A Comparison of ThermaWedge™ Device and Achilles Tendon Stretching for the Treatment of Plantar Fasciopathy

Study Overview
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Brief Summary
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The investigators will compare Achilles tendon stretching with a new product called a ThermaWedge™ device, a foam wedge designed to help with certain foot stretches and exercises, in the treatment of chronic plantar fasciopathy. There will be 2 groups each of 25 - 30 participants who have chronic plantar fasciopathy, which is a common cause of foot pain. Exercises will be done for 6 weeks and then each group will do the other exercise protocol for another 6 weeks. Participants will fill out the Foot and Ankle Disability Index scale and numerical analog pain scale and the Global Rating of Change Scale prior to any treatment, weekly during treatment and post treatment. The investigators' hypothesis is that use of the ThermaWedge™ device will result in decreased pain and disability when compared to achilles tendon stretching.

Official Title
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A Comparison of ThermaWedge™ Device and Achilles Tendon Stretching for the Treatment of Plantar Fasciopathy

Conditions
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Plantar Fasciitis, Plantar Fasciopathy

Intervention / Treatment
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* Device: ThermaWedge TM
* Other: Achilles Tendon Stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of plantar fasciopathy which has persisted (chronic) for at least 12 months. participants need to be able to understand simple instructions about the stretches which will likely include both verbal instructions and pictures and participants need to be able to do all the necessary exercises. Participants must have current British Columbia (BC) Medical Service Plan (MSP) health coverage so that if they become injured, they are covered medically. Participants must be able to fill out surveys online. Participants must also pass a clinical screen where a senior medical student or a physiotherapist, Scott Fraser, will assess the patient for for plantar fasciopathy/fasciitis. Exclusion Criteria: Previous ankle or foot trauma or surgery duration of pain of less than 12 months, those receiving adjuvant treatment such as injections during the time of the study, those who are unable to do the necessary exercises required in the study Those who do not have current BC MSP health insurance coverage.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Achilles Tendon Stretching<br>This is the arm of participants who will first be assigned to perform 6 weeks of achilles tendon stretching as demonstrated in the protocol. As this is a crossover design study, this arm will then switch to 6 weeks of ThermaWedge TM stretching. | Device: ThermaWedge TM<br>* ThermaWedge TM is a foam wedge device that is designed to be used in the treatment of plantar fasciopathy.<br>Other: Achilles Tendon Stretching<br>* Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.<br>|
| Experimental: ThermaWedge TM<br>This is the arm of participants who will first be assigned to perform 6 weeks of ThermaWedge TM stretching as demonstrated in the protocol. As this is a crossover design study this arm will then switch to 6 weeks of Achilles Tendon Stretching | Device: ThermaWedge TM<br>* ThermaWedge TM is a foam wedge device that is designed to be used in the treatment of plantar fasciopathy.<br>Other: Achilles Tendon Stretching<br>* Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change Scale - assessing change in pain and function | This is a rating scale which allows participants to indicate the degree of change in pain/function that the participant has experienced since the start of the intervention | The participants will use the scale on day 1 of the study, at weeks 1, 2 ,3 ,4 ,5, 6, 7, 8, 9, 10, 11, and 12, as well as 6 and 12 weeks after the completion of the intervention | 
| Foot and Ankle Disability Index - assessing change in disability | This is a questionnaire that assesses the amount of pain and the level of functioning that patient is currently experiencing with respect to the foot and ankle. | The participants will use the scale on day 1 of the study, at weeks 1, 2 ,3 ,4 ,5, 6, 7, 8, 9, 10, 11, and 12, as well as 6 and 12 weeks after the completion of the intervention | 
| Numerical Rating Scale - assessing change in severity of pain | This is a rating scale on which patients will rate the severity of the worst pain they have experienced in the last week from 0-10. | The participants will use the scale on day 1 of the study, at weeks 1, 2 ,3 ,4 ,5, 6, 7, 8, 9, 10, 11, and 12, as well as 6 and 12 weeks after the completion of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ThermaWedge TM, stretches