ActiPatch Plantar Fasciitis Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
Bioelectronics Corp.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01431066
First received: September 7, 2011
Last updated: February 27, 2014
Last verified: September 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analog scale for pain [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Foot and ankle disability index [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Tegner activity scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431066

Locations
Canada, British Columbia
Division of Sports Medicine
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Bioelectronics Corp.
  More Information

No publications provided

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

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on July 09, 2014