NCT02211534

Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty

A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in the Treatment of Persistent Post-Operative Pain Following Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Regenesis Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether pulsed electromagnetic energy field (PEMF) therapy is effective in the treatment of persistent pain following total knee arthroplasty (TKA)

Detailed description

This is a multi-site randomized, double-blinded, parallel-group prospective pilot study of the analgesic effectiveness of twice-daily PEMF therapy in the treatment of persistent post-operative pain following Total Knee Arthroplasty (TKA). Following a run-in period of 10 days to collect their baseline pain intensity scores, activity levels and opioid consumption, eligible subjects will be randomized in a 2:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device. Subjects will self-treat twice daily for 60 days while at home. Subjects will collect electronic patient-reported outcome (ePRO) data each morning through Day 75. Subjects will be evaluated at the research center for Interim Visits at Day 21, Day 41, Day 61 and Day 75 for assessment of safety, concomitant medications, range of motion, weight, peripheral edema, and quality of life outcomes. At Day 90, Day 150, and Day 240 assessment of pain intensity, opioid consumption, safety, review of concomitant medications and interval history will be performed, with data collected via telephone contact.

Conditions

• Post-Operative Pain Following Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Pulsed Electromagnetic Field Device (Provant)	The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment.
DEVICE	Sham Pulsed Electromagnetic Field Device	The Sham device will be identical in appearance, physical characteristics and operation to the Active device.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-08-07
• Last updated: 2017-10-27
• Results posted: 2017-10-27

Locations

14 sites across 1 country: United States