This clinical trial compares the effects of chiropractic care added to usual medical care vs usual medical care alone on pain relief and pain-related function among active-duty US military personnel.
BACKGROUND: Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. METHODS: The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. RESULTS: Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized ...
This study examines Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v1.0 outcomes of chiropractic care in a multi-site, pragmatic clinical trial and compares the PROMIS measures to: 1) worst pain intensity from a numerical pain rating 0-10 scale, 2) 24-item Roland-Morris Disability Questionnaire (RMDQ); and 3) global improvement (modified visual analog scale). A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC). 3 military treatment facilities. 750 active-duty military personnel with low back pain. Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change. We found statistically significant mean group differences favoring UMC+CC for all PROMIS®-29 scales and the RMDQ score. Area under the curve estimates for global improvement for the PROMIS®-29 scales and the RMDQ, ranged from 0.79 to 0.83. Findings from this pre-planned secondary analysis demonstrate that chiropractic care impacts health-related quality of life beyond pain and pain-related disability. Further, comparable findings were found between the 24-item RMDQ and the PROMIS®-29 v1.0 briefer scales.