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ID
Source
Brief title
Health condition
child, constipation, physiotherapy, kinderen, obstipatie, fysiotherapie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment success at 8 months follow-up.
Treatment success is defined as the absence of constipation according the QPGS ROME III questionnaire without the use of laxatives.
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, quality of life, costs.
Background summary
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.
Antwoordnummer 253
J.J.G.T. Summeren, van
Groningen 9700 VB
The Netherlands
050-3632888
J.J.G.T.van.Summeren@umcg.nl
Antwoordnummer 253
J.J.G.T. Summeren, van
Groningen 9700 VB
The Netherlands
050-3632888
J.J.G.T.van.Summeren@umcg.nl
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
- Psychopathology disabling protocol adherence
- Severe/terminal ilness
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL4654 |
NTR-old | NTR4797 |
Other | ZonMW : 80-83700-98-41027 |