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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518841
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jack Taunton, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Plantar Fasciopathy Device: ThermaWedge TM Other: Achilles Tendon Stretching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of ThermaWedge™ Device and Achilles Tendon Stretching for the Treatment of Plantar Fasciopathy
Study Start Date : August 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Active Comparator: Achilles Tendon Stretching
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
ThermaWedge TM is a foam wedge device that is designed to be used in the treatment of plantar fasciopathy.

Other: Achilles Tendon Stretching
Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.

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

Other: Achilles Tendon Stretching
Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518841


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z4
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jack Taunton, MD University of British Columbia
Publications:
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Responsible Party: Jack Taunton, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02518841    
Other Study ID Numbers: H14-01870
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by Jack Taunton, University of British Columbia:
ThermaWedge TM
stretches
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases