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

Walkyria Vilas Boas Fernandes, Cleofás Rodríguez Blanco, Fabiano Politti, Fernanda de Cordoba Lanza, Paulo Roberto Garcia Lucareli, João Carlos Ferrari Corrêa, Walkyria Vilas Boas Fernandes, Cleofás Rodríguez Blanco, Fabiano Politti, Fernanda de Cordoba Lanza, Paulo Roberto Garcia Lucareli, João Carlos Ferrari Corrêa

Abstract

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.

Keywords: Constipation; Electromyography; Flexion-relaxation; Low back pain; Visceral manipulation.

Conflict of interest statement

Ethics approval and consent to participate

The proposed study will follow the guidelines for research involving human subjects established by the National Health Board of the Brazilian Health Ministry in October 1996. The study will be conducted at physical therapy clinics in the city of Rondonópolis, state of Mato Grosso, Brazil and received approval from the Human Research Ethics Committee of the Nove de Julho Educational Association (certificate no. 2.348.912/2017). The participants will have access to all information and will be allowed to withdraw from the study at any time with no negative repercussions. The identification of each individual will remain concealed based on the ethical principles of confidentiality and privacy.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for patient participations. ODI Oswestry Index Disability, NPRS Numeric Pain Rating Scale, EMG electromyographic, FABQ Fear-Avoidance Beliefs Questionnaire

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