ActiPatch Plantar Fasciitis Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01431066|
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : March 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis Plantar Fasciopathy||Device: Sham pulsed radio-frequency electromagnetic device Device: ActiPatch PRFE Device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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
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
- Visual Analog Scale (VAS) for pain [ Time Frame: 4 Weeks Follow-up ]
- Visual analog scale for pain [ Time Frame: 26 weeks ]
- Foot and ankle disability index [ Time Frame: 26 weeks ]
- Tegner activity scale [ Time Frame: 26 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431066
|Canada, British Columbia|
|Division of Sports Medicine|
|Vancouver, British Columbia, Canada, V6T 1Z3|