Co-Management of Older Adults With Low Back Pain by Medical Physicians and Doctors of Chiropractic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)
研究概览
简要总结
The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration.
详细描述
As America ages, cost-effective care for chronic diseases, such as low back pain, becomes more important. Although estimates vary, 70-85% of Americans will suffer from back pain at some point in their lives. Back pain is well established as one of the most common reasons for seeking care from a medical doctor. The American public also turns to alternative medicine providers, such as doctors of chiropractic, for back pain care. However, few clinical examples and little scientific evidence exist of care coordination between these two provider groups in general, and none that specifically target older adults above the age of 65. The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration. Participants will be randomized to 3-parallel treatment arms: a) conventional medical care (MED CARE), b) unlinked conventional medical and chiropractic care (DUAL CARE), and c) a co-management model including conventional medical and chiropractic care (SHARED CARE). Participants in all three groups will receive up to 12 weeks of usual back pain treatment from medical doctors or doctors of osteopathy (MD/DO) at Genesis Family Medical Center. Participants in two treatment groups additionally will receive up to 12 weeks of usual chiropractic care for back pain from doctors of chiropractic at the Palmer Research Clinic. Outcomes including pain, disability and secondary outcomes will be measured at 1, 2, and 3 months (primary endpoint) with follow-up assessments completed by telephone at 6, 9, and 12 months.
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 (Investigator)
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
- •Age 65 years or older
- •Low back pain ≥4 on the 11-point Numerical Rating Scale
- •Low back pain diagnosis consistent with Quebec Task Force (QTF) Classifications 1-9
- •Ambulatory mobility status per successful completion of the Timed Up & Go Test
- •Willingness to participate in this clinical trial regardless of treatment group assignment
排除标准
- •No history or current episode of low back pain
- •Low back pain duration of less than 1 month
- •Low back pain diagnosis consistent with Quebec Task Force Classification of 10 or 11
- •Any healthcare provider treatment for low back pain in past 2 months
- •Currently seeking or receiving compensation for a work-related injury or personal injury case for low back pain
- •Currently seeking or applying for disability payments for any health condition
- •Spine or neck surgery in the past 3 months
- •Broken bone in any location in the body in the past 6 weeks
- •Active carcinoma/metastatic disease or current treatment for any form of cancer
- •Aortic aneurysm (or suspicion of) >5cm
- •Serious concomitant illness or co-morbidity
- •Alcohol or drug abuse or dependence
- •Need for laboratory testing, diagnostic imaging beyond plain film x-rays or referral to a healthcare provider not associated with the study to determine a diagnosis or for necessary treatment
- •Activities of daily living (ADL), mobility impairment or sensory impairment that impacts safety
- •Cognitive or memory impairment
- •Compliance concerns
- •Nursing home residence
- •No reliable transportation
- •Plans to move from Quad-Cities in the next 4 months
- •Pregnancy or plans to become pregnant in next 4 months in a female participant
- •Enrollment in this study by another individual who currently lives in the same household as the participant
- •Inability to speak (verbally comprehend), read or write in English language
- •Unwillingness to avoid all forms of low back pain treatment from non-study medical doctors and chiropractors during study participation
- •Unwillingness to enroll in clinical trial regardless of treatment group assignment
- •Unwillingness to sign informed consent document
- •Current student, employee or faculty member of the Palmer College of Chiropractic or Genesis Family Medical Center
结局指标
主要结局
Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)
时间窗: Baseline and 3 months
Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible)
Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ)
时间窗: Baseline and 3 months
Adjusted mean changes in patient-rated disability from baseline to week 12 were assessed using the 24-item RMDQ where 0 indicated no disability and 24 indicated severe disability.
次要结局
- Veterans-RAND 36-item Short-Form Health Survey (VR-36)(Baseline and 3 months)
- Change From Baseline in Bothersomeness of Low Back Pain Symptoms(Baseline to 3 months)
- Patient Satisfaction With Care(3 months)