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

NCT02211534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-10-27

Study results available
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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)

Conditions

  • Post-Operative Pain Following Total Knee Arthroplasty

Interventions

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.

Sponsors & Collaborators

  • Regenesis Biomedical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02211534 on ClinicalTrials.gov