Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- presence of inflammatory markers in middle ear effusion
研究概览
简要总结
Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control. 50 Children in the acupuncture group will receive standard treatment combined with acupuncture for 3 months. 50 Children in the control group will receive standard treatment only, for the same time period. After 3 months, both groups will be reassessed for OME. Children with no improvement from both groups will be assigned for tympanostomy.
Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be collected, analyzed and evaluated for group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •otherwise healthy children ages 2-8 years
- •autoscopic OME diagnosis
- •tympanometry type B
- •conductive hearing impairment of 30 decibel or more
- •who are at watchful waiting treatment for 3 months
- •signed parental consent.
排除标准
- •lack of parental consent
- •known coagulopathy
- •past tympanostomy
- •regular intake of steroids or cytotoxic drugs
研究组 & 干预措施
acupuncture
acupuncture treatment
干预措施: acupuncture (Device)
standard treament
watchful waiting
结局指标
主要结局
presence of inflammatory markers in middle ear effusion
时间窗: 3 months
after 3 months, patients in both groups will be reevaluated for OME by micro otoscopy and tympanometry, including an audiogram. patients with no improvement, will be submitted for tympanostomy in accordance with standard criteria. middle ear effusion will be collected and analysed by ELISA for viral/bacterial RNA presence and flow cytometry for leukocyte presence. results will be statistically processed for between group differences.
次要结局
- acupuncture effect on OME(3 months)