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

Barbara A Rakel

Status: Completed

Conditions: Unilateral Primary Osteoarthritis of Knee; Primary Osteoarthritis of Knee Nos

Treatments: Device: Active TENS; Device: Placebo TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT01364870

200706725

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 30 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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317 participants in 3 patient groups, including a placebo group

Active TENS

Active Comparator group

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).

Treatment:

Device: Active TENS

Placebo TENS

Placebo Comparator group

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.

Treatment:

Device: Placebo TENS

Standard Care

No Intervention group

Description:

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