Collaborative Care for Older Adults With Back Pain (COCOA)
NCT ID: NCT01312233
Last Updated: 2021-03-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2011-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Medical Care
Conventional medical care alone
Medical Care
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.
Dual Care
Unlinked co-occurrence of conventional medical care and chiropractic care
Dual Care
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.
Shared Care
Co-management of medical care and chiropractic care
Shared Care
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.
Interventions
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Medical Care
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.
Dual Care
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.
Shared Care
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Health Resources and Services Administration (HRSA)
FED
Genesis Family Medical Center
UNKNOWN
University of Iowa
OTHER
Thomas Jefferson University
OTHER
Palmer College of Chiropractic
OTHER
Responsible Party
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Principal Investigators
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Christine M Goertz, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
Palmer College of Chiropractic
Locations
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Genesis Family Medical Center
Davenport, Iowa, United States
Palmer College of Chiropractic
Davenport, Iowa, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Collaborative care for a patient with complex low back pain and long-term tobacco use: a case report
Eligibility determination for clinical trials: development of a case review process at a chiropractic research center
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
Perspectives of older adults on co-management of low back pain by doctors of chiropractic and family medicine physicians: a focus group study
Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial
Improper communication makes for squat: a qualitative study of the health-care processes experienced by older adults in a clinical trial for back pain
Other Identifiers
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5R18HP15126-02
Identifier Type: -
Identifier Source: org_study_id
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