Assessment of Infrared Photobiotherapy for Improved Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- FACES Pain Rating Scale Scores
研究概览
简要总结
The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).
详细描述
This is a prospective, two group, controlled study using random assignment. All eligible patients will be randomly assigned to one of two groups: the control group (usual care) or the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study: 25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group.
All subjects will be recruited within one to two days prior to hospital discharge or at the time of their first postoperative clinic visit. No subjects will be recruited while sedated or receiving intravenous pain medication.
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
- •Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)
- •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
- •Open Wound
结局指标
主要结局
FACES Pain Rating Scale Scores
时间窗: 6 weeks after surgery
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
FACES Pain Rating Scale.
时间窗: 12 weeks after surgery
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
次要结局
- 36-Item Short Form Survey - Bodily Pain Scores(6 weeks after surgery)
- 36-Item Short Form Survey - Bodily Pain Scale(12 weeks after surgery)
- 36-Item Short Form Survey - General Health(12 weeks after surgery)
- 36-Item Short Form Survey - Physical Function(12 weeks after surgery)
- 36-Item Short Form Survey - Mental Health(12 weeks after surgery)
- 36-Item Short Form Survey - Social Function(12 weeks after surgery)
研究者
Martin Skie, MD
Principal Investigator
University of Toledo Health Science Campus