Limits...
The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

van Engelenburg-van Lonkhuyzen ML, Bols EM, Benninga MA, Verwijs WA, Bluijssen NM, de Bie RA - BMC Pediatr (2013)

Bottom Line: Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives.Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect).It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands. m.vanengelenburg@maastrichtuniversity.nl

ABSTRACT

Background: Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking.

Methods/design: A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria.

Discussion: This section discusses the relevance of publishing the study design and the development of the presented physiotherapy protocol. It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications. To our knowledge, this article is the first to describe the design of a randomised controlled trial among children with constipation to assess the effect of pelvic physiotherapy as an add-on to standard medical care.

Trial registration: Current Controlled Trials NL30551.068.09.

Show MeSH

Related in: MedlinePlus

Standard medical care in accordance with the ‘Dutch guideline on constipated children’.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC3750818&req=5

Figure 2: Standard medical care in accordance with the ‘Dutch guideline on constipated children’.

Mentions: A child’s participation to the study starts and ends with a visit to a paediatrician. In our multicentre randomised controlled trial, the control group will receive only standard medical care (SMC) (Figure 1) whereas the experimental group will have SMC supplemented with PPT (Figure 2). The control group will have at least three contacts with the paediatrician in five months while the experimental group will have a maximum of six contacts with the physiotherapist. The study duration will be six months from randomisation, with a three-year recruitment period.


The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

van Engelenburg-van Lonkhuyzen ML, Bols EM, Benninga MA, Verwijs WA, Bluijssen NM, de Bie RA - BMC Pediatr (2013)

Standard medical care in accordance with the ‘Dutch guideline on constipated children’.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750818&req=5

Figure 2: Standard medical care in accordance with the ‘Dutch guideline on constipated children’.
Mentions: A child’s participation to the study starts and ends with a visit to a paediatrician. In our multicentre randomised controlled trial, the control group will receive only standard medical care (SMC) (Figure 1) whereas the experimental group will have SMC supplemented with PPT (Figure 2). The control group will have at least three contacts with the paediatrician in five months while the experimental group will have a maximum of six contacts with the physiotherapist. The study duration will be six months from randomisation, with a three-year recruitment period.

Bottom Line: Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives.Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect).It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands. m.vanengelenburg@maastrichtuniversity.nl

ABSTRACT

Background: Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking.

Methods/design: A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria.

Discussion: This section discusses the relevance of publishing the study design and the development of the presented physiotherapy protocol. It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications. To our knowledge, this article is the first to describe the design of a randomised controlled trial among children with constipation to assess the effect of pelvic physiotherapy as an add-on to standard medical care.

Trial registration: Current Controlled Trials NL30551.068.09.

Show MeSH
Related in: MedlinePlus