A multicenter randomized controlled trial of the effectiveness of pelvic physical therapy for children 5-17 years with functional constipation as SURPLUS to paediatric usual care

Constipation in children is common. The prevalence of constipation in children
aged 0-18 years in the Netherlands, depending on the criteria is 0.3% -8%.
Functional constipation can be caused by the dysfunction of the various
systems, colon and rectum, pelvic floor muscles and sphincter complex.
Defecation disorders including constipation, often have a major impact on the
psychosocial functioning of a child and can be stressful for the whole family,
and in particular for the development of the child. Wrongly is assumed that
the signs or symptoms of constipation naturally pass, while recent
longitudinal Dutch study found that about one third remain constipated. In 20%
of the respondents, the quality of life in adulthood is negatively affected by
constipation. In addition constipation in adults appears as a major influence
on damage to the pelvic floor as obstetric trauma, resulting in urinary and
fecal incontinence. To date, there is little scientific evidence for both the
medical and psychological effective treatment of this complaint. No studies
were found on physiotherapists treatment, while in the Netherlands more and
more children are referred to the physiotherapist specialized in these
problems, the pelvic physiotherapist. Scientific studies in paediatric pelvic
physical therapy for the pelvic floor parameters in conjunction with functional
use of the pelvic floor muscles are not done.

The purpose of this study is to investigate the effectiveness of pelvic
physical therapy as a SURPLUS to the paediatric usual care in children (5-17
years) with functional constipation.
Other research questions are:
Does pelvic physiotherapy treatment has an effect on the quality of life of the
child
Is it possible to develop a standard of pelvic floor function in children.

A multicentre RCT is developed in which 367 children (5 to 17 years) with
functional constipation according to Rome III criteria are randomized into two
research groups. In this controlled, pragmatic research the control group
receives only the paediatric usual care and the experimental group the
pediatric usual care supplemented with pelvic physiotherapy. Paediatricians
from seven hospitals and 11 (pelvic) physiotherapists spread over the
Netherlands take part in this study. An electronic patient document (EPD) was
developed. The EPD consists all measuring instruments used in the study,
including questionnaires and urinary and defecation diaries. Doctors and pelvis
physiotherapists can keep up their files in the EPD. The parents and children
can keep up the diaries and the questionnaires at home. Immediately after the
consultation with the pelvic physiotherapist blinded randomization takes place
to control or experimental group for the total cohort in the ratio 1:1.
Blinding of therapist and child in the study is not possible. By using the EPD,
all data provided anonymously what allows blinding the investigator.

The treatment process of a child with constipation in this study starts and
stops at the paeditatrician and takes in total not more then seven months.
The treatment at the paeditatrician will consist the prescription of laxantia,
information about the complaint, eating, drinking and excercising and of toilet
training. For additional urinary complaints the doctor follows his own
treatment policy.
The treatment at the pelvic physiotherapist will consist the use of laxantia,
information about the complaint, eating, drinking, excercising, toilet training
and of locomotor therapy. The locomotor therapy (teaching changes in posture,
muscle tone, muscle coordination and movement, both general and specific to the
abdominal and pelvic floor muscles) shall be supplemented , when needed, with
myofeedback and / or rectal balloon training.

not applicable