N/A
N=131
Collaborative Care for Older Adults With Back Pain (COCOA)
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01312233 ↗Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS) — 1.8; 3.0; 2.3; 2.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medical Care (Other); Dual Care (Other); Shared Care (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Palmer College of Chiropractic
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS) |
1.8; 3.0; 2.3; 2.1; 2.9; 2.3 | — |
| PRIMARY Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ) |
2.8; 2.5; 1.5 | — |
| SECONDARY Veterans-RAND 36-item Short-Form Health Survey (VR-36) |
50.0; 57.8; 65.0; 58.8; 63.8; 65.6 | — |
| SECONDARY Change From Baseline in Bothersomeness of Low Back Pain Symptoms |
0.8; 0.9; 0.6 | — |
| SECONDARY Patient Satisfaction With Care |
1; 0; 7; 2; 2; 4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01312233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.