N/A
Completed N=40
Care Outcomes for Chiropractic Outpatient Veterans
Source: ClinicalTrials.gov NCT03254719 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Duration of Study Recruitment — 6 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Study Recruitment |
6 | — |
| PRIMARY Diversity of Patient Demographics |
1; 36; 3; 2; 31; 6 | — |
| PRIMARY Number of Participants Engaged in Use of MyHealthEVet |
15 | — |
| PRIMARY Acceptability |
10; 9; 5 | — |
| PRIMARY Number of Participants With Reported Adverse Events |
6 | — |
| PRIMARY Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up |
8 | — |
| SECONDARY Roland Morris Low Back Pain Disability Questionnaire (RMDQ) |
12.9; 10.2; 9.6 | — |
| SECONDARY Pain Assessment Screening Tool and Outcomes Registry (PASTOR) |
6.4; 5.7; 5.3; 5.4; 4.8; 3.9 | — |
| SECONDARY STarT Back Screening Tool |
2; 17; 13; 8; 9; 12 | — |
| SECONDARY Self-Efficacy for Managing Symptoms (SF8a) |
41.6; 43.5 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
9.7; 8.6 | — |
| SECONDARY Generalized Anxiety Disorder-7 (GAD-7) |
7.7; 6.8 | — |
| SECONDARY Alcohol Use Disorders Identification Test (AUDIT) |
2.2; 1.7 | — |
| SECONDARY PTSD Checklist-Civilian (PCL-C) |
40.3; 40.1 | — |
| SECONDARY Healing Encounters and Attitudes Lists (HEAL) |
60.9; 54.4; 54.6; 52.0; 50.9; 56.0 | — |
| SECONDARY Pain, Enjoyment, and General Activity (PEG) |
5.1; 4.8; 5.3; 4.7; 5.2; 4.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03254719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.