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Open Access Study protocol

The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial

Marieke L van Engelenburg – van Lonkhuyzen1*, Esther MJ Bols12, Marc A Benninga3, Wim A Verwijs4, Netty MWL Bluijssen5 and Rob A de Bie12

Author Affiliations

1 Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), PO Box 616, 6200, MD, Maastricht, the Netherlands

2 Centre for Evidence Based Physiotherapy, MUMC+, PO Box 616, 6200, MD, Maastricht, the Netherlands

3 Department of Paediatric Gastroenterology, Emma Children’s Hospital/AMC, Meibergdreef 9, 1105, AZ, Amsterdam, the Netherlands

4 Zuwe Hofpoort Ziekenhuis, Polanerbaan 2, 3447, GN, Woerden, the Netherlands

5 Fysiotherapie De Groote Wielen, Grootewielenlaan 95, 5247, JA, Rosmalen, the Netherlands

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BMC Pediatrics 2013, 13:112  doi:10.1186/1471-2431-13-112

Published: 2 August 2013

Abstract

Background

Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking.

Methods/design

A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria.

Discussion

This section discusses the relevance of publishing the study design and the development of the presented physiotherapy protocol. It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications. To our knowledge, this article is the first to describe the design of a randomised controlled trial among children with constipation to assess the effect of pelvic physiotherapy as an add-on to standard medical care.

Trial registration

Current Controlled Trials NL30551.068.09

Keywords:
Biofeedback; Children; Constipation; Incontinence; Manometry; Pelvic floor; Physiotherapy; Physical therapy; Randomised controlled trial; Study protocol