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

Study Overview
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Brief Summary
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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).

Detailed Description
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Plantar fasciopathy is a common cause of plantar heel pain, with reported lifetime prevalence up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that Radial Extracorporeal Shock Wave Therapy (rESWT) is effective, but a meta-analysis concluded that due to methological limitations the evidence is questioned. There are few studies reporting the effect on exercise programs with high-load strength training, despite widespread use. The usual care at our outpatient clinic is information on the pathogenesis, etiology and prognosis. We give advice on using proper footwear, including foot orthosis and to accept pain to a certain level during activity. To our knowledge there are no other previous trials comparing rESWT, sham-rESWT and exercises to usual care. This trial is designed in order to provide results important for future clinical practice. The patients who give their informed consent will be randomised into one of the four Groups; rESWT, sham-rESWT, standardized exercise or usual care. A computer generation randomisation schedule with blocks of 8, in a 1:1 ratio, will be performed by an external statistician and electronically concealed. All the patients regardless of group allocation will receive standardized information (oral and written) on the condition and get custom made foot orthosis made by an orthopedic technician at Sophies Minde AS. The patients are blinded for rESWT/sham-rESWT, whereas blinding of the exercise group and usual care group is not possible. To evaluate the blinding of the rESWT, the patients are asked after the last treatment whether they believe that they have received real rESWT, sham-rESWT or if they do not know. The patients will have follow-up at 3 months, 6 months and 12 months. The main outcome is change in heel pain (NRS) during activity at 6 months. Patient characteristics, anthropometric data and the duration of symptoms in the different groups will be registered at baseline, and presented as mean values (SD) for continuous variables or numbers (%) for categorical data. Pain and function scores will be presented as mean (SD). In addition to the two- group comparisons with t-tests, we will perform longitudinal data analysis and perform a mixed model analysis to compare differences between groups at follow- up with adjustment for scores at baseline and present mean differences (95% confidence intervals). We will perform analysis regarding secondary outcome as stated above. In addition we will apply multivariable logistic and linear regression analysis to identify predictive factors as demographics, clinical and ultrasound findings for primary and secondary outcomes. Model building will be done in a way that is appropriate for the given sample sizes, by restricting the number of potential predictive factors and considering shrinkage methods to stabilise predictions. Participants in the exercise group not attending 6 of 8 sessions with the physiotherapist or not completing 30 of 36 exercise sessions (3 sessions per week, 12 weeks) are regarded as non- adherence. In the rESWT and sham- rESWT group, participants not attending 2 of 3 sessions are regarded as non- adherence. They will be included in the intention- to- treat analysis. There will also be a separate intention-to- treat analysis with only adherent patients. There will be performed a study evaluating the validity, reliability and responsiveness on the Foot Functional Index Revised Short Form.

Official Title
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The Effectiveness of Radial Extracorporeal Shockwave Therapy (rESWT), Sham- rESWT, Standardised Exercise Program or Usual Care for Patients With Plantar Fasciopathy. Study Protocol for a Double-blind, Randomised Sham- Controlled Trial

Conditions
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Plantar Fascitis

Intervention / Treatment
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* Device: Radial extracorporeal shock wave
* Device: Sham-radial extracorporeal shock wave
* Behavioral: Standardized high-load exercise program
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of the four intervention groups in parallell for the duration of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial extracorporeal shock wave<br>Active shock wave treatment. All patients will get standardized information and custom made foot orthosis. | Device: Radial extracorporeal shock wave<br>* 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.<br>|
| Sham Comparator: Sham-radial extracorporeal shock wave<br>Sham- shock wave treatment. All patients will get standardized information and custom made foot orthosis. | Device: Sham-radial extracorporeal shock wave<br>* 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.<br>|
| Active Comparator: Standardized high-load exercise program<br>High-load exercise treatment. All patients will get standardized information and custom made foot orthosis. | Behavioral: Standardized high-load exercise program<br>* 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.<br>|
| Active Comparator: Usual care<br>Only standardized information and custom made foot orthosis | Behavioral: Usual care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Functional Index, revised, short Version (FFI-RS) | Change in Foot Health status. Consists of 34 questions. | 6 and 12 months | 
| RAND- 12 | Health related quality of life. 12 items. | 6 and 12 months | 
| Numeric rating scale (NRS) | Change in heel pain (in rest the last week). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain). | 6 and 12 months | 
| Numeric rating scale (NRS) | Change in heel pain (in activity the last week).Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain). | 12 months | 
| Patient Global Impression Of Change Scale (PGIC) | 7-point scale ranging from very much improved to very much worse | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantar fasciopathy, plantar fasciitis, radial extracorporeal shock wave therapy, sham- radial extracorporeal shock wave therapy, high-load strength training, foot orthosis