Care Outcomes for Chiropractic Outpatient Veterans



Status:Active, not recruiting
Conditions:Anxiety, Anxiety, Back Pain, Back Pain, Depression, Psychiatric
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:February 1, 2018
End Date:June 30, 2019

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Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial

The primary objectives of this pilot trial are to evaluate the feasibility, safety and
acceptability of an integrative care pathway that includes chiropractic care, for the
coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP),
with an emphasis on those with mental health comorbidity, in preparation for the conduct of
an appropriately powered multi-site randomized controlled trial (RCT). The secondary
objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and
10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use
in a future RCT; and 3) determine preliminary intervention effect sizes and variability to
aid in sample size determination for a future RCT. The investigators hypothesize that
chiropractic care offers relief for pain and mental health symptoms through the direct
effects of treatment-focused CMT, as well as through the indirect, non-specific effects of
the team-based relationship with the clinician.

This pilot study is a single-arm trial. All participants will be asked to complete study
outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and
interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as
the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale
(GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder
Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool
(STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary
and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life,
General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool
and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability,
mental health, quality of life enjoyment and satisfaction. All participants will receive up
to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and
10 of the study.

The coinciding problems of chronic pain and mental illness are of great concern for patients
seeking care within the Department of Veterans Affairs (VA) healthcare facilities. Of the 5.7
million veterans treated in VA facilities in 2012, more than half reported chronic pain
syndromes, including chronic low back pain (cLBP). Veterans also experience many mental
health comorbidities, such as depression, anxiety, post-traumatic stress disorder (PTSD), and
substance abuse. Veterans in pain are often managed using prescription drugs, including
opioids, psychotropic medications, and sleep agents. Non-pharmacological treatments for
chronic pain, which also may provide relief of mental health symptoms, may be welcomed
complementary therapies for veterans suffering from these conditions.

Patients with musculoskeletal (MSK) pain and pain at multiple locations often report
depression, anxiety and other mental health symptoms. Chronic pain may perpetuate mental
health comorbidity as these conditions share common pathophysiological pathways. Research has
shown that the non-specific effects of empathetic doctor communication and therapeutic
alliance improves clinical outcomes. The investigators hypothesize that chiropractic care
offers relief for pain and mental health symptoms through the direct effects of
treatment-focused chiropractic manipulative therapy (CMT), as well as through the indirect,
non-specific effects of the team-based relationship with the clinician.

However, chiropractic care is not delivered in isolation from other treatments within the VA.
Thus, the investigators will test a feasible, effective, patient-centered, guideline-based,
integrative care model that integrates chiropractic into VA Patient Aligned Care Teams
(PACTs). This integrative care pathway will involve primary care providers, mental health
professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans with
cLBP, with or without mental health comorbidity. While DCs are providing services within VA
in increasing numbers over the past 13 years, as with any new service, adoption and
appropriate placement faces challenges. Many VA providers may know little about the clinical
approaches used by DCs. Similarly, DCs may not be fully aware of the processes involved in
the delivery of primary care services within VA or the healthcare needs of veterans with
mental illness. The purpose of this pilot clinical trial is to evaluate the feasibility,
safety and patient perceptions of an integrative care pathway, developed through a
consensus-based process, for the coordinated care for VA patients with cLBP and mental health
comorbidity.

As this is a pragmatic trial, chiropractic care will consist of usual chiropractic procedures
for the management chronic low back pain (cLBP). Treatment approaches will be based on
clinical evaluation, which may include diagnostic testing, to determine a working diagnosis,
rule out pathology, and/or to screen for conditions requiring referral or other
co-management. The investigators anticipate that chiropractic care often will include some
form of chiropractic manipulative therapy (CMT). DCs will likely also recommend
rehabilitative exercise, stretching, or nutritional and lifestyle advice based upon clinical
findings and patient goals/preferences. The investigators will evaluate treatments through
electronic health records (EHR) data abstraction following completion of chiropractic care at
Week 10. As per typical VA care, DCs will monitor the participant's health status throughout
the trial and initiate referrals as clinically indicated. Referrals to primary care and
mental health providers will be consistent with the chiropractic integrated care pathway
developed during a prior phase of the study. The investigators anticipate the most common
communication and referral methods will occur through note-review and countersign procedures,
which are already established among VA providers using the VA electronic health record, but
may also occur in person or via phone conversations. Chiropractic care will be administered
by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS).

Inclusion Criteria:

- Veterans age 18 years or older

- Self-reported chronic LBP

- Ability to sign informed consent form

Exclusion Criteria:

- Use of chiropractic care within the past 90 days

- Impaired cognitive ability

- Not a candidate for chiropractic care

- Not able to attend chiropractic appointments

- Identified as at risk for suicide
We found this trial at
4
sites
Iowa City, Iowa 52246
Principal Investigator: Thad Abrams, MD, MS
Phone: 319-338-0581
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Coralville, Iowa 52241
Principal Investigator: Thad Abrams, MD, MS
Phone: 319-338-0581
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Davenport, Iowa 52803
Principal Investigator: Christine G Goertz, DC, PhD
Phone: 563-884-5159
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Davenport, IA
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Oskaloosa, Iowa 52577
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Oskaloosa, IA
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