Elderly Back Pain: Comparing Chiropractic to Medical Care
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
- Roland Morris Disability Questionnaire(RMDQ).
研究概览
简要总结
The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic low back pain (LBP).
详细描述
Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with pack pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 or older
- •Idiopathic low back pain (LBP) of at least four weeks duration
- •Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders
排除标准
- •Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis.
- •Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse.
- •Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition
- •Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis
- •Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory
- •Current or pending litigation related to current episode of LBP.
- •Receiving disability for any health-related condition
- •Spinal Manipulative care for any reason within the past month
- •Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period.
- •Unable to read or verbally comprehend English.
研究组 & 干预措施
HVLA-SM
High-velocity low amplitude spinal manipulation (HVLA-SM)
干预措施: HVLA-SM (Other)
LVVA-SM
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
干预措施: LVVA-SM (Other)
Usual Medical Care
Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)
干预措施: Usual medical care (Drug)
结局指标
主要结局
Roland Morris Disability Questionnaire(RMDQ).
时间窗: 6 weeks
次要结局
- Postural Sway(6 weeks)
- SF-36, v1, Physical Function subscale(6 weeks)
- Posteroanterior Spinal Stiffness(6 weeks)
- Sit-to-Stand Maneuver(6 weeks)
- Spinal Manipulation(6 weeks)
- Fear Avoidance Beliefs Questionnaire, physical subscale(6 weeks, 3 months, 6 months)
- Visual Analogue Scale for Pain(6 weeks)