ActiPatch Plantar Fasciitis Clinical Trial

February 27, 2014 updated by: University of British Columbia

Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy

Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.

The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.

The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Division of Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with diagnosis of plantar fasciitis agreeing to participate
  • Over 18 years old
  • Able to wear unit and keep data up-to-date records of use
  • Agree to forgo additional treatments during the study period

Exclusion Criteria:

  • Patients who have refused, are unable to give or have withdrawn consent
  • Patients with heel pain present less than 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.
Device: Sham pulsed radio-frequency electromagnetic device
Disabled PRFE device
EXPERIMENTAL: Actipatch
Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy
Device: ActiPatch PRFE Device
Actipatch PRFE device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale (VAS) for pain
Time Frame: 4 Weeks Follow-up
4 Weeks Follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual analog scale for pain
Time Frame: 26 weeks
26 weeks
Foot and ankle disability index
Time Frame: 26 weeks
26 weeks
Tegner activity scale
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

BioElectronics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (ESTIMATE)

September 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-01828

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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