Study Results
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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COMPLETED
PHASE3
28 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Sham pulsed radio-frequency electromagnetic 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
ActiPatch PRFE Device
Actipatch PRFE device
Interventions
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Sham pulsed radio-frequency electromagnetic device
Disabled PRFE device
ActiPatch PRFE Device
Actipatch PRFE device
Eligibility Criteria
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Inclusion Criteria
* 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 with heel pain present less than 3 months
18 Years
65 Years
ALL
No
Sponsors
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BioElectronics Corporation
INDUSTRY
University of British Columbia
OTHER
Responsible Party
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Locations
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Division of Sports Medicine
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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H11-01828
Identifier Type: -
Identifier Source: org_study_id
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