CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Pulsed Electromagnetic Field Device (Provant) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02211534
NCT02211534N/ACompleted

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

Regenesis Biomedical, Inc.·interventional·Posted Aug 7, 2014·Updated Oct 27, 2017

In Brief

A clinical study evaluating Pulsed Electromagnetic Field Device (Provant) and Sham Pulsed Electromagnetic Field Device for Post-Operative Pain Following Total Knee Arthroplasty. Completed, enrolled 35 participants across 14 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 7, 2014
Enrollment StartSep 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.9 years ago

Interventions

Pulsed Electromagnetic Field Device (Provant)device

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.

Sham Pulsed Electromagnetic Field Devicedevice

The Sham device will be identical in appearance, physical characteristics and operation to the Active device.