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

NCT ID: NCT02518841

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Plantar Fasciitis Plantar Fasciopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

ThermaWedge TM

Intervention Type DEVICE

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

Achilles Tendon Stretching

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

ThermaWedge TM

Intervention Type DEVICE

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

Achilles Tendon Stretching

Intervention Type OTHER

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

Interventions

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ThermaWedge TM

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

Intervention Type DEVICE

Achilles Tendon Stretching

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jack Taunton

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jack Taunton, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 16882901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24172656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15134610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20048543 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 21916393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20046623 (View on PubMed)

Other Identifiers

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H14-01870

Identifier Type: -

Identifier Source: org_study_id

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