Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Patient rating of improvement in symptoms
研究概览
简要总结
The primary aim of the project is to investigate whether a behavioural training programme improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to have, despite their disease being controlled by medication. The other aim is to determine if there are factors which influence how well the training programme works.
People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6 sessions with a pelvic floor trained physiotherapist over a period of 6 months with further follow up at 12 months..
详细描述
Inflammatory bowel diseases, chiefly Crohn's disease and ulcerative colitis, are chronic gastrointestinal (gut) conditions which tend to flare up some times and be quiet for other periods of time. They are usually controlled by medication. Inflammatory bowel disease is becoming more common, is usually diagnosed at a young age and is lifelong.
A significant number of people with inflammatory bowel disease can have bowel symptoms which are bothersome even when the disease is quiescent. These symptoms include bowel urgency, frequent toileting, incontinence (leakage), constipation (infrequent bowel actions and/or difficulty emptying the bowel), abdominal pain, rectal pain or abdominal bloating. The symptoms can be very embarrassing or stressful, limiting activities and making life less enjoyable.
People with these bowel symptoms, but without inflammatory bowel disease, respond to a type of therapy called behavioural treatment. We don't know yet if this treatment helps people with inflammatory bowel disease.
Behavioural treatment involves learning about how the bowel works, better ways to manage bowel problems and specific exercises to improve bowel control. Specially trained pelvic floor physiotherapists provide 2-6 sessions, over 6 months, of behavioural treatment which may include the use of biofeedback techniques.
Participants will be asked to complete surveys at the beginning and end of treatment and 12 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All assessments are conducted by an assessor not providing the intervention
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven history of inflammatory bowel disease
- •Clinical evidence of mild, stable disease or remission
- •Mayo score ≤ 4, Harvey Bradshaw index ≤ 7
- •Bothersome lower bowel symptoms of any of the following: frequency, urgency, incontinence, difficult evacuation, constipation
排除标准
- •Significant medical or psychiatric comorbidity that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
- •Clinically significant narcotic or substance abuse that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
- •Recognised eating disorder
- •Non- English speaking or illiterate
- •Pregnancy
- •Previous pelvic floor physiotherapy
- •Current participant in another trial
结局指标
主要结局
Patient rating of improvement in symptoms
时间窗: At study completion, up to 12 weeks
Proportion of patients achieving a rating of 'moderately improved' or 'substantially improved' on a 7 point Likert scale ranging from 'substantially worse' to 'substantially improved'
次要结局
- Change in Hospital Anxiety and Depression Score (HADS)(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Brief Cope score(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in St Marks Faecal Incontinence Score(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Personal assessment of Constipation Symptoms (PAC-SYM) score(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Inflammatory Bowel disease questionnaire (IBDQ) score(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Brief Illness Perception Questionnaire score(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Short Form -36 (SF-36) score(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Euro-Qol (EQ-5D)(From baseline to study completion (up to 12 weeks) and at 1 year)
- Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES)(From baseline to study completion (up to 12 weeks) and at 1 year)
研究者
Angela Khera
Principal Investigator
St Vincent's Hospital Melbourne