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ActiPatch Plantar Fasciitis Clinical Trial

Primary Purpose

Plantar Fasciitis, Plantar Fasciopathy

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Sham pulsed radio-frequency electromagnetic device
ActiPatch PRFE Device
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Patients who have refused, are unable to give or have withdrawn consent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

Sites / Locations

  • Division of Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Actipatch

Arm Description

Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.

Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) for pain

Secondary Outcome Measures

Visual analog scale for pain
Foot and ankle disability index
Tegner activity scale

Full Information

First Posted
September 7, 2011
Last Updated
February 27, 2014
Sponsor
University of British Columbia
Collaborators
BioElectronics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01431066
Brief Title
ActiPatch Plantar Fasciitis Clinical Trial
Official Title
Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
BioElectronics Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.
Arm Title
Actipatch
Arm Type
Experimental
Arm Description
Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy
Intervention Type
Device
Intervention Name(s)
Sham pulsed radio-frequency electromagnetic device
Intervention Description
Disabled PRFE device
Intervention Type
Device
Intervention Name(s)
ActiPatch PRFE Device
Intervention Description
Actipatch PRFE device
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for pain
Time Frame
4 Weeks Follow-up
Secondary Outcome Measure Information:
Title
Visual analog scale for pain
Time Frame
26 weeks
Title
Foot and ankle disability index
Time Frame
26 weeks
Title
Tegner activity scale
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Sports Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

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ActiPatch Plantar Fasciitis Clinical Trial

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