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ActiPatch Plantar Fasciitis Clinical Trial

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ClinicalTrials.gov Identifier: NCT01431066
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : March 3, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Plantar Fasciitis Plantar Fasciopathy Device: Sham pulsed radio-frequency electromagnetic device Device: ActiPatch PRFE Device Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : December 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Visual analog scale for pain [ Time Frame: 26 weeks ]
  2. Foot and ankle disability index [ Time Frame: 26 weeks ]
  3. Tegner activity scale [ Time Frame: 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431066


Locations
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
ClinicalTrials.gov Identifier: NCT01431066     History of Changes
Other Study ID Numbers: H11-01828
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: September 2011

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