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临床试验/NCT02402946
NCT02402946已完成不适用

Valoración Objetiva y Tratamiento de la rumiación

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Number of regurgitation episodes

研究概览

简要总结

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestión. After having identified the key mechanisms of rumination, we developed an original EMG guided biofeedback technique with specific targets for correction, based on EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the potential effectivity of this treatment. In a subsequent study this technique was validated by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of a simplified biofeedback technique not requiring EMG-guided control.

详细描述

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will not. In each patient 3 sessions will be performed over a 10-day period. Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events by questionnaries administered daily for 10 days) will be measured before and after treatment.

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

入选标准

  • Rumination syndrome

排除标准

  • relevant organic disease

研究组 & 干预措施

Biofeedback

Experimental

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal will be displayed on a monitor but not showed to the patients; in the biofeedback group, patients will be instructed to control, abdomino-thoracic muscle activity

干预措施: Biofeedback (Behavioral)

Placebo medication

Placebo Comparator

Electromyography will be recorded but not shown to the patients. Patienst will take a pill of placebo and receive no instructions about controlling muscular activity.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of regurgitation episodes

时间窗: 28 days

次要结局

  • Postprandial abdominal symptoms(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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