A Phase 3 interventional study of Sham pulsed radio-frequency electromagnetic device and ActiPatch PRFE Device in Plantar Fasciitis and Plantar Fasciopathy, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-03.
Sponsored by University of British Columbia · Phase 3, Interventional, and Treatment
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.
235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.
This study's enrollment of 28 is below the median of 54 across 192 interventional studies indexed under Fasciitis.
Browse Fasciitis studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy
Device: ActiPatch PRFE Device
Disabled 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
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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University of British Columbia