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.
研究组 & 干预措施
The experimental group is defined by the sham osteopathic treatment (SOT)
Patients will receive 3 SOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the SOT. The positions of the patient and the practitioner will be the same as in the AOT group
干预措施: the sham osteopathic treatment (Other)
The experimental group is defined by the active osteopathic treatment (AOT)
Patients will receive 3 AOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the AOT.
干预措施: the active osteopathic treatment (AOT) (Other)
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)