ActiPatch Plantar Fasciitis Clinical Trial
Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 9, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMarch 3, 2014
September 1, 2011
1.6 years
September 7, 2011
February 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS) for pain
4 Weeks Follow-up
Secondary Outcomes (3)
Visual analog scale for pain
26 weeks
Foot and ankle disability index
26 weeks
Tegner activity scale
26 weeks
Study Arms (2)
Control
PLACEBO COMPARATORSham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.
Actipatch
EXPERIMENTALUse of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who have refused, are unable to give or have withdrawn consent
- Patients with heel pain present less than 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- BioElectronics Corporationcollaborator
Study Sites (1)
Division of Sports Medicine
Vancouver, British Columbia, V6T 1Z3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 9, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 3, 2014
Record last verified: 2011-09