Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)
Osteoarthritis, Knee, Arthritis, Pain
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total Knee Arthroplasty (TKA), Transcutaneous Electrical Nerve Stimulation (TENS), Pain, Function, Knee Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active TENS
Placebo TENS
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.
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.