Clinical trial NCT01641471: Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)
Official title: Prospective Evaluation of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief Following Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Arthritis
Pain
Keywords: Total Knee Arthroplasty (TKA)
Transcutaneous Electrical Nerve Stimulation (TENS)
Pain
Function
Knee Osteoarthritis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: DJO Incorporated
First posted: 2012-07-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Narcotic Usage
timeFrame: Through 6 weeks after surgery
Secondary outcomes:
measure: Visual Analog Pain Score (VAS)
timeFrame: 6 weeks (+/- 3 days) postoperative
measure: Functional Assessments
timeFrame: 6 weeks (+/- 3 days) postoperative
measure: General Health Outcome - SF-12 Physical Component Summary
timeFrame: 6 weeks (+/- 3 days) postoperative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Wael K Barsoum, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1016/S1090-3801(02)00098-8.
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. doi: 10.1016/s0883-5403(03)00458-3.