Effect of TENS for Pain and Function After Total Knee Replacement

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.

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Key information

Conditions

Unilateral Primary Osteoarthritis of Knee Primary Osteoarthritis of Knee Nos

Age range

30 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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).

Primary outcomes

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").
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").

Sponsors and collaborators

Lead sponsor

Barbara A Rakel

Other

Registry information

Official study title

Effect of TENS on Hyperalgesia, Pain With Movement, and Function After TKR

Acronym: TANK

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Jun 3, 2011
Registry last updated: Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed