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Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination

Primary Purpose

Rumination Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Biofeedback
Placebo
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rumination Disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rumination syndrome

Exclusion Criteria:

  • relevant organic disease

Sites / Locations

  • University Hospital Vall d'Hebron
  • Fernando Azpiroz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Biofeedback

Placebo medication

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of regurgitation episodes

Secondary Outcome Measures

Postprandial abdominal symptoms

Full Information

First Posted
March 25, 2015
Last Updated
August 8, 2019
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02402946
Brief Title
Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination
Official Title
Valoración Objetiva y Tratamiento de la rumiación
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo medication
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of regurgitation episodes
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Postprandial abdominal symptoms
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rumination syndrome Exclusion Criteria: relevant organic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Azpiroz, MD
Organizational Affiliation
Hospital Universitary vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Vall d'Hebron
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Fernando Azpiroz
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24768808
Citation
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.
Results Reference
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Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination

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