McClurg Doreen, Goodman Kirsteen, Hagen Suzanne, Harris Fional, Treweek Sean, Emmanuel Anton, Norton Christine, Coggrave Maureen, Doran Selina, Norrie John, Donnan Peter, Mason Helen, Manoukian Sarkis
NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA, UK.
NMAHP RU, Stirling University, Stirling, UK.
Trials. 2017 Mar 29;18(1):150. doi: 10.1186/s13063-017-1890-y.
Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50-80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain.
METHODS/DESIGN: This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles.
This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS.
ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.
多发性硬化症（MS）是一种主要影响年轻人的终身疾病。50%至80%的此类患者会出现神经源性肠道功能障碍（NBD），该术语用于描述便秘和大便失禁，这两种情况常同时存在。一项试点研究的数据表明，腹部按摩缓解便秘具有可行性，但其有效性仍不确定。
方法/设计：这是一项多中心患者随机优势试验，将每天进行一次腹部按摩，持续6周的试验策略与不进行按摩的对照策略进行比较，对象为自述便秘困扰的MS患者。主要结局是24周时的神经源性肠道功能障碍评分。两组都将接受优化建议以及MS协会关于MS肠道管理的手册，并将继续接受常规护理。参与者及其临床医生不会对分配的干预措施设盲。结局测量主要是自我报告且匿名提交。管理和分析试验数据的中心试验人员将不知道参与者的分配情况。分析将遵循意向性分析原则。
这项实用的随机对照试验将证明腹部按摩是否是治疗MS患者NBD的一种有效、具有成本效益且可行的辅助治疗方法。
ClinicalTrials.gov，ISRCTN85007023。于2014年6月10日注册。
