Effect of TENS for Pain and Function After Total Knee Replacement

Not Applicable

Completed

• Conditions: Primary Osteoarthritis of Knee Nos; Unilateral Primary Osteoarthritis of Knee
• Interventions: Device: Active TENS; Device: Placebo TENS

• Registration Number: NCT01364870
• Lead Sponsor: Barbara A Rakel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Results First Submitted: 2017-03-31
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Results First Posted: 2017-11-30
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TENS	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).
Placebo TENS	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.

Primary Outcome Measures

Name	Time	Method
Self-Reported Pain With Movement	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)	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").

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States