Gastro-oesophageal Reflux Disease
Conditions
Keywords
GERD, Osteopathic manipulative treatment, OMT, Manual therapy
Brief summary
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
Interventions
Manual therapy on different area of the body.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in GERD-HRQL | At week 2, 4 an 8. | best possible score: 0, worst possible score: 50 |
| Adverse effects | At week 2, 4 and through study completion (8 weeks) | Type and number. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise adherence | through study completion (8 weeks) | number of exercises per day performed by participants in OMT + exercise group. |
| Change in drugs use | At week 2, 4 and 8. | Types, number and frequency of drug assumptions (such as PPI and other oral suspensions) |
Countries
Italy