ActiPatch Plantar Fasciitis Clinical Trial

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431066
• Other study ID #: H11-01828
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2011
• Last updated: February 27, 2014
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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• Patients who have refused, are unable to give or have withdrawn consent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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis
• Plantar Fasciopathy

Intervention

Device:
• Sham pulsed radio-frequency electromagnetic device
Disabled PRFE device
• ActiPatch PRFE Device
Actipatch PRFE device

Locations

Country	Name	City	State
Canada	Division of Sports Medicine	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	BioElectronics Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) for pain		4 Weeks Follow-up	No
Secondary	Visual analog scale for pain		26 weeks	No
Secondary	Foot and ankle disability index		26 weeks	No
Secondary	Tegner activity scale		26 weeks	No