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

The Cleveland Clinic116 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Osteoarthritis, Knee Arthritis Pain

Interventions

EMPI Select TENSDEVICE

The unit is capable of 0-60 milliamps of output current.

Placebo EMPI Select TENSDEVICE

The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Narcotic Usage

Morphine Equivalent dose, mg/kg

Time frame: Through 6 weeks after surgery

Secondary Outcomes

Visual Analog Pain Score (VAS)

Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.

Time frame: 6 weeks (+/- 3 days) postoperative

Functional Assessments

Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.

Time frame: 6 weeks (+/- 3 days) postoperative

General Health Outcome - SF-12 Physical Component Summary

Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported.

Time frame: 6 weeks (+/- 3 days) postoperative

Data from ClinicalTrials.gov

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