PURPOSE: To assess response to osteopathic manual treatment (OMT) according to baseline severity of chronic low back pain (LBP). METHODS: The OSTEOPATHIC trial used a randomized, double-blind, sham-controlled, 2x2 factorial design to study OMT for chronic LBP. A total of 269 (59%) patients reported low baseline pain severity (LBPS) (< 50mm/100mm), whereas 186 (41%) patients reported high baseline pain severity (HBPS) (=> 50mm/100mm). Six OMT sessions were provided over eight weeks and outcomes were assessed at week 12. The primary outcome was substantial LBP improvement (=> 50% pain reduction). The Roland-Morris Disability Questionnaire (RMDQ) and eight other secondary outcomes were also studied. Response ratios (RRs) and 95% confidence intervals (CIs) were used in conjunction with Cochrane Back Review Group criteria to determine OMT effects. RESULTS: There was a large effect size for OMT in providing substantial LBP improvement in patients with HBPS (RR 2.04; 95% CI 1.36 to 3.05; p < 0.001). This was accompanied by clinically important improvement in back-specific functioning on the RMDQ (RR 1.80; 95% CI 1.08 to 3.01; p = 0.02). Both RRs were significantly greater than those observed in patients with LBPS. Osteopathic manual treatment was consistently associated with benefits in all other secondary outcomes in patients with HBPS, although the statistical significance and clinical relevance of results varied. CONCLUSIONS: The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

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