OBJECTIVE: To investigate the effects of an osteopathic manipulative treatment (OMT), which includes a diaphragm intervention compared to the same OMT with a sham diaphragm intervention in chronic nonspecific low back pain (NS-CLBP). DESIGN: Parallel group randomized controlled trial. SETTING: Private and institutional health centers. PARTICIPANTS: Participants (n = 66) (18 to 60y) with a diagnosis of NS-CLBP lasting at least 3 months. INTERVENTIONS: Participants were randomized to receive either an OMT protocol including specific diaphragm techniques (n = 33) or the same OMT protocol with a sham diaphragm intervention (n = 33), conducted in 5 sessions provided during 4 weeks. MAIN OUTCOME MEASURES: The primary outcomes were pain (evaluated with the Short-Form McGill Pain Questionnaire (SF-MPQ) and the visual analog scale (VAS)) and disability (assessed with the Roland-Morris Questionnaire (RMQ) and the Oswestry Disability Index (ODI)). Secondary outcomes were fear-avoidance beliefs, level of anxiety and depression, and pain catastrophization. All outcome measures were evaluated at baseline, at week 4, and at week 12. RESULTS: A statistically significant reduction was observed in the experimental group compared to the sham group in all variables assessed at week 4 and at week 12 (SF-MPQ (mean difference -6.2; 95% confidence interval -8.6 to -3.8); VAS (mean difference -2.7; 95% confidence interval -3.6 to -1.8); RMQ (mean difference -3.8; 95% confidence interval -5.4 to -2.2); ODI (mean difference -10.6; 95% confidence interval -14.9 to 6.3)). Moreover, improvements in pain and disability were clinically relevant. CONCLUSIONS: An OMT protocol that includes diaphragm techniques produces significant and clinically relevant improvements in pain and disability in patients with NS-CLBP compared to the same OMT protocol using sham diaphragm techniques.

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