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Completed

NCT Number: NCT02518841

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases Plantar Fasciopathy

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ThermaWedge TM

Device

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

Achilles Tendon Stretching

Other

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

Primary outcomes

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

    Time frame: 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

    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

  2. Foot and Ankle Disability Index - assessing change in disability

    Time frame: 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

    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.

  3. Numerical Rating Scale - assessing change in severity of pain

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2015
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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