Collaborative Care for Older Adults With Back Pain (COCOA)

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Genesis Family Medical Center
University of Iowa
Thomas Jefferson University
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01312233
First received: March 4, 2011
Last updated: April 3, 2013
Last verified: April 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014