The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial

BACKGROUND: The aim of the proposed study is to analyze the effect of a six-week osteopathic visceral manipulation (OVM) program on the flexion-relaxation phenomenon in individuals with non-specific chronic low back pain (LBP) and functional constipation. METHODS/DESIGN: An assessor-blinded, two-arm, randomized, placebo-controlled trial will be conducted. The sample will comprise 76 individuals with non-specific chronic LBP who have functional intestinal constipation, aged 18–65 years. The participants will be randomly allocated to two groups: (1) OVM and (2) sham OVM (SOVM). Evaluations will involve an interview, the Oswestry Disability Index, Fear-Avoidance Beliefs Questionnaire, functional constipation according to Rome III criteria, Biering-Sorensen test to normalize electromyographic (EMG) data, T12–L1 paraspinal level of the EMG signal during the flexion-relaxation phenomenon, 11-point numeric pain rating scale and fingertip-to-floor test. OVM and SOVM will be performed once per week for six weeks. Group 1 will receive OVM for 15 min and Group 2 will receive a sham visceral technique. Evaluations will be performed before and after the first session, after six weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05). The limitation of the study is that the therapist will not be blinded. DISCUSSION: This will be the first trial to analyze the clinical response and electromyographic signals during the flexion-relaxation phenomenon after OVM. TRIAL REGISTRATION: Brazilian Clinical Trial Registry, RBR-7sx8j3. Registered on 26 October 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2532-8) contains supplementary material, which is available to authorized users.