Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial.

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) (18-60y) 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.