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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518841
Enrollment
60
Registered
2015-08-10
Start date
2015-08-31
Completion date
2018-06-30
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciitis, Plantar Fasciopathy

Keywords

ThermaWedge TM, stretches

Brief 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.

Interventions

DEVICEThermaWedge TM

ThermaWedge TM is a foam wedge device that is designed to be used in the treatment of plantar fasciopathy.

OTHERAchilles Tendon Stretching

Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Global Rating of Change Scale - assessing change in pain and functionThe 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 interventionThis 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
Foot and Ankle Disability Index - assessing change in disabilityThe 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 interventionThis 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.
Numerical Rating Scale - assessing change in severity of painThe 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 interventionThis 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026