title: The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials NL30551.068.09.
authors.affiliation: Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands. m.vanengelenburg@maastrichtuniversity.nl
authors.forename: Marieke L
authors.initials: ML
authors.lastname: van Engelenburg-van Lonkhuyzen
authors.forename: Esther M J
authors.initials: EM
authors.lastname: Bols
authors.forename: Marc A
authors.initials: MA
authors.lastname: Benninga
authors.forename: Wim A
authors.initials: WA
authors.lastname: Verwijs
authors.forename: Netty M W L
authors.initials: NM
authors.lastname: Bluijssen
authors.forename: Rob A
authors.initials: RA
authors.lastname: de Bie
mesh_terms: D000293:Adolescent; D001676:Biofeedback, Psychology; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003248:Constipation / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D053580:Muscle Strength; D017773:Pelvic Floor / Q000503:physiopathology; D026741:Physical Therapy Modalities; D012107:Research Design; D016896:Treatment Outcome
references.citation: J Gastroenterol Hepatol. 2009 Dec;24(12):1876-84
references.pmid: 19686406
references.citation: J Pediatr (Rio J). 2006 Nov-Dec;82(6):403-5
references.pmid: 17171199
references.citation: Acta Paediatr. 2004 Mar;93(3):386-9
references.pmid: 15124844
references.citation: Arch Dis Child. 1998 Aug;79(2):131-5
references.pmid: 9797593
references.citation: J Urol. 2005 Oct;174(4 Pt 2):1623-7; discussion 1627-8
references.pmid: 16148668
references.citation: J Pediatr Urol. 2011 Jun;7(3):342-8
references.pmid: 21527216
references.citation: Pediatrics. 2006 May;117(5):1575-84
references.pmid: 16651311
references.citation: Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8
references.pmid: 11494188
references.citation: Man Ther. 2004 Feb;9(1):3-12
references.pmid: 14723856
references.citation: J Pediatr. 2011 Jan;158(1):119-23, 123.e1-4
references.pmid: 20850761
references.citation: Neurourol Urodyn. 2005;24(4):374-80
references.pmid: 15977259
references.citation: Pediatrics. 2001 Jul;108(1):E9
references.pmid: 11433088
references.citation: Neurourol Urodyn. 2007;26(3):362-71
references.pmid: 17304528
references.citation: Eur J Pediatr. 2011 Aug;170(8):955-63
references.pmid: 21701812
references.citation: J Pediatr Gastroenterol Nutr. 2011 Dec;53 Suppl 2:S55-6
references.pmid: 22470932
references.citation: Surg Innov. 2007 Dec;14(4):270-4
references.pmid: 18178915
references.citation: Res Dev Disabil. 2011 Jul-Aug;32(4):1361-9
references.pmid: 21330102
references.citation: J Pediatr Gastroenterol Nutr. 2002 Apr;34(4):378-84
references.pmid: 11930093
references.citation: J Pediatr Gastroenterol Nutr. 2008 Nov;47(5):607-11
references.pmid: 18979583
references.citation: Semin Pediatr Surg. 1995 Feb;4(1):48-53
references.pmid: 7728508
references.citation: Eur Child Adolesc Psychiatry. 2003 Jan;12(1):1-8
references.pmid: 12601558
references.citation: Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:99-105
references.pmid: 19132309
references.citation: Am J Gastroenterol. 2006 Oct;101(10):2401-9
references.pmid: 17032205
references.citation: Nat Clin Pract Gastroenterol Hepatol. 2008 Jul;5(7):371-82
references.pmid: 18521115
references.citation: J Pediatr Urol. 2007 Apr;3(2):163
references.pmid: 18947726
references.citation: J Trop Pediatr. 2012 Aug;58(4):280-5
references.pmid: 22147280
references.citation: Neurogastroenterol Motil. 2009 Dec;21 Suppl 2:55-61
references.pmid: 19824938
references.citation: J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41
references.pmid: 17013448
references.citation: World J Gastroenterol. 2006 Nov 28;12(44):7069-74
references.pmid: 17131466
references.citation: Pediatrics. 2008 May;121(5):e1334-41
references.pmid: 18450876
references.citation: Arch Phys Med Rehabil. 2008 Sep;89(9):1741-7
references.pmid: 18760158
references.citation: Paediatr Drugs. 2007;9(1):33-46
references.pmid: 17291135
references.citation: Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):29-41
references.pmid: 21382577
references.citation: Dis Colon Rectum. 2009 Oct;52(10):1730-7
references.pmid: 19966605
references.citation: Gastroenterology. 2010 Apr;138(4):1231-5, 1235.e1-4
references.pmid: 20176023
references.citation: Pediatr Clin North Am. 2007 Dec;54(6):927-47; xi
references.pmid: 18061784
references.citation: Lancet. 1996 Sep 21;348(9030):776-80
references.pmid: 8813983
references.citation: Coll Antropol. 2002 Dec;26 Suppl:93-101
references.pmid: 12674840
references.citation: Br J Clin Psychol. 2004 Nov;43(Pt 4):437-48
references.pmid: 15530213
references.citation: J Bodyw Mov Ther. 2010 Jan;14(1):84-98
references.pmid: 20006294
references.citation: Pediatrics. 1995 Jul;96(1 Pt 1):105-10
references.pmid: 7596696
references.citation: Cochrane Database Syst Rev. 2006 Apr 19;(2):CD002240
references.pmid: 16625557
references.citation: J Pediatr Gastroenterol Nutr. 2004 Nov;39(5):448-64
references.pmid: 15572881
references.citation: Am J Gastroenterol. 2004 Aug;99(8):1579-84
references.pmid: 15307880
references.citation: Res Dev Disabil. 2011 Mar-Apr;32(2):674-80
references.pmid: 21146955
references.citation: Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18
references.pmid: 21382575
references.citation: Tech Coloproctol. 2001 Dec;5(3):163-4
references.pmid: 11875684
references.citation: Appl Psychophysiol Biofeedback. 2004 Sep;29(3):153-74
references.pmid: 15497616
references.citation: BJU Int. 2007 Feb;99(2):407-12
references.pmid: 17034497
references.citation: Arch Dis Child. 2009 Feb;94(2):117-31
references.pmid: 18713795
references.citation: Gastroenterology. 2006 Apr;130(5):1377-90
references.pmid: 16678553
references.citation: Patient Educ Couns. 2007 Jul;67(1-2):63-77
references.pmid: 17374472
references.citation: J Urol. 2011 Dec;186(6):2379-84
references.pmid: 22019033
references.citation: Arch Dis Child. 1996 Nov;75(5):367-74
references.pmid: 8957948
references.citation: Nat Rev Gastroenterol Hepatol. 2011 Aug 02;8(9):502-11
references.pmid: 21808283
references.citation: J Rheumatol. 2001 Dec;28(12):2726-30
references.pmid: 11764224