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A Multicenter, Randomized, Sham-Controlled, Double-Blinded Study to Evaluate the Analgesic Efficacy and Safety of Pulsed Radiofrequency Energy (PRFE) in Bunionectomy Surgery for the Treatment of Post-Operative Pain

Post-surgical Pain Clinical Trial

Clinical Trial Summary

The clinical study's primary objective is to compare the overall analgesic effect of the Provant Therapy System (test device) to an identical sham device (placebo) in subjects experiencing post-operative pain following first metatarsal bunion surgery. The study hypothesis is that, over the first 72 hours (3 days) after the initial test device treatment, subjects treated with an active test device will show a statistically significant difference (reduction) in pain intensity scores when compared with subjects treated with a sham (placebo) device. Treatment with the test device will continue through the 168 hour (7 day) timepoint. Safety will be followed through 28 days.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01694199
Study type Interventional
Source Regenesis Biomedical, Inc.
Contact
Status Terminated
Phase N/A
Start date September 2012
Completion date December 2012
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