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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rakel, Barbara A, University of Iowa
ClinicalTrials.gov Identifier:
NCT01364870
First received: May 31, 2011
Last updated: February 9, 2012
Last verified: May 2011
  Purpose

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 Intervention
Unilateral Primary Osteoarthritis of Knee
Primary Osteoarthritis of Knee Nos
Device: Placebo TENS
Device: Intense TENS (EMPI Select TENS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of TENS on Hyperalgesia, Pain With Movement, and Function After TKR

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Self-Reported Pain with Movement [ Time Frame: 1 day post-op, 2 days post-op, and 6-wks post-op ] [ Designated as safety issue: No ]
    While subject's knee flexion and extension is measured, they report their pain on 0-20 NRS.


Secondary Outcome Measures:
  • Pressure pain threshold [ Time Frame: 2 days post-op and 6-wks post-op ] [ Designated as safety issue: No ]
    A handheld dignital pressure algometer (Somedic AB, Farsta, Sweden), is used to assess PPT with the 1cm2 circular probe. Pressure is applied at 40 kPa/s and patients are instructed to press the hand held response switch when the sensation first becomes painful.

  • Thermal Threshold, Tolerance, Pain Intensity, and Summation [ Time Frame: 2 days post-op, 6 wks post-op ] [ Designated as safety issue: No ]
    TSA II NeuroSensory Analyzer used. For threshold and tolerance, the 5 cm2 probe placed with initial temp at 37 degrees C and increased at 1 degree/sec to max of 52 degrees C. Subject indicates when first becomes painful and when reaches worst pain imaginable, respectively. For summation, a temperature is identified that subject rates at 12 on 0-20 NRS; that temp is used for 20 seconds, with subj reporting pain at 0 sec, 10 sec, and 20 sec. Pain reported at 0 sec is used as pain intensity measure.

  • Cutaneous Mechanical Pain testing [ Time Frame: 6-wks post-op ] [ Designated as safety issue: No ]
    Assessed with a Von Frey filament (5.88), applied to skin; subjects rate pain on a 0-20 NRS>

  • Gait Distance Test (from Iowa Gait test) [ Time Frame: 2 days post-op and 6 wks post-op ] [ Designated as safety issue: No ]
    Subjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain and distance walked are assessed.

  • Accelerometer [ Time Frame: 6-wks post-op ] [ Designated as safety issue: Yes ]
    The ActivPAL activity monitor is worn by subject for one week after the 6-wk visit. Average cadence, avg METS per day, time sitting/lying, time standing, avg steps per day, and time spent in transition per day are measured.


Estimated Enrollment: 340
Study Start Date: May 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intense 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: Intense TENS (EMPI Select 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.

Detailed Description:

The investigators propose 3 specific aims:

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364870

Contacts
Contact: Barbara Rakel, PhD, RN 319 335 7036 barbara-rakel@uiowa.edu
Contact: Nyla Logsden-Sackett, MS 319 335 6589 nyla-logsden-sackett@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Barbara Rakel, PhD, RN    319-335-7036    barbara-rakel@uiowa.edu   
Contact: Nyla Logsden-Sackett, MS    319 335 6589    nyla-logsden-sackett@uiowa.edu   
Sub-Investigator: Kathleen Sluka, PhD,         
Sub-Investigator: Keela Herr, PhD, RN         
Sub-Investigator: Charles Clark, MD         
Sub-Investigator: Rita Frantz, PhD, RN         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Barbara Rakel, PhD, RN University of Iowa
Study Director: Nyla Logsden-Sackett, MS University of Iowa
  More Information

No publications provided

Responsible Party: Rakel, Barbara A, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01364870     History of Changes
Other Study ID Numbers: R01NR009844
Study First Received: May 31, 2011
Last Updated: February 9, 2012
Health Authority: United States: Instituional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014