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Clinical Trials/NCT01431066
NCT01431066CompletedPhase 3

Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy

University of British Columbia2 sites in 1 country28 target enrollmentStarted: December 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
28
Locations
2
Primary Endpoint
Visual Analog Scale (VAS) for pain
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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  • •Patients who have refused, are unable to give or have withdrawn consent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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) for pain

Time Frame: 4 Weeks Follow-up

Secondary Outcomes

  • Visual analog scale for pain(26 weeks)
  • Foot and ankle disability index(26 weeks)
  • Tegner activity scale(26 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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