The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduce Calf Muscle Atrophy
研究概览
简要总结
Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing.
The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.
详细描述
The specific aims of this study are to evaluate the use of electrical stimulation on muscle cross-sectional area and muscle fascicle length following post-operative Achilles tendon surgery.
Patients will be randomly assigned to receive an electrical stimulation unit (Compex®, DJO Global, San Diego, CA). Twenty of these units will be experimental and 20 will be sham.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Any patient who is having surgery to treat an acute Achilles tendon rupture or any surgery that involves reflecting or repairing the distal Achilles tendon.
排除标准
- •Body mass index (BMI) greater than or equal to 45
- •Inability to consent to participate in clinical research
- •Any patient younger than 18 years old
- •Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to:
- •Presence of an insulin pump
- •Pacemaker, defibrillators or other implanted electrical device
- •Neurostimulation implants
- •History of epilepsy/seizure
- •Current pregnancy. A pregnancy test will be performed for any female prior to surgical intervention per hospital protocol unless she is post-menopausal or has been sterilized.
- •Active malignancy
- •Peripheral neuropathy
- •Diabetes Mellitus
- •Ischemia of lower limbs
- •Active infection
- •Following acute trauma or fracture
结局指标
主要结局
Reduce Calf Muscle Atrophy
时间窗: Pre-operative, 2 weeks, and 6 weeks post-operative
Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.
次要结局
未报告次要终点
研究者
Christopher Hyer
DPM, MS
Orthopedic Foot and Ankle Center, Ohio