Treatment of reflux disease using targeted physiotherapy
- Conditions
- Gastroesophageal reflux disease with refractory symptoms despite proton pump inhibitor therapy or an inability to discontinue medical treatment due to early recurrence of symptomsDigestive System
- Registration Number
- ISRCTN66696088
- Lead Sponsor
- Charles University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
1. Patients with GERD with persistent symptoms despite lifestyle modification and maintenance therapy with proton pump inhibitors, or patients who cannot discontinue antireflux medication due to early recurrence of their symptoms.
GERD is diagnosed by positive EGDS and/or positive 24-hour esophageal pH monitoring with impedance and symptoms of GERD are present for at least 6 months prior to diagnosis.
1.1. Positive EGDS = evidence of reflux esophagitis according to the Los Angeles classification
1.2. Positive 24-hour esophageal pH monitoring with impedance = AET > 6% and/or number of reflux episodes >80/24 h performed without antireflux medication (off proton pump inhibitor [PPI] 14 days prior to testing)
2. Patients with GERD who are interested in incorporating diaphragmatic breathing training into their treatment
3. PPI dosing on a long-term on-demand basis or regular basis, in either a standard dose (once daily) or full dose (twice daily).
4. Age 18 years and above
5. Signed informed consent
1. Severe reflux esophagitis, i.e. reflux esophagitis LA C and D, esophageal stenosis undergoing dilatation therapy, esophageal varices
2. Other primary esophageal diseases such as achalasia, esophageal tumors
3. Behavioural oesophageal disorders such as rumination and supragastric belching
4. Large hiatal hernia, i.e. manometric EGJ type III with LES-CD separation =3 cm
5. Severe comorbidities (diabetes mellitus with organ complications, advanced organ failure, i.e. chronic heart failure, severe COPD, severe renal or hepatic dysfunction, scleroderma or other connective tissue disease, mental disorders, neuropathy)
6. Other GIT disorders requiring regular antisecretory medication that do not allow discontinuation (e.g., Barrett's esophagus, gastroduodenal ulcer disease)
7. Pregnancy, lactation
8. Morbid obesity with BMI above 35 kg/m²
9. Severe musculoskeletal conditions or disorders not allowing training and practice of diaphragmatic breathing (e.g. conditions following spinal surgery)
10. Inability to undergo EGDS, HRM and 24-hour esophageal pH monitoring with impedance (e.g. conditions following nasal surgery with inability to insert transnasal probes)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reflux symptoms and quality of life in GERD patients after 3 months of diaphragmatic breathing training are measured using a Gastroesophageal Reflux Disease Questionnaire (GerdQ) and GERD – Health Related Quality of Life (GERD-HRQL) questionnaire. The questionnaires are assessed at baseline, 3, 6, 9, 12 and 15 months
- Secondary Outcome Measures
Name Time Method