Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Neck Disability Index (NDI)
研究概览
简要总结
Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.
详细描述
The purpose of this study is to identify what are the most effective low level laser therapy (LLLT) dosimetry parameters when treating pilots and navigators complaining of flight related neck pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
- •Inclusion Criteria:
- •Active Duty US Air Force pilots or onboard navigators, aged 18- 62 years of age
- •maintain operational flight status at enrollment or within the last 6 months
- •History of neck pain for a period of more than two months
- •Score on the Neck Disability Index ranging from 15-24
- •No physiotherapy or local injection in 3 months before starting the study
排除标准
- •major surgery or trauma in the previous 3 months
- •unstable cervical spine
- •cervical radiculopathy
- •rheumatoid arthritis
- •open wound over neck
- •pace-maker or defibrillator implantation
- •overt neuropathic pain or radiation pain
- •inability to express pain or quality of life.
- •history of neurological disorders
- •medical diagnosis of fibromyalgia; systemic disease
结局指标
主要结局
Change in Neck Disability Index (NDI)
时间窗: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
The NDI assessing functional capacity, has 10 parts, which evaluate pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping, and recreation. NDI scores, ranging from 0-50, may be doubled and also expressed as a percentage of function on a scale of 0-100%; thereby allowing the measure to be treated as an interval variable. It has also been categorized into 5 ordinal measurements, which are shown below with corresponding score and percentage measurements: * NDI Score 0-4 (0-8%) is total capacity (no disability) * NDI Score 5-14 (10-28%) is mild incapacity (mild disability) * NDI Score 15-24 (30-48%) is mild incapacity (moderate disability) * NDI Score 25-34 (50-64%) is serious capacity (severe disability) * NDI Score 35-50 (70-100%) is severe incapacity (complete disability)
Change in Defense and Veterans Pain Rating Scale (DVPRS)
时间窗: visit 0 (screening visit), visit 1 (day 1), visit 10 (day 10)
The Defense and Veterans Pain Rating Scale is an assessment tool that utilizes a numerical rating scale, enhanced by functional word descriptors, color coding, and graphical facial expressions to evaluate a patient's self-reported pain levels. The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.
Number of grounding days from flying due to neck pain -- Interval Variable
时间窗: Record during screening visit
Number of grounding days from flying due to neck pain -- Interval Variable
次要结局
- Change in Interleukin 12 biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 6 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in substance P Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in alpha-1 antitrypsin Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in C-reactive protein Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 4 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 13 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 8 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 5 biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 2 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in cyclooxygenase (COX-2 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in cortisol Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 2 Receptor (CD25) Soluble Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 10 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 17 Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Interleukin 1 beta Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
- Change in Tumor Necrosis Factor - alpha Biomarker Levels(day 0 (pre-treatment), day 10 (post-treatment))
研究者
Paul Crawford
Principal Investigator
Mike O'Callaghan Military Hospital