Do the symptoms of chronic constipation improve with a Primary Care programme based on behavioural re-education and abdominal massage? Protocol of a randomised clinical trial (Preprint)

BACKGROUND Background: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. OBJECTIVE The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term. METHODS Randomised clinical trial. Participants: people with constipation in the region of Central Catalonia. There will be 3 groups: the control group (CG), behavioural intervention group (BIG) and behavioural intervention and massage group (BIMG). Constipation will be assessed with the Bristol scale, Rome IV Criteria and the number of laxatives; and quality of life with the CVE-20 Questionnaire. RESULTS Enrollment concluded in April 2024, with data collection set to finish by February 2026. The findings will be presented at national and international conferences and published in peer-reviewed journals. CONCLUSIONS Research is needed on conservative, non-pharmacological treatment to try to reduce one of the main conditions affecting public health, and thus reduce the possible illnesses associated with constipation and reduce costs to the health system. CLINICALTRIAL Registry - Clinical Trials, trial registration number - NCT06359249, 05/04/2024.