Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

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).
    

Detailed description: 
      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.
    

Intervention name(s): Radial extracorporeal shock wave; Sham-radial extracorporeal shock wave; Standardized high-load exercise program; Usual care
Intervention type(s): Device; Device; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of the four intervention groups in parallell for the duration of the study.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plantar fasciopathy; plantar fasciitis; radial extracorporeal shock wave therapy; sham- radial extracorporeal shock wave therapy; high-load strength training; foot orthosis