Skip Navigation

Advertise|Press|Contact|FAQ|About Us


Home » Clinical Trials » Pain

Clinical Trial Details


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)


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



Both Male and Female


18 to 85 Years

Overall Status


Lead Sponsor

The Cleveland Clinic


19 Months

Facility Type



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

Wael K Barsoum, MD
Principal Investigator

Viktor E Krebs, MD

Robert Molloy, MD

Trevor G Murray, MD

Carlos A Higuera, MD

NCT ID: NCT01641471

Date Last Changed: March 25, 2014

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.