Effect of TENS for Pain and Function After Total Knee Replacement

NCT ID: NCT01364870

Last Updated: 2017-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-05-31

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

Study Design

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

Study Groups

Active TENS

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).

Group Type: ACTIVE_COMPARATOR

Active TENS

Intervention Type: 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).

Placebo TENS

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.

Group Type: PLACEBO_COMPARATOR

Placebo TENS

Intervention Type: 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.

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Placebo TENS

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.

Intervention Type: DEVICE

Active TENS

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barbara A Rakel

OTHER

Sponsor Role: lead

Responsible Party

Barbara A Rakel

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Barbara Rakel, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29777950 (View on PubMed)

Other Identifiers

200706725

Identifier Type: -

Identifier Source: org_study_id