Collaborative Care for Older Adults With Back Pain (COCOA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Co-Management of Older Adults With Low Back Pain by Medical Physicians and Doctors of Chiropractic

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Medical Care
* Other: Dual Care
* Other: Shared Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical Care<br>Conventional medical care alone | Other: Medical Care<br>* Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.<br>* Other names: Standard Medical Therapies for Back Pain;|
| Active Comparator: Dual Care<br>Unlinked co-occurrence of conventional medical care and chiropractic care | Other: Dual Care<br>* Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.<br>* Other names: Medical Care Plus Chiropractic Care;|
| Active Comparator: Shared Care<br>Co-management of medical care and chiropractic care | Other: Shared Care<br>* Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.<br>* Other names: Co-managed Medical Care and Chiropractic Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS) | 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) | Baseline and 3 months | 
| Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ) | 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. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans-RAND 36-item Short-Form Health Survey (VR-36) | Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome. | Baseline and 3 months | 
| Change From Baseline in Bothersomeness of Low Back Pain Symptoms | Adjusted mean changes in patient-reported LBP bothersomeness on a 5 point scale index (1, not at all bothered; 5, extremely bothered) from baseline to week 12 were assessed. | Baseline to 3 months | 
| Patient Satisfaction With Care | Percent of participants reporting levels of satisfaction for the information received regarding the cause of low back pain [LBP] (A), prognosis of LBP (B) and activities that hasten recovery (C), concern of MDs and Doctor of Chiropractic (DCs) during treatments (D), the quality of the treatment recommendations(E) and the overall care for LBP (F) | 3 months |