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临床试验/NCT06369753
NCT06369753招募中不适用

Tratamiento de la distensión Abdominal Funcional

Hospital Universitari Vall d'Hebron Research Institute14 个研究点 分布在 7 个国家目标入组 100 人开始时间: 2025年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
14
主要终点
Visible abdominal distension

研究概览

简要总结

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.

Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.

Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • episodes of visible abdominal distension triggered by meal ingestion

排除标准

  • organic cause detected by clinical work-up
  • constipation
  • abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation

结局指标

主要结局

Visible abdominal distension

时间窗: 4 weeks

Distension score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.

次要结局

  • Sensation of abdominal discomfort/pain(4 weeks)
  • Sensation of abdominal pressure/fullness(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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