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

Primary Purpose

Plantar Fasciitis, Plantar Fasciopathy

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

ThermaWedge TM

Achilles Tendon Stretching

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring ThermaWedge TM, stretches

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Achilles Tendon Stretching

ThermaWedge TM

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02518841

First Posted

July 13, 2015

Last Updated

October 29, 2018

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02518841

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Fasciitis, Plantar Fasciopathy

Keywords

ThermaWedge TM, stretches

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Achilles Tendon Stretching

Arm Type

Active Comparator

Arm Description

Arm Title

ThermaWedge TM

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ThermaWedge TM

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Achilles Tendon Stretching

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

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

Title

Foot and Ankle Disability Index - assessing change in disability

Description

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.

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

Title

Numerical Rating Scale - assessing change in severity of pain

Description

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.

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack Taunton, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T1Z4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

16882901

Citation

Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.

Results Reference

background

PubMed Identifier

24172656

Citation

Ryan M, Hartwell J, Fraser S, Newsham-West R, Taunton J. Comparison of a physiotherapy program versus dexamethasone injections for plantar fasciopathy in prolonged standing workers: a randomized clinical trial. Clin J Sport Med. 2014 May;24(3):211-7. doi: 10.1097/JSM.0000000000000021.

Results Reference

background

PubMed Identifier

15134610

Citation

Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. doi: 10.1177/107110070402500505.

Results Reference

background

PubMed Identifier

20048543

Citation

Ryan M, Fraser S, McDonald K, Taunton J. Examining the degree of pain reduction using a multielement exercise model with a conventional training shoe versus an ultraflexible training shoe for treating plantar fasciitis. Phys Sportsmed. 2009 Dec;37(4):68-74. doi: 10.3810/psm.2009.12.1744.

Results Reference

background

Citation

W. Guy. ECDEU assessment manual for psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare; 1976.

Results Reference

background

PubMed Identifier

21916393

Citation

Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.

Results Reference

background

PubMed Identifier

20046623

Citation

Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

Results Reference

background

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

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