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Effect of TENS for Pain and Function After Total Knee Replacement (TANK)

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ClinicalTrials.gov Identifier: NCT01364870
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Barbara A Rakel, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Unilateral Primary Osteoarthritis of Knee Primary Osteoarthritis of Knee Nos Device: Placebo TENS Device: Active TENS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of TENS on Hyperalgesia, Pain With Movement, and Function After TKR
Study Start Date : May 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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).
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).
Placebo Comparator: 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.
Device: 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.
No Intervention: Standard Care
Subjects randomized to "Standard Care" will be given no TENS unit.



Primary Outcome Measures :
  1. Self-Reported Pain With Movement [ Time Frame: 1 day post-op ]
    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").

  2. Self-reported Pain With Walking (From Iowa Gait Test) [ Time Frame: 2 days post-op ]
    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").



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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364870


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Barbara A Rakel
Investigators
Principal Investigator: Barbara Rakel, PhD, RN University of Iowa

Responsible Party: Barbara A Rakel, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01364870     History of Changes
Other Study ID Numbers: 200706725
First Posted: June 3, 2011    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Barbara A Rakel, University of Iowa:
Knee OA
TENS
Total knee replacement
Knee arthroplasty
total unilateral knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases