NCT00717171终止4 期
Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair
VQ OrthoCare2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to provide informed consent to be included within this ACL study
- •Demonstrate a continued willingness to be compliant with the parameters established under the study;
- •Have no history of drug or alcohol abuse in the last 2 years;
- •Be either a male or female adult between the ages of 18 and 64;
- •Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a hamstring, patella tendon, Achilles tendon, or allograft procedure; and
- •Understand that there is no financial remuneration for participation in the study.
排除标准
- •Pregnant women
- •Insulin dependent diabetic patients
- •Patients with a demand type pacemaker
- •Patients who have a malignant tumor (other than basal cell epithelioma)
- •Patients with a known history of alcohol or drug abuse in the last 2 years
- •Patients who will not agree to provide informed consent to be included within this ACL study
- •Patients who demonstrate a continued unwillingness to be compliant with the parameters established under this study.
- •"Poor healers" as identified by the patient's medical history
- •Patients who have a history of sensitivity to surgical tape, electrode adhesives, etc.
- •Patients with a known history of RSD (reflex sympathetic dystrophy)
- •Patients with a history of chronic pain (on opiates or high dosage of NSAIDS for 3 months or greater)
- •Patients who have previously undergone an ACL reconstruction on the same knee
- •Patients with clinically varicose veins (clinically significant or symptomatic)
- •Patients whose history shows an abuse of diuretics or anti-inflammatory medications
- •Patients who will undergo multiple ligament surgery (i.e., ACL plus PCL, MCL, and/or LCL)
结局指标
主要结局
pain
时间窗: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
次要结局
- pain medications(post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42)
- edema(post-op days 7, 14, 21, 28, 35, 42)
研究者
研究点 (2)
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