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ActiPatch Plantar Fasciitis Clinical Trial

This study has been completed.
BioElectronics Corporation
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: September 7, 2011
Last updated: February 27, 2014
Last verified: September 2011

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 Intervention Phase
Plantar Fasciitis
Plantar Fasciopathy
Device: Sham pulsed radio-frequency electromagnetic device
Device: ActiPatch PRFE Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) for pain [ Time Frame: 4 Weeks Follow-up ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Actipatch
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01431066

Canada, British Columbia
Division of Sports Medicine
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
BioElectronics Corporation
  More Information

Responsible Party: University of British Columbia Identifier: NCT01431066     History of Changes
Other Study ID Numbers: H11-01828
Study First Received: September 7, 2011
Last Updated: February 27, 2014

Additional relevant MeSH terms:
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases processed this record on April 28, 2017