Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination

Rumination Disorders Clinical Trial

Official title: Valoración Objetiva y Tratamiento de la rumiación

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Feeding and Eating Disorders of Childhood
• Rumination Disorders

• NCT number: NCT02402946
• Study type: Interventional
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Completion date: June 2016