Collaborative Care for Older Adults With Back Pain (COCOA)

Not Applicable

Completed

Conditions: Low Back Pain

Interventions: Other: Medical Care
Other: Dual Care
Other: Shared Care

Registration Number: NCT01312233

Lead Sponsor: Palmer College of Chiropractic

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 131

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Care	Medical Care	Conventional medical care alone
Dual Care	Dual Care	Unlinked co-occurrence of conventional medical care and chiropractic care
Shared Care	Shared Care	Co-management of medical care and chiropractic care

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Veterans-RAND 36-item Short-Form Health Survey (VR-36)	Baseline and 3 months	Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome.
Change From Baseline in Bothersomeness of Low Back Pain Symptoms	Baseline to 3 months	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.
Patient Satisfaction With Care	3 months	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)