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Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06317675
Enrollment
26
Registered
2024-03-19
Start date
2024-02-18
Completion date
2026-01-11
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-oesophageal Reflux Disease

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

OTHEROsteopathic manipulative treatment (OMT)

Manual therapy on different area of the body.

Sponsors

Studio Osteopatico Busto Arsizio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Mean change in GERD-HRQLAt week 2, 4 an 8.best possible score: 0, worst possible score: 50
Adverse effectsAt week 2, 4 and through study completion (8 weeks)Type and number.

Secondary

MeasureTime frameDescription
Exercise adherencethrough study completion (8 weeks)number of exercises per day performed by participants in OMT + exercise group.
Change in drugs useAt week 2, 4 and 8.Types, number and frequency of drug assumptions (such as PPI and other oral suspensions)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026