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 presenting in primary care with functional constipation…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is treatment success at 8 months follow-up. Treatment
success is defined as the absence of constipation according to the ROME III
criteria without the use of laxatives in the past 4 weeks
Secondary outcome
Secondary outcome measures are treatment success at 4 months, the absence of
constipation according to the ROME III criteria in the past 4 weeks
irrespective of the use of laxatives at 4 and 8 months, deviant voiding
behaviour, quality of life, costs.
Background summary
Constipation is the most common gastro-intestinal disorder in childhood. In a
survey among Dutch children constipation was in the top 20 most frequently
experienced complaints in the previous 14 days. The incidence of constipation
in general practice is 9.1 per 1000 registered children. Around 3% of children
referred to the general paediatrics* wards has constipation and this increases
up to 25% of children referred to a paediatric gastroenterologist. Education,
dietary advice, toilet training and laxative treatment (conventional therapy)
is currently recommended as the first choice therapy for children with
functional constiaption in primary care. However 3 *-5 years after the start of
medication treatment 52% -64% of the treated children still have constipation.
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. Therefore in this study the effect of
paediatric pelvic physiotherapy in addition to the conventional therapy will be
compared to conventional therapy alone for the treatment of functional
constipation in children in primary care.
Study 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 presenting in primary care with functional
constipation in comparison to conventional treatment alone.
Study design
Randomised controlled trial
Intervention
The therapy (paediatric pelvic physiotherapy) will consist of education, toilet
training, breathing exercises, training of the pelvic floor muscles, training
of the abdominal muscles and abdominal massage. This will be added to the
standard advice and laxatives (conventional treatment) for the treatment of
functional constipation.
Study burden and risks
The total follow-up will be 8 months. Children who participate in the study are
asked to fill in a questionnaire at baseline, at 4 and 8 months follow-up.
Because this study compares two non-experimental and non-invasive treatment
options for childhood functional constipation it won*t impose an risk on
participating children. Furthermore for this study children only have to fill
in questionnaires which doesn't impose an extra risk on the participating
children.
If paediatric pelvic physiotherapy in addition to the conventional treatment is
successful for childhood functional constipation it can lead to less medication
use, an improved quality of life, less productivity losses of parents and less
referrals to the paediatrician.
Because the criteria for childhood constipation and the aetiology of childhood
constipation, like the approach of parents and the toilet trainedness, are
different from the aetiology of adulthood constipation, children will be
included in this study. Furthermore the treatment given by the paediatric
pelvic physiotherapist differ from the treatment given by a pelvic
physiotherapist.
Antonius Deusinglaan 1
Groningen 9700AD
NL
Antonius Deusinglaan 1
Groningen 9700AD
NL
Listed location countries
Age
Inclusion criteria
- Children aged 4 to 17 years
- Diagnosis of functional constipation by GP or paediatrician
- Informed consent of both parents and the child (if aged >= 12 years)
Exclusion criteria
- Physiotherapy or urotherapy for constipation in the past 3 years
- Psycho pathology disabling protocol adherence
- Severe/terminal illness
- Previous enrolment in the trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT=3878 |
CCMO | NL45352.042.13 |