Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,325
- 试验地点
- 4
- 主要终点
- Duration of low back pain
研究概览
简要总结
We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.
详细描述
Background: Low back pain (LBP) is a musculoskeletal condition that accounts for significant pain and disability, and consumes substantial medical and occupational costs annually. Specific to the United States Armed Forces, LBP was the second most common reason to seek healthcare and affects over 150,000 active duty Soldiers annually (MSMR 2003). Soldiers in the U.S. Army with LBP have the highest risk of disability 5 years after their injury. Furthermore, a military review suggests that LBP was the most common condition bringing about a medical board, with lifetime direct compensation costs estimated to reach into the billions of dollars. Therefore, reduction of disability from LBP is a significant research priority for the military.
Reduction of disability from LBP has been divided into 2 separate phases - primary and secondary prevention. Primary prevention refers to interventions and strategies that are implemented before a low back injury occurs.8 Primary prevention reduces LBP related disability by reducing the total number of people who eventually experience an episode of LBP. Secondary prevention refers to interventions and strategies that are implemented during the acute episode of low back injury, before chronic symptoms occur.9 Secondary prevention reduces LBP related disability by reducing the number of people who eventually experience chronic disability from LBP. We are proposing an innovative approach to LBP prevention by combining primary and secondary prevention strategies that have the potential to limit the development of chronic LBP in Soldiers.
The primary prevention strategy is a core stabilization exercise program (CSEP). The CSEP used in this study has sound biomechanical and anatomical rationale, and has demonstrated its clinical efficacy by preventing future recurrence of LBP. However, this CSEP has not been previously investigated for primary prevention of LBP in healthy Soldiers. The secondary prevention strategy is a psychosocial education program (PSEP). The PSEP used in this study has sound theoretical rationale. It has also demonstrated its clinical efficacy by favorably altering LBP beliefs, as well as limiting the eventual severity of LBP episodes.
These programs (individually or in combination) have not been investigated for prevention of chronic LBP in healthy Soldiers. Therefore, we will train healthy Soldiers in the United States Army in CSEP, PSEP, or combined CSEP/PSEP. We will compare the preventative effects of these exercise and education programs to an already implemented traditional exercise program (TEP).
Objective/Hypothesis: The purpose of this study is to determine if a combined prevention program is more effective at limiting the development of chronic LBP when compared to the effects of individual evidence-based prevention programs, or a traditional exercise program
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 - 35 years old (or emancipated minor)
- •Participating in 91 W (combat medic) MOS training
- •English speaking and reading
排除标准
- •Currently seeking medical care for LBP
- •Previous medical history that includes any surgery for LBP (examples include but are not limited to lumbar fusion, lumbar decompression, and lumbar discectomy)
- •History of degenerative joint disease, arthritis, spine trauma or vertebral fractures, spondylolisthesis, and congenital spine disorders
- •Currently unable to participate in AIT due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
- •History of fracture (stress or traumatic) in proximal femur and/or pelvis
- •Pregnancy (Note: Pregnancy will not result in termination from the study, even though it is an exclusion criteria at enrollment.)
结局指标
主要结局
Duration of low back pain
时间窗: 2 years
Episodes of low back pain
时间窗: 2 years
Severity of low back pain
时间窗: 2 years
次要结局
- Muscle function(12 weeks)
- Beliefs about low back pain(12 weeks)