ActiPatch Plantar Fasciitis Clinical Trial

Phase 3

Completed

• Conditions: Plantar Fasciitis; Plantar Fasciopathy
• Interventions: Device: Sham pulsed radio-frequency electromagnetic device; Device: ActiPatch PRFE Device

• Registration Number: NCT01431066
• Lead Sponsor: University of British Columbia

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2011-09
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-09
• Study Start: 2011-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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• Patients who have refused, are unable to give or have withdrawn consent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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sham pulsed radio-frequency electromagnetic device	Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.
Actipatch	ActiPatch PRFE Device	Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for pain	4 Weeks Follow-up

Secondary Outcome Measures

Name	Time	Method
Visual analog scale for pain	26 weeks
Foot and ankle disability index	26 weeks
Tegner activity scale	26 weeks

Trial Locations

Locations (1)

Division of Sports Medicine; 🇨🇦 Vancouver, British Columbia, Canada