Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.
详细描述
Tibial stress reactions and fractures are often difficult to treat, and therefore, many soldiers proceed to a medical disability/discharge. It is felt that with the use of the MIRE technology, active duty soldiers with tibial stress reactions and fractures will heal more quickly and completely. All soldiers will have a documented bone scintigraph as evidence for tibial stress reaction or fracture prior to enrollment. In addition, pain-pressure goniometric measures and time to complete the Balke protocol will also be used to assess healing with the MIRE technology.
Comparison: Soldiers with Active MIRE technology, compared to soldiers with Placebo MIRE technology.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active duty soldier
- •Exertional leg pain of greater than 3 months duration
- •Documented bone scintigraphic evidence for tibial stress reaction or fracture
排除标准
- •Known leg Pathology other than stress reaction or fracture
- •Service members known to be leaving area within next 6 months
- •Pregnant females
- •High risk cardiopulmonary patients
- •Patients with assisted walking devices
- •Patients with two or more cardiac risk factors
结局指标
主要结局
Visual Analog Scale
时间窗: 4 weeks
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
次要结局
未报告次要终点