Treament of Rumination
- Conditions
- Rumination Disorders
- Interventions
- Behavioral: BiofeedbackDietary Supplement: Placebo
- Registration Number
- NCT04167371
- Brief Summary
Background. 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 we showed that rumination is produced by an unperceived, somatic response to food ingestion. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of rumination. However, the technique is technically complex and unpractical.
Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of rumination. Selection criteria. Rumination after meal ingestion. Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed after ingestion of a probe meal during the first 3 weeks of the 4 weeks intervention period.
Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Primary Outcome Measure:
Number of rumination events measured by electromyography in response to the challenge meal before and after treatment.
Secondary Outcome Measures:
* Number of self perceived rumination events measured by questionnaires administered daily for 10 days will before and after treatment.
* Associated abdominal symptom measured by questionnaires administered daily for 10 days before and after treatment.
* Follow up: number of self perceived rumination events measured at 1, 3 and 6 months after treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Rumination syndrome
- Relevant organic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biofeedback Biofeedback - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of rumination events after a challenge meal measured by electromyography 4 weeks Rumination events will be identified by recording the activity of the thoraco abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) by electromyography after a challenge meal. The response to the meal will be measured before and after treatment.
- Secondary Outcome Measures
Name Time Method Abdominal discomfort. 4 weeks Abdominal discomfort will be measured by scales graded from 0 (no discomfort) to 10 (severe discomfort) administered daily for 10 days before and after treatment.
Number of self perceived rumination events. 4 weeks Number of rumination events measured by questionnaires administered daily for 10 days before and after treatment.
Number of self perceived rumination events up to 6 months. up to 6 months Number of self perceived rumination events measured daily for 10 days using questionnaires at 1 month, 3 months and 6 months after treatment.
Trial Locations
- Locations (1)
Vall d'Hebron Research Institute
🇪🇸Barcelona, Spain