search
Back to results

Collaborative Care for Older Adults With Back Pain (COCOA) (COCOA)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Care
Dual Care
Shared Care
Sponsored by
Palmer College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Genesis Family Medical Center
  • Palmer College of Chiropractic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Medical Care

Dual Care

Shared Care

Arm Description

Conventional medical care alone

Unlinked co-occurrence of conventional medical care and chiropractic care

Co-management of medical care and chiropractic care

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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.
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.
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)

Full Information

First Posted
March 4, 2011
Last Updated
March 8, 2021
Sponsor
Palmer College of Chiropractic
Collaborators
Health Resources and Services Administration (HRSA), Genesis Family Medical Center, University of Iowa, Thomas Jefferson University
search

1. Study Identification

Unique Protocol Identification Number
NCT01312233
Brief Title
Collaborative Care for Older Adults With Back Pain (COCOA)
Acronym
COCOA
Official Title
Co-Management of Older Adults With Low Back Pain by Medical Physicians and Doctors of Chiropractic
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palmer College of Chiropractic
Collaborators
Health Resources and Services Administration (HRSA), Genesis Family Medical Center, University of Iowa, Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Care
Arm Type
Active Comparator
Arm Description
Conventional medical care alone
Arm Title
Dual Care
Arm Type
Active Comparator
Arm Description
Unlinked co-occurrence of conventional medical care and chiropractic care
Arm Title
Shared Care
Arm Type
Active Comparator
Arm Description
Co-management of medical care and chiropractic care
Intervention Type
Other
Intervention Name(s)
Medical Care
Other Intervention Name(s)
Standard Medical Therapies for Back Pain
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dual Care
Other Intervention Name(s)
Medical Care Plus Chiropractic Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Shared Care
Other Intervention Name(s)
Co-managed Medical Care and Chiropractic Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)
Description
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)
Time Frame
Baseline and 3 months
Title
Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ)
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Veterans-RAND 36-item Short-Form Health Survey (VR-36)
Description
Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome.
Time Frame
Baseline and 3 months
Title
Change From Baseline in Bothersomeness of Low Back Pain Symptoms
Description
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.
Time Frame
Baseline to 3 months
Title
Patient Satisfaction With Care
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Goertz, DC, PhD
Organizational Affiliation
Palmer College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Family Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Palmer College of Chiropractic
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Feasibility/pilot study
Citations:
PubMed Identifier
23324133
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.
Results Reference
background
PubMed Identifier
25344427
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.
Results Reference
background
PubMed Identifier
21174032
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.
Results Reference
background
PubMed Identifier
24040970
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.
Results Reference
background
PubMed Identifier
26500355
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.
Results Reference
background
PubMed Identifier
29257708
Citation
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.
Results Reference
background
PubMed Identifier
28082277
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.
Results Reference
background
PubMed Identifier
31257002
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.
Results Reference
background
PubMed Identifier
33062871
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.
Results Reference
background
PubMed Identifier
29029606
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 Geriatr. 2017 Oct 13;17(1):235. doi: 10.1186/s12877-017-0624-z.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4593044/
Description
Collaborative care for a patient with complex low back pain and long-term tobacco use: a case report
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221721/
Description
Eligibility determination for clinical trials: development of a case review process at a chiropractic research center
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3557195/
Description
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
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3847523/
Description
Perspectives of older adults on co-management of low back pain by doctors of chiropractic and family medicine physicians: a focus group study
URL
https://academic.oup.com/gerontologist/article-abstract/doi/10.1093/geront/gnw188/2894401/Interdisciplinary-Practice-Models-for-Older-Adults?redirectedFrom=fulltext
Description
Interdisciplinary Practice Models for Older Adults with Back Pain: A Qualitative Evaluation
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640949/
Description
Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7534140/
Description
Improper communication makes for squat: a qualitative study of the health-care processes experienced by older adults in a clinical trial for back pain

Learn more about this trial

Collaborative Care for Older Adults With Back Pain (COCOA)

We'll reach out to this number within 24 hrs