N/A
Completed N=317
Effect of TENS for Pain and Function After Total Knee Replacement
Unilateral Primary Osteoarthritis of Knee · Primary Osteoarthritis of Knee Nos
Source: ClinicalTrials.gov NCT01364870 ↗
Enrolled (actual)
317
Serious AEs
5.1%
Results posted
Nov 2017
Primary outcomePrimary: Self-Reported Pain With Movement — 9.5; 10; 14 scores on a scale — p=0.016
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported Pain With Movement |
9.5; 10; 14 | 0.016 sig |
| PRIMARY Self-reported Pain With Walking (From Iowa Gait Test) |
8; 10; 10 | 0.008 sig |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01364870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.