Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- FACES Pain Rating Scale
研究概览
简要总结
The primary objective of this study is to assess whether or not low level laser therapy (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.
详细描述
Lumbar fusion surgery patients typically experience significant post-operative pain for several weeks and their rehabilitation does not start until 8 - 12 weeks postoperatively. We hypothesize that LLLT beginning 4 weeks postoperatively will provide significant reduction in postoperative pain.
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
- None
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
- •Age > 18 and < 85 years
- •Post-operative lumbar fusion surgery
- •Currently resides within 100 miles of UMC
排除标准
- •Pacemaker
- •Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
- •Two or more cardiac risk factors
- •Intraoperative complications
- •Wound infection
- •Spinal fluid leakage
- •Open wound
结局指标
主要结局
FACES Pain Rating Scale
时间窗: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Oswestry Low Back Pain Disability (ODQ) Questionnaire
时间窗: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
Quality of Life - The Quality of Life Short-Form Survey (SF-36)
时间窗: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
次要结局
- Improvement measured by serial photographs of surgery appearance and rate of healing(2 weeks after surgery, then 6, 12, and 24 weeks after surgery)
- Pain medication usage(baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline)