Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Patient-rated pain (0-11 box scale)
研究概览
简要总结
The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
详细描述
Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health.
The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT.
This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain.
PRIMARY AIMS
- To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.)
- •Quebec Task Force classifications 1, 2, 3 and
- •(This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570})
- •65 years of age and older
- •Independent ambulation
- •Community dwelling (residency outside nursing home)
- •Score of 20 or more on Folstein Mini-Mental State Examination{13246}
- •Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)
排除标准
- •Referred low back pain from local joint lesions of the lower extremities or from visceral diseases
- •Significant infectious disease Determined by history or by referral to supplementary diagnostic tests
- •Ongoing treatment for low back pain by other health care providers
- •Mean baseline low back pain score of 20 percentage points or less
- •Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease
- •Contraindications to spinal manipulation (i.e. Progressive neurological deficits blood clotting disorders; infectious and non-infectious inflammatory or destructive tissue changes of the spine; severe osteoporosis)
结局指标
主要结局
Patient-rated pain (0-11 box scale)
时间窗: short term = 12 weeks; long term = 52 weeks
次要结局
- Improvement(short term = 12 weeks; long term = 52 weeks)
- General Health(short term = 12 weeks; long term = 52 weeks)
- Disability(short term = 12 weeks; long term = 52 weeks)
- Satisfaction(short term = 12 weeks; long term = 52 weeks)
- Medication use(short term = 12 weeks; long term = 52 weeks)
- Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior(short term = 12 weeks)