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Clinical Trial Details

NCT ID: NCT01641471
Date Last Changed: March 25, 2014

Overview

Research Study Summary

A Phase 4 clinical study for patients with Osteoarthritis, Knee, Arthritis or Pain

Research Study Title

Prospective Evaluation of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief Following Total Knee Arthroplasty (TKA)

Purpose

A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA procedures; 58 patients will be randomly selected to be treated postoperatively with an active TENS unit and the other 58 patients will be randomly selected to be treated with the placebo TENS unit (control group). Patients will be enrolled at two sites within the Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and control groups will receive a femoral nerve catheter, standard during a primary TKA. It is hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic usage, reduce pain, and allow for a quicker return to function following TKA.

To Learn more

Recruitment Details

Phase
4
Gender
Both Male and Female
Age
18 to 85 Years
Overall Status
Recruiting
Lead Sponsor
The Cleveland Clinic
Duration
19 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years to 85 Years

Inclusion Criteria:

  • Patients undergoing unilateral primary total knee arthroplasty

  • Patients who are between the ages of 18-85 years

  • Patient has signed informed consent

Exclusion Criteria:

  • Patients who live > 100 miles from the Cleveland Clinic main campus (9500 Euclid Ave., Cleveland, OH 44195)

  • Patients who will not receive a femoral nerve catheter for surgery

  • Patients who are not planned to be discharged directly home following surgery

  • Patients who have used a TENS device in the past

  • Preoperative daily use of narcotics (i.e., high tolerance)

  • Already enrolled in another research study, including the present study for contralateral knee

  • Patients with a history of epilepsy

  • Patients with a cardiac pacemaker

  • Patients who are a risk for poor compliance or have a poor understanding of the use of the TENS device

  • Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

Site Locations (1)

Country State City Zip Facility and Contact
United States Ohio Cleveland 44195 Cleveland Clinic
Alison K Klika, MS
216-444-4954
klikaa@ccf.org

Wael K Barsoum, MD
Principal Investigator

Viktor E Krebs, MD
Sub-Investigator

Robert Molloy, MD
Sub-Investigator

Trevor G Murray, MD
Sub-Investigator

Carlos A Higuera, MD
Sub-Investigator

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