Pain Clinical Trial
Official title:
Prospective Evaluation of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief Following Total Knee Arthroplasty (TKA)
Verified date | March 2018 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)
Status | Completed |
Enrollment | 116 |
Est. completion date | June 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | DJO Incorporated |
United States,
Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. — View Citation
Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. — View Citation
Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. — View Citation
Cornell PE, Lopez AL, Malofsky H. Pain reduction with transcutaneous electrical nerve stimulation after foot surgery. J Foot Surg. 1984 Jul-Aug;23(4):326-33. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Narcotic Usage | Morphine Equivalent dose, mg/kg | Through 6 weeks after surgery | |
Secondary | Visual Analog Pain Score (VAS) | Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain. | 6 weeks (+/- 3 days) postoperative | |
Secondary | Functional Assessments | Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. | 6 weeks (+/- 3 days) postoperative | |
Secondary | General Health Outcome - SF-12 Physical Component Summary | Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported. | 6 weeks (+/- 3 days) postoperative |
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