NCT01694199

Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Regenesis Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.

Detailed description

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.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DEVICE	Pulsed Radiofrequency Energy (PRFE)	The intervention is pulsed radiofrequencyenergy (PRFE).
DEVICE	No Pulsed Radiofrequency Energy (PRFE)	Sham (placebo) with no therapeutic device activity

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-09-27
• Last updated: 2017-05-02
• Results posted: 2017-05-02

Locations

3 sites across 1 country: United States