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

• 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

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