Department of Epidemiology, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.
BMC Pediatr. 2013 Aug 2;13:112. doi: 10.1186/1471-2431-13-112.
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.
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.
Current Controlled Trials NL30551.068.09.
功能性便秘是一种全球性的常见疾病，可发生于所有儿科年龄段。功能性便秘可能由结肠转运延迟或盆底肌肉功能障碍引起。儿科实践中的标准医疗护理通常基于临床经验，主要包括行为方法和如厕训练，以及泻药处方。缺乏评估盆底物理疗法对这种疾病的疗效的证据。
方法/设计：设计了一项双臂、多中心随机对照试验。我们假设，对于 5 至 17 岁的便秘儿童，盆底物理疗法联合标准医疗护理将比单独接受标准医疗护理更有效。符合罗马 III 标准的功能性便秘儿童将被纳入研究。基于网络的基线和随访测量，分别在纳入后 3 个月和 6 个月进行，包括与问题严重程度相关的数字评分量表、《长处和困难问卷》以及干预后主观改善（整体感知效果）。在基线和随访测量时，将由物理治疗师对盆底肌肉功能进行检查，包括数字测试和生物反馈。对照组仅接受标准医疗护理，在 5 个月内至少进行 3 次接触，而实验组则接受标准医疗护理加盆底物理治疗，最多进行 6 次接触。物理治疗干预将包括标准医疗护理、盆底肌肉训练、呼吸注意、放松和身体及姿势意识。研究时间从随机分组开始，为期 6 个月，招募期为 3 年。主要结局是根据罗马 III 标准无功能性便秘。
这部分讨论了发表研究设计和制定所提出的物理治疗方案的相关性。它还讨论了在解释文献时遇到的困难，包括生物反馈的有效性、潜在混杂因素以及未来的研究方向。据我们所知，这是第一篇描述便秘儿童中盆底物理疗法作为标准医疗护理的附加治疗的随机对照试验设计的文章。
当前对照试验 NL30551.068.09。
