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Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Primary Purpose

Rumination Disorders

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Biofeedback

Placebo

About this trial

This is an interventional treatment trial for Rumination Disorders focused on measuring Rumination síndrome, Regurgitation, Vomiting, Biofeedback, Electromyography, Abdominal accommodation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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 in front of the patients; in the biofeedback group, patients will be instructed to control muscle activity.

Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.

Outcomes

Primary Outcome Measures

Number of regurgitation episodes

Secondary Outcome Measures

Postprandial abdominal symptoms

Full Information

NCT ID

NCT02214472

First Posted

August 6, 2014

Last Updated

November 9, 2015

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02214472

Brief Title

Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Official Title

Valoración Objetiva y Tratamiento de la rumiación.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

April 2015 (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

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Rumination Disorders

Keywords

Rumination síndrome, Regurgitation, Vomiting, Biofeedback, Electromyography, Abdominal accommodation

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

Arm Title

Placebo medication

Arm Type

Placebo Comparator

Arm Description

Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.

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

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

result

PubMed Identifier

27185077

Citation

Barba E, Accarino A, Soldevilla A, Malagelada JR, Azpiroz F. Randomized, Placebo-Controlled Trial of Biofeedback for the Treatment of Rumination. Am J Gastroenterol. 2016 Jul;111(7):1007-13. doi: 10.1038/ajg.2016.197. Epub 2016 May 17.

Results Reference

derived

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Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

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