Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease
1 other identifier
interventional
30
1 country
1
Brief Summary
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2024
CompletedFirst Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMarch 25, 2024
March 1, 2024
1.8 years
February 29, 2024
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in GERD-HRQL
best possible score: 0, worst possible score: 50
At week 2, 4 an 8.
Adverse effects
Type and number.
At week 2, 4 and through study completion (8 weeks)
Secondary Outcomes (2)
Exercise adherence
through study completion (8 weeks)
Change in drugs use
At week 2, 4 and 8.
Study Arms (3)
Osteopathic manipulative treatment (OMT)
EXPERIMENTALParticipants 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.
OMT + breathing exercises.
ACTIVE COMPARATORThis 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.
Control
NO INTERVENTIONUsual care group (PPI or reflux suppressant)
Interventions
Manual therapy on different area of the body.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CTFO
Saronno, Varese, 21047, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 19, 2024
Study Start
February 18, 2024
Primary Completion
December 1, 2025
Study Completion
April 1, 2026
Last Updated
March 25, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share