Objective: 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).
Design: A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC).
Setting: Three military treatment facilities.
Subjects: 750 active-duty military personnel with low back pain.
Methods: Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change.
Results: 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.
Conclusions: 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.
Keywords: Chiropractic Care; Clinical Trial; Health-Related Quality Of Life; Low Back Pain; Military; PROMIS®; Patient Outcome Assessment; Usual Medical Care.
© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.