NCT01364870

Effect of TENS for Pain and Function After Total Knee Replacement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Barbara A Rakel · Academic / Other
• Sex: All
• Age: 30 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unilateral Primary Osteoarthritis of Knee
• Primary Osteoarthritis of Knee Nos

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2011-06-03
• Last updated: 2017-11-30
• Results posted: 2017-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study