Pediatric pelvic physiotherapy added to conventional treatment of functional constipation in children in primary care/Behandeling van Obstipatie bij Kinderen

Rationale: Education, dietary advice, toilet training and laxative treatment is currently recommended as the first choice therapy for children with functional constipation in primary care (conventional treatment). Paediatric pelvic physiotherapists claim to obtain good results with their treatment and they already treat many children with functional constipation. However because a lack of randomised controlled trials, paediatric pelvic physiotherapy is not yet evidence-based. Objective: The primary objective is to study the effect of paediatric pelvic physiotherapy in addition to conventional therapy on the number of patients with treatment success in children aged 4-17 years in primary care with functional constipation in comparison to conventional treatment alone. Study design: Randomised controlled trial with a follow-up of 8 months. Study population: Children aged 4-17 years with functional constipation in primary care. Intervention: The therapy will consist of education about defecation, toilet training, breathing exercises, training of the pelvic floor muscles, and training of the abdominal muscles. This will be added to the conventional treatment of functional constipation. Main study parameters/endpoints: Primary outcome measure is treatment success at 8 months follow-up. Treatment success is defined as the absence of constipation according the ROME III criteria for functional constipation; without using laxative treatment in the past 4 weeks. Secondary outcome measures are treatment success at 4 months, absence of constipation irrespective of laxative use at 4 and 8 months, quality of life and costs. Study objective: We expect paediatric pelvic physiotherapy in addition to conventional treatment to be more (cost)- effective than conventional treatment alone, after 8 months follow-up. Study design: Follow up visits will be at 4 and 8 months. Intervention: Paediatric pelvic physiotherapy will be given by a certified paediatric physiotherapist with additional education in pelvic physiotherapy, according to the standards of the Dutch Pelvic Physiotherapists Organization (NVFB). Treatment will start within one week after randomisation. The therapy will consist of assessment of motor development, extensive physiotherapy training, breath control, pelvic floor training, core stability training and abdominal massage. It includes isometric training of the abdominal muscles, defecation stimulating exercises on the toilet, and relaxation and diaphragmatic breathing exercises. The paediatric physiotherapist will decide on treatment frequency and duration (usually 3-6 sessions). We will not use a standard protocol for the physiotherapeutic intervention but chose a more flexible, pragmatic approach in which the participating pediatric physiotherapists tailor their treatment to the need of each child, as would be the case in normal practice. To gain insight in the treatment techniques and treatment duration in our study population pediatric physiotherapists register their treatment and the number of visits for each patient on a structured form.