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

University of British Columbia

Status: Completed

Conditions: Plantar Fasciitis; Plantar Fasciopathy

Treatments: Other: Achilles Tendon Stretching; Device: ThermaWedge TM

Study type: Interventional

Funder types: Other

Identifiers

NCT02518841

H14-01870

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Achilles Tendon Stretching

Active Comparator group

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.

Treatment:

Other: Achilles Tendon Stretching

Device: ThermaWedge TM

ThermaWedge TM

Experimental group

Description:

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

Treatment:

Other: Achilles Tendon Stretching

Device: ThermaWedge TM