Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Rumination Disorders

Treatments: Drug: Placebo; Behavioral: Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02214472

PR(AG)200/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Rumination syndrome

Exclusion criteria

• Relevant organic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

Biofeedback

Experimental group

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.

Treatment:

Behavioral: Biofeedback

Placebo medication

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo