Geneva Switzerland, 9 may – 12 may 2018

Physiotherapy for children with functional constipation: a pragmatic randomized controlled trial in primary care

JJGT van Summeren1, GA Holtman1, BJ Kollen1, Y Lisman-van Leeuwen1, AHC van Ulsen-Rust2, MM Tabbers3, JH Dekker1, MY Berger1

Affiliations: 1University of Groningen, University Medical Center Groningen, the Netherlands, 2 Pelvicum kinderbekkenfysiotherapie Groningen, the Netherlands, 3 Emma Children’s Hospital/Amsterdam UMC, Location AMC, Amsterdam, the Netherlands

Abstract

Background Children with functional constipation (FC) may experience long-term symptoms despite treatment. The pathophysiology underlying FC is poorly understood, but it is thought that many children have dyssynergic defecation. Physiotherapy has shown promising results in hospitals, however, benefits of physiotherapy were considered optimal for children with FC of short duration. Therefore, we aimed to determine the effectiveness of physiotherapy plus CT compared to CT alone over 8-month follow-up period for the treatment of FC in children aged 4–17 years in primary care in the Netherlands.

Methods This was an 8-month pragmatic randomized controlled trial in primary care of children with FC aged 4–17 years. CT comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of FC (Rome III criteria) without laxative use. Secondary outcomes included the absence of FC irrespective of continue laxative use and the global perceived treatment effect. Researchers were blinded to group allocation during assignment and data analyses, but participants were not. The sample size was estimated at 128 children (10% loss to follow-up, alpha 0.05, power 0.80) based on an expected treatment success of 50% in the control group after 8 months, with physiotherapy hypothesized to improve success by an additional 25%. Results of longitudinal analyses in the intention-to-treat population are reported as adjusted relative risks (aRR) and 95% confidence intervals (95%CI).

Results Children were allocated to CT plus physiotherapy or CT alone (67 per group). The treatment success percentage was not statistically improved by adding physiotherapy to CT (aRR 0.80, 95%CI 0.44–1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving CT alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without FC, irrespective of continued laxative use, was not statistically different between groups (aRR 1.12, 95%CI 0.82–1.34). After 4 and 8 months, the percentage of children without FC was respectively 68% and 83% in the physiotherapy group, and 64% and 61% in the CT group. Notably, parents reported significantly more global symptom improvement after physiotherapy than after CT (aRR 1.40; 95%CI 1.00–1.73).

Discussion We find no evidence to recommend physiotherapy for all children with FC in primary care. More research is needed to evaluate whether physiotherapy in primary care is effective for children with symptoms of longer duration.

 

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