ActiPatch Plantar Fasciitis Clinical Trial
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.
|Plantar Fasciitis Plantar Fasciopathy||Device: Sham pulsed radio-frequency electromagnetic device Device: ActiPatch PRFE Device||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy|
- 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 ]
|Study Start Date:||December 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431066
|Canada, British Columbia|
|Division of Sports Medicine|
|Vancouver, British Columbia, Canada, V6T 1Z3|