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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641471
• Other study ID #: CCF 12-476
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: March 2, 2018
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: March 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Device:
• EMPI Select TENS
The unit is capable of 0-60 milliamps of output current.
• Placebo EMPI Select TENS
The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	DJO Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (4)

Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. — View Citation

Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. — View Citation

Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. — View Citation

Cornell PE, Lopez AL, Malofsky H. Pain reduction with transcutaneous electrical nerve stimulation after foot surgery. J Foot Surg. 1984 Jul-Aug;23(4):326-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic Usage	Morphine Equivalent dose, mg/kg	Through 6 weeks after surgery
Secondary	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.	6 weeks (+/- 3 days) postoperative
Secondary	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.	6 weeks (+/- 3 days) postoperative
Secondary	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.	6 weeks (+/- 3 days) postoperative