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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback | Experimental | 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. |
|
| Placebo medication | Placebo Comparator | Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback | Behavioral |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of regurgitation episodes | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial abdominal symptoms | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Azpiroz, MD | Hospital Universitary vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fernando Azpiroz | Barcelona | Barcelona | 08035 | Spain | ||
| University Hospital Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24768808 | Result | 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. | |
| 27185077 |
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| ID | Term |
|---|---|
| D000079562 | Rumination Syndrome |
| D005764 | Gastroesophageal Reflux |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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|
| Barcelona |
| Catalonia |
| 08035 |
| Spain |
| 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. |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |