CHANGES IN PROMIS GLOBAL PHYSICAL AND MENTAL HEALTH FOLLOWING A 21-DAY INTEGRATED AYURVEDA YOGA PROGRAM FOR LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMISED CONTROLLED TRIAL

Abstract

Background: Low back pain affects pain, physical function, participation, emotional well-being and perceived overall health. Disease-specific outcomes such as pain and disability may not fully capture changes in global health. PROMIS Global Health provides standardised summary measures of Global Physical Health (GPH) and Global Mental Health (GMH). Objective: To examine changes in PROMIS GPH and GMH following a 21-day integrated program of alignment-oriented Yoga, Kukundara Marma self-mobilisation and selected Swasthavritta practices compared with a structured lifestyle modification program in adults with low back pain. Methods: This secondary analysis used data from a two-arm parallel-group randomised controlled trial. Two hundred and ninety adults aged 18–50 years were randomised equally to the integrated program (n=145) or lifestyle-modification control (n=145). PROMIS Global-10 was assessed at baseline (Day 1), immediately after intervention (Day 21), and follow-up (Day 61). The principal outcomes were GPH and GMH. We used between-group comparisons, baseline adjusted ANCOVA, and linear mixed-effects models. The original analysis was performed on the raw 4–20 summary score metric, with T-scores additionally reported. Results: Baseline GPH and GMH were similar between groups. Mean GPH T-score increased from 34.30 at baseline to 46.70 at Day 21 and 49.42 at Day 61 in the integrated group, compared with 34.33, 36.35 and 38.13 in controls. The between-group difference in change was 10.59 T-score points at Day 21 and 11.31 at Day 61 (both p<0.001). GMH T score increased from 41.71 to 49.41 and 52.86 in the integrated group, versus 42.08, 42.58 and 44.63 in controls. The between-group difference in change was 7.12 points at Day 21 and 8.36 at Day 61 (both p<0.001). In raw-score mixed models, group-by-time interactions were 3.92 and 4.07 points for GPH and 2.90 and 3.18 points for GMH at Days 21 and 61, respectively (all p<0.001). Conclusion: The integrated program was associated with greater improvements in patient-reported global physical and mental health than lifestyle modification, with differences persisting at two-month follow-up. This was a secondary analysis of a multicomponent intervention, and the available inferential models used raw PROMIS summary scores.