Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

Phase 2

Recruiting

• Conditions: Gastro-oesophageal Reflux Disease

• 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

Study Timeline

• Study Start: 2024-02-18
• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-19
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-12
• Study Completion: 2026-04

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

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