Prospective Evaluation of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief Following Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Narcotic Usage
研究概览
简要总结
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)
详细描述
A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA procedures; 58 patients will be randomly selected to be treated postoperatively with an active TENS unit and the other 58 patients will be randomly selected to be treated with the placebo TENS unit (control group). Patients will be enrolled at two sites within the Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and control groups will receive a femoral nerve catheter, standard during a primary TKA. It is hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic usage, reduce pain, and allow for a quicker return to function following TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary total knee arthroplasty
- •Patients who are between the ages of 18-85 years
- •Patient has signed informed consent
排除标准
- •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.
研究组 & 干预措施
Active TENS
Active TENS (EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
干预措施: EMPI Select TENS (Device)
Placebo TENS
Placebo TENS (Placebo EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
干预措施: Placebo EMPI Select TENS (Device)
结局指标
主要结局
Narcotic Usage
时间窗: Through 6 weeks after surgery
Morphine Equivalent dose, mg/kg
次要结局
- Visual Analog Pain Score (VAS)(6 weeks (+/- 3 days) postoperative)
- Functional Assessments(6 weeks (+/- 3 days) postoperative)
- General Health Outcome - SF-12 Physical Component Summary(6 weeks (+/- 3 days) postoperative)
研究者
Wael Barsoum
MD, Chairman of Surgical Operations
The Cleveland Clinic