Collaborative Care for Older Adults With Back Pain (COCOA)

NCT01312233 | Completed Results DMC

• 1 other identifier: 5R18HP15126-02
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)

  Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible)

  Baseline and 3 months

• Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ)

  Adjusted mean changes in patient-rated disability from baseline to week 12 were assessed using the 24-item RMDQ where 0 indicated no disability and 24 indicated severe disability.

  Baseline and 3 months

Secondary Outcomes (3)

• Veterans-RAND 36-item Short-Form Health Survey (VR-36)

  Baseline and 3 months

• Change From Baseline in Bothersomeness of Low Back Pain Symptoms

  Baseline to 3 months

• Patient Satisfaction With Care

  3 months

Study Arms (3)

Medical Care

ACTIVE COMPARATOR

Conventional medical care alone

Other: Medical Care

Dual Care

ACTIVE COMPARATOR

Unlinked co-occurrence of conventional medical care and chiropractic care

Other: Dual Care

Shared Care

ACTIVE COMPARATOR

Co-management of medical care and chiropractic care

Other: Shared Care

Interventions

Medical Care OTHER

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.

Also known as: Standard Medical Therapies for Back Pain

Medical Care

Dual Care OTHER

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.

Also known as: Medical Care Plus Chiropractic Care

Dual Care

Shared Care OTHER

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.

Also known as: Co-managed Medical Care and Chiropractic Care

Shared Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• Health Resources and Services Administration (HRSA): collaborator
• Genesis Family Medical Center: collaborator
• University of Iowa: collaborator
• Thomas Jefferson University: collaborator

Study Sites (2)

Genesis Family Medical Center

Davenport, Iowa, 52803, United States

Location

Palmer College of Chiropractic

Davenport, Iowa, 52803, United States

Location

Related Publications (10)

• 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.

  PMID: 23324133 BACKGROUND

• 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.

  PMID: 25344427 BACKGROUND

• 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.

  PMID: 21174032 BACKGROUND

• 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.

  PMID: 24040970 BACKGROUND

• 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.

  PMID: 26500355 BACKGROUND

• 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.

  PMID: 29257708 BACKGROUND

• 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.

  PMID: 28082277 BACKGROUND

• 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.

  PMID: 31257002 BACKGROUND

• 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.

  PMID: 33062871 BACKGROUND

• 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.

  PMID: 29029606 RESULT

Related Links

• 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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christine M Goertz, DC, PhD (Study Principal Investigator)
• Organization: Spine Institute for Quality

cgoertz@spineiq.org

301-335-0071

Study Officials

• Christine M Goertz, DC, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 30, 2021
• Results First Posted: March 28, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)