- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02402946
Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination
August 8, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute
Valoración Objetiva y Tratamiento de la rumiación
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08035
- Fernando Azpiroz
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Catalunya
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Barcelona, Catalunya, Spain, 08035
- University Hospital Vall D'Hebron
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Rumination syndrome
Exclusion Criteria:
- relevant organic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biofeedback
Abdomino-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
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Placebo Comparator: Placebo medication
Electromyography will be recorded but not shown to the patients.
Patienst will take a pill of placebo and receive no instructions about controlling muscular activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of regurgitation episodes
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postprandial abdominal symptoms
Time Frame: 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fernando Azpiroz, MD, Hospital Universitary vall d'Hebron
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 25, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 30, 2015
Study Record Updates
Last Update Posted (Actual)
August 9, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AG)200/2011 ammendment
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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