Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial

Ron D Hays, Zacariah K Shannon, Cynthia R Long, Karen L Spritzer, Robert D Vining, Ian D Coulter, Katherine A Pohlman, Joan A Walter, Christine M Goertz, Ron D Hays, Zacariah K Shannon, Cynthia R Long, Karen L Spritzer, Robert D Vining, Ian D Coulter, Katherine A Pohlman, Joan A Walter, Christine M Goertz

Abstract

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.

Figures

Figure 1.
Figure 1.
CONSORT flow diagram.
Figure 2.
Figure 2.
Area under the curve for change in Roland-Morris overall score by change in PROMIS®-29 physical function scale from baseline to 6 weeks later.
Figure 3.
Figure 3.
Area under the curve for change in Roland-Morris overall score by change in worst pain intensity (last 24 hours) from baseline to 6 weeks later.
Figure 4.
Figure 4.
Area under the curve for change in Roland-Morris overall score by change in PROMIS®-29 pain interference scale from Baseline to 6 weeks later.
Figure 5.
Figure 5.
Area under the curve for change in Roland-Morris overall score by change in PROMIS®-29 pain intensity item from Baseline to 6 weeks later.
Figure 6.
Figure 6.
Area under the curve for global improvement by change in PROMIS®-29 pain intensity item from baseline to 6 weeks later.
Figure 7.
Figure 7.
Area under the curve for global improvement by change in Roland-Morris scale from baseline to 6 weeks later.
Figure 8.
Figure 8.
Area under the curve for global improvement by change in worst pain intensity (last 24 hours) from baseline to 6 weeks later.
Figure 9.
Figure 9.
Area Under the Curve for Global Improvement by Change in PROMIS®-29 pain interference scale from Baseline to 6 weeks later.
Figure 10.
Figure 10.
Area under the curve for global improvement by change in PROMIS®-29 physical function scale from baseline to 6 weeks later.

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