ActiPatch Plantar Fasciitis Clinical Trial

University of British Columbia

Status and phase: Completed; Phase 3

Conditions: Plantar Fasciitis; Plantar Fasciopathy

Treatments: Device: ActiPatch PRFE Device; Device: Sham pulsed radio-frequency electromagnetic device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01431066

H11-01828

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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• Patients who have refused, are unable to give or have withdrawn consent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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.

Treatment:

Device: Sham pulsed radio-frequency electromagnetic device

Actipatch

Experimental group

Description:

Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy

Treatment:

Device: ActiPatch PRFE Device