Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Rumination Disorders
• Interventions: Drug: Placebo; Behavioral: Biofeedback

• Registration Number: NCT02214472
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a previous study the investigators showed that rumination is produced by an unperceived, somatic response to food ingestion.

After having identified the key mechanisms of rumination, the investigators 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 the investigators showed the potential effectivity of this treatment. The current aim is to validate this previous uncontrolled observation by a formal placebo-controlled, randomized trial.

Detailed Description

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal displayed on a monitor and front in the patients: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will receive a pill of placebo. 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 questionnaires administered daily for 10 days) will be measured before and after treatment.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-12
• Primary Completion: 2014-10
• Study Completion: 2015-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Rumination syndrome

Exclusion Criteria

• Relevant organic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo medication	Placebo	Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
Biofeedback	Biofeedback	Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal will be displayed on a monitor in front of the patients; in the biofeedback group, patients will be instructed to control muscle activity.

Primary Outcome Measures

Name	Time	Method
Number of regurgitation episodes	28 days

Secondary Outcome Measures

Name	Time	Method
Postprandial abdominal symptoms	28 days

Trial Locations

Locations (2)

Fernando Azpiroz; 🇪🇸 Barcelona, Spain

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Catalunya, Spain