Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease
Phase 2
Recruiting
- Conditions
- Gastro-oesophageal Reflux Disease
- Interventions
- Other: Osteopathic manipulative treatment (OMT)
- Registration Number
- NCT06317675
- Lead Sponsor
- Studio Osteopatico Busto Arsizio
- Brief Summary
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OMT + breathing exercises. Osteopathic manipulative treatment (OMT) This group will receive OMTs and five breathing exercises to perform daily at home. A recorded video of the exercises will be provided to participants in this group. Osteopathic manipulative treatment (OMT) Osteopathic manipulative treatment (OMT) Participants will receive four OMTs at week 1, 2, 4 and 8. Joint mobilization techniques for ribs, cervical and dorsal spine, as well as visceral treatment, soft-tissue release on diaphragm and abdominal wall will be used.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
CTFO
🇮🇹Saronno, Varese, Italy