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

NCT01641471 | Completed Results

• 1 other identifier: CCF 12-476
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee; Arthritis; Pain

Keywords

Total Knee Arthroplasty (TKA); Transcutaneous Electrical Nerve Stimulation (TENS); Pain; Function; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Narcotic Usage

  Morphine Equivalent dose, mg/kg

  Through 6 weeks after surgery

Secondary Outcomes (3)

• Visual Analog Pain Score (VAS)

  6 weeks (+/- 3 days) postoperative

• Functional Assessments

  6 weeks (+/- 3 days) postoperative

• General Health Outcome - SF-12 Physical Component Summary

  6 weeks (+/- 3 days) postoperative

Study Arms (2)

Active TENS

EXPERIMENTAL

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.

Device: EMPI Select TENS

Placebo TENS

PLACEBO COMPARATOR

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.

Device: Placebo EMPI Select TENS

Interventions

EMPI Select TENS DEVICE

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

Active TENS

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.

Placebo TENS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral primary total knee arthroplasty
• Patients who are between the ages of 18-85 years
• Patient has signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• DJO Incorporated: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• 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.

  PMID: 6332127 BACKGROUND

• 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.

  PMID: 3490659 BACKGROUND

• 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.

  PMID: 12600800 BACKGROUND

• 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.

  PMID: 14716650 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Program Manager
• Organization: Cleveland Clinic - Section of Adult Reconstrution

klikaa@ccf.org

216-444-4954

Study Officials

• Wael K Barsoum, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chairman of Surgical Operations

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: July 16, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 7, 2018
• Results First Posted: March 10, 2016

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)