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Adherence and recruitment issues.
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To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic manipulative treatment (OMT) | Experimental | 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. |
|
| OMT + breathing exercises. | Active Comparator | 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. |
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| Control | No Intervention | Usual care group (PPI or reflux suppressant) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic manipulative treatment (OMT) | Other | Manual therapy on different area of the body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise adherence | number of exercises per day performed by participants in OMT + exercise group. | through study completion (8 weeks) |
| Change in drugs use | Types, number and frequency of drug assumptions (such as PPI and other oral suspensions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTFO | Saronno | Varese | 21047 | Italy |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| At week 2, 4 and 8. |
| D004066 | Digestive System Diseases |