Chiropractic and Self-care for Back-Related Leg Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- Patient-rated leg pain
研究概览
简要总结
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.
Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Back-related leg pain > 3 on 0 to 10 scale.
- •Sub-acute or chronic back-related leg pain defined as current episode > 4 weeks duration.
- •Back-related leg pain classified as 2, 3, 4, or 6 using the Quebec Task Force (QTF) Classification system. This includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root.
- •21 years of age and older.
- •Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).
排除标准
- •Ongoing treatment for leg or low back pain by other health care providers.
- •Progressive neurological deficits or cauda equina syndrome.
- •QTF classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
- •QTF 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
- •Uncontrolled hypertension or metabolic disease.
- •Blood clotting disorders.
- •Severe osteoporosis.
- •Inflammatory or destructive tissue changes of the spine.
- •Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of low back pain patients which generally have a poorer prognosis.
- •Pregnant or nursing women.
- •Current or pending litigation. Patients seeking financial compensation tend to respond differently to treatment.
结局指标
主要结局
Patient-rated leg pain
时间窗: short-term = 12 weeks; long-term = 52 weeks
次要结局
- Disability(short-term = 12 weeks; long-term = 52 weeks)
- Fear Avoidance(short-term = 12 weeks; long-term = 52 weeks)
- Patient Satisfaction(short-term = 12 weeks; long-term = 52 weeks)
- Improvement(short-term = 12 weeks; long-term = 52 weeks)
- Medication Use(short-term = 12 weeks; long-term = 52 weeks)
- Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance(short-term = 12 weeks)
- Bothersomeness(short-term = 12 weeks; long-term = 52 weeks)
- General Health Status(short-term = 12 weeks; long-term = 52 weeks)
- Frequency(short-term = 12 weeks; long-term = 52 weeks)