OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 404
- 主要终点
- The effectiveness (response to treatment) at 1-month follow-up:
研究概览
简要总结
Osteopathy is chosen by patients as a treatment for IBS but the evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.
详细描述
a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group: active osteopathic treatment. Control group: sham osteopathic treatment. Randomization: allocation ratio 1:1. Assessment times: inclusion and baseline assessment (Day-1; Initial visit V0), Day 8, Day 15 and follow-up (1 month and 3 months), treatments (Day 0, Day 8, Day 15). Primary endpoint: Effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint: Effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size: 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 ans
- •IBS patients (defined according to the Rome IV Criteria)
- •Moderate symptom severity score on the IBS Symptom Severity Scale (IBS-SSS) (values ranging from 175 to 300).
- •Negative colonoscopy within the last 5 years.
- •Psychologically fit to provide signed informed consent.
- •Agreed to undergo the procedures associated with the study
- •Medical insurance
排除标准
- •Have not received any osteopathic treatment in the last 12 months
- •Chronic inflammatory bowel disease or digestive cancer (even if the disease is in remission)
- •Pregnancy
- •Planned or expected elective surgery during the study
- •Dietary and lifestyle changes in the previous month.
- •Use of prohibited concomitant medications in the previous month.
- •Inability to understand or cooperate during the study.
- •No current participation in a biomedical research trial.
结局指标
主要结局
The effectiveness (response to treatment) at 1-month follow-up:
时间窗: 1 month
It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.
次要结局
- Effectiveness at 3 months (response to treatment based on the IBS-SSS) and changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 months.(3 months)