Collaborative Care for Older Adults With Back Pain (COCOA) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Low Back Pain	Other: Medical Care Other: Dual Care Other: Shared Care	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Co-Management of Older Adults With Low Back Pain by Medical Physicians and Doctors of Chiropractic

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:

Patient-Rated Low Back Pain, an 11 point Numerical Rating Scale (NRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Veterans-RAND 36-item Short-Form Health Survey (VR-36) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
Bothersomeness of Low Back Pain Symptoms [ Time Frame: 1 month, 2 months, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
Patient Expectations of Care and Low Back Pain Improvement [ Time Frame: Baseline and Treatment 1 ] [ Designated as safety issue: No ]
Provider Expectations of Care and Low Back Pain Improvement [ Time Frame: Baseline and Treatment 1 ] [ Designated as safety issue: No ]
Patient Satisfaction with Care [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]

Enrollment:	131
Study Start Date:	March 2011
Study Completion Date:	March 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Medical Care Conventional medical care alone	Other: 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. Other Name: Standard Medical Therapies for Back Pain
Active Comparator: Dual Care Unlinked co-occurrence of conventional medical care and chiropractic care	Other: 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. Other Name: Medical Care Plus Chiropractic Care
Active Comparator: Shared Care Co-management of medical care and chiropractic care	Other: 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 Name: Co-managed Medical Care and Chiropractic Care

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312233

Locations

United States, Iowa
Palmer College of Chiropractic
Davenport, Iowa, United States, 52803
Genesis Family Medical Center
Davenport, Iowa, United States, 52803

Sponsors and Collaborators

Palmer College of Chiropractic

Health Resources and Services Administration (HRSA)

Genesis Family Medical Center

University of Iowa

Thomas Jefferson University

Investigators

Principal Investigator:

Christine M Goertz, DC, PhD

Palmer College of Chiropractic

More Information

Publications:

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.

Responsible Party:	Palmer College of Chiropractic
ClinicalTrials.gov Identifier:	NCT01312233 History of Changes
Other Study ID Numbers:	5R18HP15126-02
Study First Received:	March 4, 2011
Last Updated:	April 3, 2013
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013