N/A
N=116
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)
Osteoarthritis, Knee · Arthritis · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01641471 ↗Enrolled (actual)
116
Serious AEs
4.6%
Results posted
Mar 2016
Primary outcome: Primary: Narcotic Usage — 997.7; 1025.8 morphine equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EMPI Select TENS (Device); Placebo EMPI Select TENS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Usage |
997.7; 1025.8 | — |
| SECONDARY Visual Analog Pain Score (VAS) |
1.57; 1.54 | — |
| SECONDARY Functional Assessments |
9.31; 10.39 | — |
| SECONDARY General Health Outcome - SF-12 Physical Component Summary |
33.57; 31.78 | — |
Summary
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)
Eligibility Criteria
Inclusion Criteria
- Patients undergoing unilateral primary total knee arthroplasty
- Patients who are between the ages of 18-85 years
- Patient has signed informed consent
Exclusion Criteria
- Patients who live >100 miles from the Cleveland Clinic main campus (9500 Euclid Ave., Cleveland, OH 44195)
- Patients who will not receive a femoral nerve catheter for surgery
- Patients who are not planned to be discharged directly home following surgery
- Patients who have used a TENS device in the past
- Preoperative daily use of narcotics (i.e., high tolerance)
- Already enrolled in another research study, including the present study for contralateral knee
- Patients with a history of epilepsy
- Patients with a cardiac pacemaker
- Patients who are a risk for poor compliance or have a poor understanding of the use of the TENS device
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Data sourced from ClinicalTrials.gov (NCT01641471). 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.