Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

Studio Osteopatico Busto Arsizio

Status and phase: Enrolling; Phase 2

Conditions: Gastro-oesophageal Reflux Disease

Treatments: Other: Osteopathic manipulative treatment (OMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06317675

ct9873

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Osteopathic manipulative treatment (OMT)

Experimental group

Description:

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.

Treatment:

Other: Osteopathic manipulative treatment (OMT)

OMT + breathing exercises.

Active Comparator group

Description:

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.

Treatment:

Other: Osteopathic manipulative treatment (OMT)

Control

No Intervention group

Description:

Usual care group (PPI or reflux suppressant)