Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03472989
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Marte Heide, MD, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 21, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE March 21, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
Numeric rating scale (NRS) [ Time Frame: 6 months ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Numeric rating scale (NRS) [ Time Frame: 6 months ]
Change in heel pain (during activity the last week )
Change History Complete list of historical versions of study NCT03472989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
  • Foot Functional Index, revised, short Version (FFI-RS) [ Time Frame: 6 and 12 months ]
    Change in Foot Health status. Consists of 34 questions.
  • RAND- 12 [ Time Frame: 6 and 12 months ]
    Health related quality of life. 12 items.
  • Numeric rating scale (NRS) [ Time Frame: 6 and 12 months ]
    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).
  • Numeric rating scale (NRS) [ Time Frame: 12 months ]
    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).
  • Patient Global Impression Of Change Scale (PGIC) [ Time Frame: 6 and 12 months ]
    7-point scale ranging from "very much improved" to "very much worse"
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Foot Functional Index, revised, short Version (FFI-RS) [ Time Frame: 6 and 12 months ]
    Change in Foot Health status. Consists of 34 questions.
  • RAND- 12 [ Time Frame: 6 and 12 months ]
    Health related quality of life. 12 items.
  • Ultrasound scanning thickness measure [ Time Frame: 6 and 12 months ]
    Thickness in millimeters, at the insertion of the fascia to calcaneus
  • Ultrasound findings: hypoechoic changes [ Time Frame: 6 and 12 months ]
    Presence or not of hypoechoic changes
  • Ultrasound findings: Vascularisation [ Time Frame: 6 and 12 months ]
    Presence or not of vascularisation
  • Ultrasound findings: Calcification [ Time Frame: 6 and 12 months ]
    Presence or not of calcification
  • Numeric rating scale (NRS) [ Time Frame: 6 and 12 months ]
    Change in heel pain (in rest the last week)
  • Numeric rating scale (NRS) [ Time Frame: 12 months ]
    Change in heel pain (in activity the last week)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care
Official Title  ICMJE 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
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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
Masking Description:
The patients who receive rESWT or sham-rESWT will be blinded.
Primary Purpose: Treatment
Condition  ICMJE Plantar Fascitis
Intervention  ICMJE
  • Device: Radial extracorporeal shock wave

    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.

  • Device: Sham-radial extracorporeal shock wave

    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.

  • Behavioral: Standardized high-load exercise program

    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.

  • Behavioral: Usual care
    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
Study Arms  ICMJE
  • Active Comparator: Radial extracorporeal shock wave
    Active shock wave treatment. All patients will get standardized information and custom made foot orthosis.
    Intervention: Device: Radial extracorporeal shock wave
  • Sham Comparator: Sham-radial extracorporeal shock wave
    Sham- shock wave treatment. All patients will get standardized information and custom made foot orthosis.
    Intervention: Device: Sham-radial extracorporeal shock wave
  • Active Comparator: Standardized high-load exercise program
    High-load exercise treatment. All patients will get standardized information and custom made foot orthosis.
    Intervention: Behavioral: Standardized high-load exercise program
  • Active Comparator: Usual care
    Only standardized information and custom made foot orthosis
    Intervention: Behavioral: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marte Heide, MD +4790125116 marte.heide@medisin.uio.no
Contact: Aasne Fenne Hoksrud, MD, PhD +4747417204 aahoks@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03472989
Other Study ID Numbers  ICMJE 2017/1325
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marte Heide, MD, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aasne Fenne Hoksrud, MD, PhD Oslo University hospital, Department of Physical Medicine and Rehabilitation
PRS Account Oslo University Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP