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

Not Applicable

Completed

• Conditions: Rumination Disorders
• Interventions: Drug: Placebo; Behavioral: Biofeedback

• Registration Number: NCT02402946
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-30
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Rumination syndrome

Exclusion Criteria

• relevant organic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo medication	Placebo	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.
Biofeedback	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

Primary Outcome Measures

Name	Time	Method
Number of regurgitation episodes	28 days

Secondary Outcome Measures

Name	Time	Method
Postprandial abdominal symptoms	28 days

Trial Locations

Locations (2)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Catalunya, Spain

Fernando Azpiroz; 🇪🇸 Barcelona, Spain