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临床试验/NCT06150638
NCT06150638已完成不适用

Tratamiento de la distensión Abdominal Funcional Mediante Biofeedback no Instrumental

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2024年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Sensation of 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 based on electromyography-guided control of abdominothoracic muscular activity. 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 non-instrumental biofeedback technique for the treatment of abdominal distension.

Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal.

Intervention. Patients will be randomized into biofeedback in 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. 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
  • patients are able to identify the offending foodstuff

排除标准

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

结局指标

主要结局

Sensation of abdominal distension

时间窗: 4 weeks

Sensation 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

  • Changes in girth produced by the probe meal(4 weeks)
  • Effect of probe meal on sensation of abdominal distension(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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