Back to resultsEffect of TENS for Pain and Function After Total Knee Replacement (TANK)
Primary Purpose
Unilateral Primary Osteoarthritis of Knee, Primary Osteoarthritis of Knee Nos
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo TENS
Active TENS
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Primary Osteoarthritis of Knee focused on measuring Knee OA, TENS, Total knee replacement, Knee arthroplasty, total unilateral knee replacement
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).
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Active TENS
Placebo TENS
Standard Care
Arm Description
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).
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.
Subjects randomized to "Standard Care" will be given no TENS unit.
Outcomes
Primary Outcome Measures
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").
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").
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01364870
Brief Title
Effect of TENS for Pain and Function After Total Knee Replacement
Acronym
TANK
Official Title
Effect of TENS on Hyperalgesia, Pain With Movement, and Function After TKR
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barbara A Rakel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Primary Osteoarthritis of Knee, Primary Osteoarthritis of Knee Nos
Keywords
Knee OA, TENS, Total knee replacement, Knee arthroplasty, total unilateral knee replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active TENS
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo TENS
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Subjects randomized to "Standard Care" will be given no TENS unit.
Intervention Type
Device
Intervention Name(s)
Placebo TENS
Intervention Description
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
Intervention Name(s)
Active TENS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Self-Reported Pain With Movement
Description
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").
Time Frame
1 day post-op
Title
Self-reported Pain With Walking (From Iowa Gait Test)
Description
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").
Time Frame
2 days post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Rakel, PhD, RN
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29777950
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of TENS for Pain and Function After Total Knee Replacement
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