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

NCT ID: NCT01641471

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-06-30

Brief Summary

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

Detailed 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.

Conditions

Osteoarthritis, Knee; Arthritis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active 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.

Group Type: EXPERIMENTAL

EMPI Select TENS

Intervention Type: DEVICE

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

Placebo TENS

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.

Group Type: PLACEBO_COMPARATOR

Placebo EMPI Select TENS

Intervention Type: DEVICE

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

Interventions

EMPI Select TENS

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DJO Incorporated

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Wael Barsoum

MD, Chairman of Surgical Operations

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wael K Barsoum, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 6332127 (View on PubMed)

Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. doi: 10.3928/0147-7447-19861001-06.

Reference Type: BACKGROUND

PMID: 3490659 (View on PubMed)

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. doi: 10.1016/S1090-3801(02)00098-8.

Reference Type: BACKGROUND

PMID: 12600800 (View on PubMed)

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. doi: 10.1016/s0883-5403(03)00458-3.

Reference Type: BACKGROUND

PMID: 14716650 (View on PubMed)

Other Identifiers

CCF 12-476

Identifier Type: -

Identifier Source: org_study_id