Clinical trial NCT01312233: Collaborative Care for Older Adults With Back Pain (COCOA)
Official title: Co-Management of Older Adults With Low Back Pain by Medical Physicians and Doctors of Chiropractic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Genesis Family Medical Center
name: University of Iowa
name: Thomas Jefferson University
First posted: 2011-03-10
Enrollment: 131
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)
timeFrame: Baseline and 3 months
measure: Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Veterans-RAND 36-item Short-Form Health Survey (VR-36)
timeFrame: Baseline and 3 months
measure: Change From Baseline in Bothersomeness of Low Back Pain Symptoms
timeFrame: Baseline to 3 months
measure: Patient Satisfaction With Care
timeFrame: 3 months
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Genesis Family Medical Center
state: Iowa
city: Davenport
country: United States
facility: Palmer College of Chiropractic
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: Christine M Goertz, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goertz CM, Salsbury SA, Vining RD, Long CR, Andresen AA, Jones ME, Lyons KJ, Hondras MA, Killinger LZ, Wolinsky FD, Wallace RB. Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial. Trials. 2013 Jan 16;14:18. doi: 10.1186/1745-6215-14-18.
citation: Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406.
citation: Goertz C, Lyons SS, Andresen A, Hondras M, Jones M, Killinger LZ, Long C, Lyons K, Mulhausen P, Vining R. Collaborative Care for Older Adults (COCOA), Palmer College of Chiropractic. J Allied Health. 2010 Fall;39 Suppl 1:e135-6.
citation: Lyons KJ, Salsbury SA, Hondras MA, Jones ME, Andresen AA, Goertz CM. Perspectives of older adults on co-management of low back pain by doctors of chiropractic and family medicine physicians: a focus group study. BMC Complement Altern Med. 2013 Sep 16;13:225. doi: 10.1186/1472-6882-13-225.
citation: Seidman MB, Vining RD, Salsbury SA. Collaborative care for a patient with complex low back pain and long-term tobacco use: a case report. J Can Chiropr Assoc. 2015 Sep;59(3):216-25.
citation: Boysen JC, Shannon ZK, Khan YA, Wells BM, Vining RD. A graphical clinical decision aid for managing imaging report information. J Chiropr Educ. 2017 Mar;32(1):43-49. doi: 10.7899/JCE-17-6. Epub 2017 Dec 19.
citation: Salsbury SA, Goertz CM, Vining RD, Hondras MA, Andresen AA, Long CR, Lyons KJ, Killinger LZ, Wallace RB. Interdisciplinary Practice Models for Older Adults With Back Pain: A Qualitative Evaluation. Gerontologist. 2018 Mar 19;58(2):376-387. doi: 10.1093/geront/gnw188.
citation: Salsbury SA, Vining RD, Hondras MA, Wallace RB, Lyons KJ, Killinger LZ, Goertz CM. Interprofessional Attitudes and Interdisciplinary Practices for Older Adults With Back Pain Among Doctors of Chiropractic: A Descriptive Survey. J Manipulative Physiol Ther. 2019 May;42(4):295-305. doi: 10.1016/j.jmpt.2018.11.011. Epub 2019 Jun 27.
citation: Wells BM, Salsbury SA, Nightingale LM, Derby DC, Lawrence DJ, Goertz CM. Improper Communication Makes for Squat: A Qualitative Study of the Health-Care Processes Experienced By Older Adults in a Clinical Trial for Back Pain. J Patient Exp. 2020 Aug;7(4):507-515. doi: 10.1177/2374373519860347. Epub 2019 Jul 8.
citation: Goertz CM, Salsbury SA, Long CR, Vining RD, Andresen AA, Hondras MA, Lyons KJ, Killinger LZ, Wolinsky FD, Wallace RB. Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial. BMC Geriatr. 2017 Oct 13;17(1):235. doi: 10.1186/s12877-017-0624-z.