CompletedNot Applicable

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

Canada60 participantsStarted 2015-08

Plain-language summary

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.

Who can participate

Age range

19 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global Rating of Change Scale - assessing change in pain and function

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT02518841

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06

View on ClinicalTrials.gov More Plantar Fasciitis trials

Plain-language summary

Who can participate

Age range

19 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Global Rating of Change Scale - assessing change in pain and function

Timeframe: 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

Timeframe: 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

Timeframe: 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