Osteopathic Manipulative Treatment for Patients Affected by Symptoms Related to Gastro-oesophageal Reflux Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Mean change in GERD-HRQL
研究概览
简要总结
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Osteopathic manipulative treatment (OMT) (Other)
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.
干预措施: Osteopathic manipulative treatment (OMT) (Other)
Control
Usual care group (PPI or reflux suppressant)
结局指标
主要结局
Mean change in GERD-HRQL
时间窗: At week 2, 4 an 8.
best possible score: 0, worst possible score: 50
Adverse effects
时间窗: At week 2, 4 and through study completion (8 weeks)
Type and number.
次要结局
- Exercise adherence(through study completion (8 weeks))
- Change in drugs use(At week 2, 4 and 8.)