Evaluation of Electrical Nerve Stimulation (TENS) Therapy 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.

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.