(Kosten)-effectiviteit van fysiotherapie toegevoegd aan de standaard behandeling van kinderen met functionele obstipatie

Titel onderzoek

(Kosten)-effectiviteit van fysiotherapie toegevoegd aan de standaard behandeling van kinderen met functionele obstipatie

Titel onderzoek Engels

Physiotherapy added to conventional treatment of functional constipation in children in primary care

Onderzoeksvraag

To determine the (cost)-effectiveness of physiotherapy plus conventional treatment (CT) compared to CT alone for the treatment of functional constipation (FC) in children aged 4–17 years in primary care.

Uitgangsvraag PICO

P

Children diagnosed with functional constipation aged 4 to 18 years

I

Physiotherapy added to conventional treatment

C

Conventional treatment

O

Treatment success over 8 months – defined as the absence of FC (Rome III criteria) without laxative use

Organisatie

Universitair Medisch Centrum Groningen

Afdeling

General practice and elderly care medicine

Samenvatting van het onderzoek

Objectives and study: The aim of this study is to assess the effectiveness and cost-effectiveness of adding physiotherapy to conventional treatment for children with functional constipation in primary care. Physiotherapy is focusing on improving the coordination between the pelvic floor and abdominal musculature during bowel movement, while conventional treatment is mainly focusing on symptomatic relief of symptoms, therefore, we expect the effects of physiotherapy will be more sustainable than the effects of conventional treatment.

Methods: Wedesigned a randomised controlled trial (RCT) of children aged 4–17 years with functional constipation diagnosed by a general practitioner or pediatrician. Children in the intervention group received physiotherapy plus conventional treatment, and those in the control group received conventional treatment only. The primary outcome was treatment success over 8 months, defined as the absence of FC (Rome III criteria) without laxative use. Secondary outcomes included the absence of FC irrespective of continuation of laxative use, quality of life, global perceived treatment effect and costs. The sample size was calculated with expected treatment success rates after 6–12 months of 50% and 75% in the conventional and intervention groups, respectively. Given an expected loss to follow-up of 10%, we estimated a total sample size of 128 children (alpha 0.05, power 0.80).

Clinical impact: The results of this trial will provide valuable information for general practitioners and others involved in the treatment of children with functional constipation, and for stakeholders involved in clinical decision making.

Startdatum onderzoek

Type onderzoek

Therapeutisch

Aard van het onderzoek

Medisch inhoudelijk

Design van het onderzoek

Randomized (controlled) trial

Onderzoeker

Jojanneke van Summeren

Functie betrokkene

Uitvoerend onderzoeker, PhD student

Andere betrokkenen

Marjolein Berger (projectleider)

Janny Dekker (projectgroeplid)

Alice van Ulsen-Rust (projecgroeplid)

Merit Tabbers (projectgroep adviseur)

Boudewijn Kollen (projectgroep adviseur)

Karin Vermeulen (projectgroep adviseur)

Yvonne Lisman- van Leeuwen (projectgroep adviseur)

Contactpersoon

Gea Holtman, projectgroeplid

ICPC codes

D12

Voortgang

Lopend onderzoek

Bekostiging

Tweede geldstroom; via NWO, KNAW of ZonMw

Samenwerking(en) met andere afdelingen of instituten

Andere klinische afdeling, andere organisatie

Soort samenwerking

Uitwisselen van medisch inhoudelijke kennis.