Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

Gastro-oesophageal Reflux Disease Clinical Trial

Official title:

Osteopathic Manipulative Treatment for Patients Affected by Symptoms Related to Gastro-oesophageal Reflux Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317675
• Other study ID #: ct9873
• Status: Recruiting
• Phase: Phase 2
• Start date: February 18, 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Studio Osteopatico Busto Arsizio
• Contact: Carolina Lavazza
• Phone: +39 02 96701013
• Email: carolina.lavazza[@]docenti.aimoedu.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastro-oesophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

Other:
• Osteopathic manipulative treatment (OMT)
Manual therapy on different area of the body.

Locations

Country	Name	City	State
Italy	CTFO	Saronno	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Studio Osteopatico Busto Arsizio

Country where clinical trial is conducted

Italy, 

Outcome

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.