Effects of osteopathic manipulative treatment associated with pain education and clinical hypnosis in individuals with chronic low back pain: study protocol for a randomized sham-controlled clinical trial.

BACKGROUND: Patients with chronic low back pain (CLBP) suffer with functional, social, and psychological aspects. There is a growing number of studies with multimodal approaches in the management of these patients, combining physical and behavioral therapies such as osteopathic manipulative treatment, associating pain education and clinical hypnosis. The aim of the present study will be to evaluate the effects of osteopathic manipulative treatment (OMT) associated with pain neuroscience education (PNE) and clinical hypnosis (CH) on pain and disability in participants with CLBP compared to PNE, CH, and sham therapy. METHODS: A randomized controlled clinical trial will be conducted in participants aged 20-60 years with CLBP who will be divided into two groups. Group 1 will receive PNE and CH associated with OMT, and G2 will receive PNE, CH, and sham therapy. In both groups, 4 interventions of a maximum of 50 min and with an interval of 7 days will be performed. As primary outcomes, pain (numerical pain scale), pressure pain threshold (pressure algometer), and disability (Oswestry Disability Questionnaire) will be evaluated and, as a secondary outcome, global impression of improvement (Percent of Improvement Scale), central sensitization (Central Sensitization Questionnaire), biopsychosocial aspects (Start Beck Toll Questionnaire), and behavior of the autonomic nervous system (heart rate variability) will be assessed. Participants will be evaluated in the pre-intervention moments, immediately after the end of the protocol and 4 weeks after the procedures. Randomization will be created through a simple randomized sequence and the evaluator will be blinded to the allocation of intervention groups. DISCUSSION: The guidelines have been encouraging multimodal, biopsychosocial approaches for patients with CLBP; in this sense, the results of this study can help clinicians and researchers in the implementation of a model of treatment strategy for these patients. In addition, patients may benefit from approaches with minimal risk of deleterious effects and low cost. In addition, it will enable the addition of relevant elements to the literature, with approaches that interact and do not segment the body and brain of patients with CLBP, allowing new studies in this scenario. TRIALS REGISTRATION: Date: September 4, 2021/Number: NCT05042115 .