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

NeuroTherapia, Inc.

Status: Completed

Conditions: Arthritis; Pain; Osteoarthritis, Knee

Treatments: Device: EMPI Select TENS; Device: Placebo EMPI Select TENS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01641471

CCF 12-476

Details and patient eligibility

About

Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)

Full description

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

Active TENS

Experimental group

Description:

Active TENS (EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.

Treatment:

Device: EMPI Select TENS

Placebo TENS

Placebo Comparator group

Description:

Placebo TENS (Placebo EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.

Treatment:

Device: Placebo EMPI Select TENS