Gastro-oesophageal Reflux Disease Clinical Trial
Official title:
Osteopathic Manipulative Treatment for Patients Affected by Symptoms Related to Gastro-oesophageal Reflux Disease
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Retrosternal burning sensation and/or regurgitation - Diagnosis of reflux with any methodology - Duration of symptoms for more than 3 months - Taking short or long-term proton pump inhibitors (as needed, treatment start date and expected end date, mg, drug name) - With or without esophagitis - With or without hiatal hernia - With or without helicobacter pylori - GERDQ questionnaire > 8 points Exclusion Criteria: - neoplastic pathologies - patients who have undergone surgery for GERD - systemic pathologies (rheumatic, infectious conditions, feverish state, vascular alterations, endocrine diseases including diabetes, metabolic and neoplastic syndromes), - patients already undergoing manipulative therapy for reflux - patients with active gastric ulcers - congenital or acquired immune diseases - allergic state of any kind - pregnancy - use of intrauterine device - patients undergoing corticosteroid therapy - patients already subjected to manual/respiratory therapy in the last 3 months |
Country | Name | City | State |
---|---|---|---|
Italy | CTFO | Saronno | Varese |
Lead Sponsor | Collaborator |
---|---|
Studio Osteopatico Busto Arsizio |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in GERD-HRQL | best possible score: 0, worst possible score: 50 | At week 2, 4 an 8. | |
Primary | Adverse effects | Type and number. | At week 2, 4 and through study completion (8 weeks) | |
Secondary | Exercise adherence | number of exercises per day performed by participants in OMT + exercise group. | through study completion (8 weeks) | |
Secondary | Change in drugs use | Types, number and frequency of drug assumptions (such as PPI and other oral suspensions) | At week 2, 4 and 8. |
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