Individualized Chiropractic and Integrative Care for Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Patient-rated back pain.
研究概览
简要总结
This study proposes to compare two innovative treatment approaches for LBP, both of which focus on delivering individualized care through evidence-based, clinical care pathways.
The primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure in this study is patient-rated back pain.
Chiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education.
Secondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term.
This innovative study is an exciting collaboration between an experienced and established team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of pervasive and costly LBP conditions. This trial will provide new and important information for all health care providers and LBP patients, informing decision making and improving care delivery systems.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical LBP classified as 1, 2, 3, or 4 using Quebec Task Force (QTF) classification.70 (This includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs).
- •LBP localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds.
- •Pain level > 3 on 0 to 10 scale
- •Current LBP episode > 6 weeks duration
- •18 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 LBP by other non-study providers
- •Progressive neurological deficits or cauda equina syndrome
- •QTF classifications 5 (spinal instability or 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 LBP patients which generally have a poorer prognosis.
- •Pregnant or nursing women
结局指标
主要结局
Patient-rated back pain.
时间窗: Short term: 12 weeks, Long term: 52 weeks
次要结局
- Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.(Short term: 12 weeks)
- Frequency of Symptoms(12 and 52 weeks)
- Low Back Disability(12 and 52 weeks)
- Fear Avoidance(12 and 52 weeks)
- Self-Efficacy(12 and 52 weeks)
- General Health Status(12 and 52 weeks)
- Improvement(12 and 52 weeks)
- Patient Satisfaction(12 and 52 weeks)
- Work Loss(12 and 52 weeks)
- Medication Use(12 and 52 weeks)