ActiPatch Plantar Fasciitis Clinical Trial

NCT ID: NCT01431066

Last Updated: 2014-03-03

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

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Sham pulsed radio-frequency electromagnetic device

Intervention Type DEVICE

Disabled PRFE device

Actipatch

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

Group Type EXPERIMENTAL

ActiPatch PRFE Device

Intervention Type DEVICE

Actipatch PRFE device

Interventions

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Sham pulsed radio-frequency electromagnetic device

Disabled PRFE device

Intervention Type DEVICE

ActiPatch PRFE Device

Actipatch PRFE device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioElectronics Corporation

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Sports Medicine

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H11-01828

Identifier Type: -

Identifier Source: org_study_id

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