Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

NCT ID: NCT06317675

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-18

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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Conditions

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Gastro-oesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Osteopathic manipulative treatment (OMT)

Intervention Type OTHER

Manual therapy on different area of the body.

OMT + breathing exercises.

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.

Group Type ACTIVE_COMPARATOR

Osteopathic manipulative treatment (OMT)

Intervention Type OTHER

Manual therapy on different area of the body.

Control

Usual care group (PPI or reflux suppressant)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Osteopathic manipulative treatment (OMT)

Manual therapy on different area of the body.

Intervention Type OTHER

Other Intervention Names

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Manipulative treatment Manual therapy

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Studio Osteopatico Busto Arsizio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CTFO

Saronno, Varese, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carolina Lavazza

Role: CONTACT

+39 02 96701013

Facility Contacts

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+39 02 96701013

Role: primary

Other Identifiers

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ct9873

Identifier Type: -

Identifier Source: org_study_id

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