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NCT Number: NCT01641471

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

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMPI Select TENS

Device

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

Placebo EMPI Select TENS

Device

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

Primary outcomes

  1. Narcotic Usage

    Time frame: Through 6 weeks after surgery

    Morphine Equivalent dose, mg/kg

Secondary outcomes

  1. Visual Analog Pain Score (VAS)

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

    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.

  2. Functional Assessments

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

    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.

  3. General Health Outcome - SF-12 Physical Component Summary

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

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • DJO Incorporated

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2012
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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