The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in disability score
研究概览
简要总结
Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related disability.
While there is growing evidence for the clinical effectiveness of alternative and complementary therapies to treat low back pain, little is known on the physiologic consequences and effects of these treatments. Further, additional data is needed to understand how these different treatment techniques effect clinical changes in pain and disability. The lack of empirical data hinders acceptance by the wider scientific and health-care communities, and it also limits the development of rational strategies for using alternative and complementary therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Report history consistent with chronic low back pain
- •Average pain intensity at least mild when assessed with a numerical pain scale
- •At least mild disability when assessed with a questionnaire
- •Meets criteria for clinical prediction rule
排除标准
- •A history of certain neurological, cardiorespiratory, and musculoskeletal disorders
- •Have active cancer or be blind
- •Report recent use of certain medications and treatments
- •Report being pregnant, lactating, or that she anticipates becoming pregnant in the next 3-months
- •Have too high body mass or unexplained weight loss
- •Have clinical depression
- •Have pending litigation related to the low back pain or are receiving any type of disability services
- •Current drug or alcohol use that would interfere with adherence to study requirements
研究组 & 干预措施
Manipulation
Spinal manipulation
干预措施: Manipulation (Other)
Mobilization
Spinal mobilization
干预措施: Mobilization (Other)
Laser Therapy
Cold laser therapy
干预措施: Laser Therapy (Other)
结局指标
主要结局
Change in disability score
时间窗: 48 hours post 3 week intervention
Roland Morris disability questionnaire
Change in numerical pain rating score
时间窗: 48 hours post 3 week intervention
次要结局
- Change in score on PROMIS Pain Behavior Survey(48 hours post 3 week intervention)
- Change in scores on PROMIS pain interference survey(48 hours post 3 week interventions)
- Change in scores on PROMIS physical function survey(48 hours post 3 week intervention)
- Change in scores on PROMIS pain intensity survey(48 hours post 3 week intervention)