Effect of Osteopathic Manipulative Medicine (OMM) on the Duration of Middle Ear Effusion in Children Following Diagnosis of Acute Otitis Media, as Measured by Tympanograms and Acoustic Reflectometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
研究概览
简要总结
The purpose of this study is to determine if the application of osteopathic manipulative medicine speeds the rate of resolution of middle ear effusion (fluid) in children following an episode of acute otitis media.
详细描述
Acute otitis media is a significant world wide problem commonly affecting children between 6 and 18 months, and is the most frequent reason for childhood illness visits to a physician in the US. By three years of age, 50-70% of children will have had one episode, while one-third will have had more than three. Persistence of middle ear effusion following an episode of acute otitis media is thought to predispose the child to recurrent infection. The standard care for recurrent acute otitis media includes long term antibiotic prophylaxis and surgery. The risks of standard care are recognized, and alternative means of treating acute disease and preventing recurrent otitis media are needed.
For over a century, osteopathic physicians have reported favorable clinical outcomes in children treated with osteopathic manipulative medicine (OMM) in addition to standard medical care. To determine if a standardized OMM protocol will reduce the duration of middle ear effusion (MEE) after onset of acute otitis media, we outline a prospective, randomized, blinded, multi-center efficacy study of children ages six months to two years with a single episode of acute otitis media. Subjects will be randomized into one of two treatment groups: standard care plus OMM and standard care only. Subjects will be followed for one month to determine rate of resolution of middle ear effusion following onset of the acute otitis media. Statistical analysis will determine any differences between subjects in the two treatment groups.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 2 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months up to second birthday
- •Documented presence of acute otitis media following the 2004 AAP/AAFP Guidelines within 3 days of entry into the study
排除标准
- •Chromosomal abnormalities
- •Major congenital malformations of the head and neck, including torticollis
- •Immunologic abnormalities or deficiencies
- •Any prior ear-nose-throat surgery performed as a treatment for otitis media
- •Any tube placement surgery scheduled during the four weeks of the study.
- •Normal tympanograms at entry into study
研究组 & 干预措施
Standard Care Plus OMM
Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.
干预措施: osteopathic manipulative medicine (OMM) (Procedure)
Standard Care Only
Subjects will receive standard care only for otitis media from their regular referring physician
结局指标
主要结局
Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
时间窗: 1 month
For this study, the tympanogram was chosen to measure middle ear effusion. Three tympanogram readings from each ear included in the study were taken at the beginning of each of 5 Study Visits. For the intervention group, a second set of 3 tympanograms was taken immediately after the OMM on Visits 1, 2 and 3. All tympanograms were sent to a blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. "A" and "C1" readings were considered "normal" and "B" and "C2" readings were considered "abnormal". The extent to which the tympanogram readings of each ear included in the study changed from baseline over 4 weeks was computed by crosstabulating the intervention group by the normal/abnormal changes in tympanograms.
次要结局
- Change in Middle Ear Effusion Immediately After OMM at Study Visit 2(Before and immediately after OMM at study visit 2)
- Change in Middle Ear Effusion Immediately After OMM at Study Visit 3(Before and immediately after OMM at study visit 3)
研究者
Karen M. Steele, D.O., FAAO
Professor Emerita
West Virginia School of Osteopathic Medicine
