Plantar Fasciitis, Plantar Fasciopathy
Conditions
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.
Interventions
DEVICESham pulsed radio-frequency electromagnetic device
Disabled PRFE device
DEVICEActiPatch PRFE Device
Actipatch PRFE device
Sponsors
BioElectronics Corporation
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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* Patients who have refused, are unable to give or have withdrawn consent * Patients with heel pain present less than 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) for pain | 4 Weeks Follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Visual analog scale for pain | 26 weeks |
| Foot and ankle disability index | 26 weeks |
| Tegner activity scale | 26 weeks |
Countries
Canada
Outcome results
None listed