Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Valoración Objetiva y Tratamiento de la rumiación.

Conditions
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Rumination Disorders

Intervention / Treatment
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* Behavioral: Biofeedback
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rumination syndrome Exclusion Criteria: Relevant organic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>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. | Behavioral: Biofeedback<br> <br> |
| Placebo Comparator: Placebo medication<br>Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of regurgitation episodes |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial abdominal symptoms |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rumination síndrome, Regurgitation, Vomiting, Biofeedback, Electromyography, Abdominal accommodation