Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination
Valoración Objetiva y Tratamiento de la rumiación
1 other identifier
interventional
24
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 9, 2019
November 1, 2016
10 months
March 25, 2015
August 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of regurgitation episodes
28 days
Secondary Outcomes (1)
Postprandial abdominal symptoms
28 days
Study Arms (2)
Biofeedback
EXPERIMENTALAbdomino-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
Placebo medication
PLACEBO COMPARATORElectromyography will be recorded but not shown to the patients. Patienst will take a pill of placebo and receive no instructions about controlling muscular activity.
Interventions
Eligibility Criteria
You may qualify if:
- Rumination syndrome
You may not qualify if:
- relevant organic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Fernando Azpiroz
Barcelona, 08035, Spain
Related Publications (1)
Barba E, Burri E, Accarino A, Malagelada C, Rodriguez-Urrutia A, Soldevilla A, Malagelada JR, Azpiroz F. Biofeedback-guided control of abdominothoracic muscular activity reduces regurgitation episodes in patients with rumination. Clin Gastroenterol Hepatol. 2015 Jan;13(1):100-6.e1. doi: 10.1016/j.cgh.2014.04.018. Epub 2014 Apr 24.
PMID: 24768808BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Azpiroz, MD
Hospital Universitary vall d'Hebron
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
March 30, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
August 9, 2019
Record last verified: 2016-11