Collaborative Care for Older Adults With Back Pain (COCOA)

Low Back Pain Clinical Trial

— COCOA  

Official title:

Co-Management of Older Adults With Low Back Pain by Medical Physicians and Doctors of Chiropractic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312233
• Other study ID #: 5R18HP15126-02
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2021
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Genesis Family Medical Center	Davenport	Iowa
United States	Palmer College of Chiropractic	Davenport	Iowa

Sponsors (5)

Lead Sponsor	Collaborator
Palmer College of Chiropractic	Genesis Family Medical Center, Health Resources and Services Administration (HRSA), Thomas Jefferson University, University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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 Geriat — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Veterans-RAND 36-item Short-Form Health Survey (VR-36)	Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome.	Baseline and 3 months
Secondary	Change From Baseline in Bothersomeness of Low Back Pain Symptoms	Adjusted mean changes in patient-reported LBP bothersomeness on a 5 point scale index (1, not at all bothered; 5, extremely bothered) from baseline to week 12 were assessed.	Baseline to 3 months
Secondary	Patient Satisfaction With Care	Percent of participants reporting levels of satisfaction for the information received regarding the cause of low back pain [LBP] (A), prognosis of LBP (B) and activities that hasten recovery (C), concern of MDs and Doctor of Chiropractic (DCs) during treatments (D), the quality of the treatment recommendations(E) and the overall care for LBP (F)	3 months

External Links

•   Collaborative care for a patient with complex low back pain and long-term tobacco use: a case report
•   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
•   Eligibility determination for clinical trials: development of a case review process at a chiropractic research center
•   Improper communication makes for squat: a qualitative study of the health-care processes experienced by older adults in a clinical trial for back pain
•   Interdisciplinary Practice Models for Older Adults with Back Pain: A Qualitative Evaluation
•   Interprofessional Attitudes and Interdisciplinary Practices for Older Adults With Back Pain Among Doctors of Chiropractic: A Descriptive Survey
•   Patient-centered professional practice models for managing low back pain in older adults: a pilot 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