Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

March 21, 2024 updated by: Studio Osteopatico Busto Arsizio

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Varese
      • Saronno, Varese, Italy, 21047
        • Recruiting
        • CTFO
        • Contact:
          • +39 02 96701013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Osteopathic manipulative treatment (OMT)
Manual therapy on different area of the body.
Other Names:
  • Manual therapy
  • Manipulative treatment
Active Comparator: 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.
Other: Osteopathic manipulative treatment (OMT)
Manual therapy on different area of the body.
Other Names:
  • Manual therapy
  • Manipulative treatment
No Intervention: Control
Usual care group (PPI or reflux suppressant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in GERD-HRQL
Time Frame: At week 2, 4 an 8.
best possible score: 0, worst possible score: 50
At week 2, 4 an 8.
Adverse effects
Time Frame: At week 2, 4 and through study completion (8 weeks)
Type and number.
At week 2, 4 and through study completion (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in drugs use
Time Frame: At week 2, 4 and 8.
Types, number and frequency of drug assumptions (such as PPI and other oral suspensions)
At week 2, 4 and 8.
Exercise adherence
Time Frame: through study completion (8 weeks)
number of exercises per day performed by participants in OMT + exercise group.
through study completion (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Studio Osteopatico Busto Arsizio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ct9873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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