Care Outcomes for Chiropractic Outpatient Veterans
Completed · Not applicable
Conditions studied: Low Back Pain, PTSD, Depression, Anxiety
In brief
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.
Key facts
- Study ID
- NCT03254719
- Run by
- Palmer College of Chiropractic
- People needed
- 40
- Starts
- 2018-02-19
- Expected to finish
- 2018-11-05
- Last updated by the study team
- 2020-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans age 18 years or older
- Self-reported chronic LBP
- Ability to sign informed consent form
You may not qualify if…
- 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
Where it is running
- VA Community Based Outpatient Clinic — Coralville, Iowa, United States
- Palmer Center for Chiropractic Research — Davenport, Iowa, United States
- Iowa City Veterans Affairs Health Care System — Iowa City, Iowa, United States
- The Spine Institute for Quality — Oskaloosa, Iowa, United States
Full record on ClinicalTrials.gov
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