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OpenTrials
Completed

NCT Number: NCT01431066

ActiPatch Plantar Fasciitis Clinical Trial

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases Plantar Fasciopathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Sports Medicine

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Patients who have refused, are unable to give or have withdrawn consent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

Treatment and study plan

Sham pulsed radio-frequency electromagnetic device

Device

Disabled PRFE device

ActiPatch PRFE Device

Device

Actipatch PRFE device

Primary outcomes

  1. Visual Analog Scale (VAS) for pain

    Time frame: 4 Weeks Follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • BioElectronics Corporation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 9, 2011
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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