Treatment of Rumination by Biofeedback - a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02214472|
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : November 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Rumination Disorders||Behavioral: Biofeedback Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Valoración Objetiva y Tratamiento de la rumiación.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||April 2015|
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.
Placebo Comparator: Placebo medication
Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
- Number of regurgitation episodes [ Time Frame: 28 days ]
- Postprandial abdominal symptoms [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214472
|University Hospital Vall d'Hebron|
|Barcelona, Catalunya, Spain, 08035|
|Barcelona, Spain, 08035|
|Principal Investigator:||Fernando Azpiroz, MD||Hospital Universitary vall d'Hebron|