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

NCT ID: NCT02402946

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-06-30

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.

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 but not showed to the patients; in the biofeedback group, patients will be instructed to control, abdomino-thoracic muscle activity

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: BEHAVIORAL

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.

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: No

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

University Hospital Vall d'Hebron

Barcelona, Catalonia, Spain

Fernando Azpiroz

Barcelona, , 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: BACKGROUND

PMID: 24768808 (View on PubMed)

Other Identifiers

PR(AG)200/2011 ammendment

Identifier Type: -

Identifier Source: org_study_id