Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

NCT ID: NCT02214472

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Rumination Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biofeedback

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.

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: BEHAVIORAL

Placebo medication

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Biofeedback

Intervention Type: BEHAVIORAL

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Rumination syndrome

Exclusion Criteria

• Relevant organic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Azpiroz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitary vall d'Hebron

Locations

Fernando Azpiroz

Barcelona, Barcelona, Spain

University Hospital Vall d'Hebron

Barcelona, Catalonia, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 24768808 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27185077 (View on PubMed)

Other Identifiers

PR(AG)200/2011

Identifier Type: -

Identifier Source: org_study_id