Soberg HL, Heide M, Hoksrud AF, Groven KS, Brunborg C, Roe C. Predictors for pain and functioning in patients with plantar fasciopathy one year after inclusion in a treatment trial in specialist care. BMC Musculoskelet Disord. 2024 Dec 20;25(1):1049. doi: 10.1186/s12891-024-08187-2.

  PMID: 39702178 DERIVED

• Heide M, Roe C, Mork M, Myhre K, Brunborg C, Brox JI, Hoksrud AF. Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, randomised, sham-controlled trial. Br J Sports Med. 2024 Jul 31;58(16):910-918. doi: 10.1136/bjsports-2024-108139.

  PMID: 38904119 DERIVED

• Heide M, Mork M, Roe C, Brox JI, Fenne Hoksrud A. 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. Trials. 2020 Jun 29;21(1):589. doi: 10.1186/s13063-020-04510-z.

  PMID: 32600386 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Aasne Fenne Hoksrud, MD, PhD

  Oslo University hospital, Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients who receive rESWT or sham-rESWT will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Participants will be randomly assigned to one of the four intervention groups in parallell for the duration of the study.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: March 21, 2018
• Primary Completion: September 7, 2022
• Study Completion: February 22, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

NO (1)