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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

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 - Pelvis physiotherapy in children with functional constipation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39172
Enrollment
367
Registered
2010-04-26
Start date
2010-12-21
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blocked constipation

Interventions

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 consis

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: * There is functional constipation according to the Rome III criteria. * The children are being treated for this complaint by a pediatrician or (children)- gastroenterologist * The children are referred by a pediatrician or (child)- gastroenterologist * The child (at least 5 years and up to 17 years) at baseline measurement. * The parents sign an informed consent. ** Children 12 years and older sign an informed consent

Exclusion criteria

Exclusion criteria: * Severe motor retardation, making it impossible to independently go to the toilet and / or the clothes off and / or sit without help. * Endocrine and metabolic disorders, such as hypothyroidism, diabetes mellitus and diabetes insipidus. * Neurological and psychiatric disorders such as autism and PDD-NOS. spina bifida, cerebral palsy, anorexia nervosa. * Psychiatric disorders such as autism and PDD-NOS. * SDQ at baseline is above 14 * Down syndrome * M. Hirschsprung

Design outcomes

Primary

MeasureTime frame
The primary outcome measure in this study: The Rome III criteria for functional obstipatie in conjunction with the use of macrogol 3350 or 4000.

Secondary

MeasureTime frame
Secondary outcome measurements in this study: The results of the measuring instruments which, in different ways, measure quality of life and the perceived impact of treatment

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)