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