Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Visual Analog Score (VAS) for pain
研究概览
简要总结
The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction (ACLR), and thus residual opioids in circulation.
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
- Single (Outcomes Assessor)
盲法说明
Blinded data will be provided to the statistician w/o reference to specific treatment arms
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Underwent ACL reconstruction
排除标准
- •Pediatric iliotibial band ACL reconstruction (known to cause significantly more pain)
- •Non-english speakers (limitations of our study group)
研究组 & 干预措施
Standard Ice packs
Standard ice packs applied to knee for 20 minutes a day three times a day
干预措施: Standard ice packs (Device)
Cryocompression device
Cryocompression device (Game Ready, Bregs) with ice placed into the device and applied to knee for 20 minutes a day, three times a day
干预措施: Cryocompression (Game Ready, Bregs) device (Device)
VibraCool
FDA-approved VibraCool mechanical stimulation and neuromodulatory therapeutic device with ice placed into it and applied to knee for 20 minutes a day, three times a day
干预措施: VibraCool mechanical stimulation and neuromodulatory therapeutic device (Device)
结局指标
主要结局
Visual Analog Score (VAS) for pain
时间窗: First 7 post-operative days
Scale of 0 to 10, with 10 being the worst pain and 0 being no pain. Will record daily mean VAS pain scores over the first seven post-operative days
Opioid use
时间窗: First 3 post-operative days
Percent of patients discontinuing opioid use by or on post-operative day three, compared to those who continue after day three
次要结局
- Mean reduction in opioid use in mg of morphine equivalents per day(First 7 post-operative days)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score(First 7 post-operative days)
研究者
Lauren H. Redler
Assistant Professor of Orthopedic Surgery
Columbia University