Effect of TENS for Pain and Function After Total Knee Replacement

NCT01364870 | Completed Results DMC FDA Device

• 1 other identifier: 200706725
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia. Minimizing the severe pain experienced during required activities in the immediate postoperative period will promote functional recovery and prevent the development of new chronic pain syndromes.

Conditions

Unilateral Primary Osteoarthritis of Knee; Primary Osteoarthritis of Knee Nos

Keywords

Knee OA; TENS; Total knee replacement; Knee arthroplasty; total unilateral knee replacement

Outcome Measures

Primary Outcomes (2)

• Self-Reported Pain With Movement

  While subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").

  1 day post-op

• Self-reported Pain With Walking (From Iowa Gait Test)

  Subjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain was assessed with a Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").

  2 days post-op

Study Arms (3)

Active TENS

ACTIVE COMPARATOR

High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).

Device: Active TENS

Placebo TENS

PLACEBO COMPARATOR

Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.

Device: Placebo TENS

Standard Care

NO INTERVENTION

Subjects randomized to "Standard Care" will be given no TENS unit.

Interventions

Placebo TENS DEVICE

Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.

Placebo TENS

Active TENS DEVICE

High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).

Active TENS

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary osteoarthritis of the knee
• Speak English
• Unilateral total knee replacement

You may not qualify if:

• No ambulation, assisted or otherwise
• Use of TENS by subject in past 5 yrs
• Current use of TENS by someone else in subject's household
• Stroke or other condition which seriously impairs sensation in legs or ability to follow directions.
• Condition that precludes use of TENS (pacemaker, allergy to nickel, etc.)
• Chronic pain (other than in surgical knee) that is currently being treated or is severe. (Do not exclude for fibromyalgia).

Sponsors & Collaborators

• Barbara A Rakel: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Dindo L, Zimmerman MB, Hadlandsmyth K, StMarie B, Embree J, Marchman J, Tripp-Reimer T, Rakel B. Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. J Pain. 2018 Oct;19(10):1211-1221. doi: 10.1016/j.jpain.2018.04.016. Epub 2018 May 17.

  PMID: 29777950 DERIVED

Results Point of Contact

• Title: Barbara Rakel, PhD, RN, FAAN
• Organization: University of Iowa College of Nursing

barbara-rakel@uiowa.edu

319-335-7036

Study Officials

• Barbara Rakel, PhD, RN

  University of Iowa

  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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 30, 2017
• Results First Posted: November 30, 2017

Record last verified: 2017-10

Locations

US (1)