Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
2026年6月6日 更新者：Sarah Vidal
The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial
The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement.
The main question it aims to answer is:
Can a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media?
Researchers will compare children who receive the standardized OMT protocol with children who receive a placebo/control manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery.
Participants will:
- Attend 4 weekly study visits before their final ENT surgical decision.
- Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization.
- Complete study-related assessments and questionnaires related to ear symptoms and quality of life.
- Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mark D Unger, D.O., M.S.
- 电话号码：434-582-2773
- 邮箱：mdunger@liberty.edu
研究联系人备份
- 姓名：Sarah Vidal, B.S.
- 电话号码：8137200207
- 邮箱：sstephens72@liberty.edu
学习地点
-
-
Virginia
-
Lynchburg、Virginia、美国、24501
- Blue Ridge Ear, Nose and Throat
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接触：
- Sarah Vidal, B.S.
- 电话号码：8137200207
- 邮箱：sstephens72@liberty.edu
-
副研究员：
- Jay Cline, M.D.
-
Lynchburg、Virginia、美国、24502
- Collaborative Healthplex
-
接触：
- Sarah Vidal
- 电话号码：8137200207
- 邮箱：sstephens72@liberty.edu
-
副研究员：
- Mark D Unger, DO, MS
-
副研究员：
- Joy Palmer, DO
-
副研究员：
- Kirsten Madea, DO
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 6 months to less than 7 years. (All participants)
- Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)
- Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)
- At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)
Exclusion Criteria:
- Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants)
- History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)
- History of tympanic membrane perforation. (All participants)
- Presence of preauricular pits. (All participants)
- Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Distal Region OMT Only
Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
|
The Control Intervention is a protocol of genuine OMT applied to the Sacrum, Pelvis and Lower Extremity body regions plus standard of care.
This Control Intervention is conceptualized as inert in the study population.
|
|
其他：Intermediate Group: Distal Region OMT then Targeted OMT
Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol.
|
The Control Intervention is a protocol of genuine OMT applied to the Sacrum, Pelvis and Lower Extremity body regions plus standard of care.
This Control Intervention is conceptualized as inert in the study population.
The Experimental Intervention is a standardized OMT protocol targeting the head, neck, thoracic, and lymphatic regions, selected to address anatomic and physiologic factors implicated in eustachian tube function, middle ear ventilation, and lymphatic drainage.
The protocol consists of widely taught, non-invasive osteopathic techniques delivered in a fixed sequence and duration.
其他名称：
|
|
其他：Intermediate Group: Targeted OMT then Distal Region OMT
Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol.
|
The Control Intervention is a protocol of genuine OMT applied to the Sacrum, Pelvis and Lower Extremity body regions plus standard of care.
This Control Intervention is conceptualized as inert in the study population.
The Experimental Intervention is a standardized OMT protocol targeting the head, neck, thoracic, and lymphatic regions, selected to address anatomic and physiologic factors implicated in eustachian tube function, middle ear ventilation, and lymphatic drainage.
The protocol consists of widely taught, non-invasive osteopathic techniques delivered in a fixed sequence and duration.
其他名称：
|
|
实验性的：Targeted OMT Only
Participants assigned to this group receive a double dose of the experimental OMT protocol.
|
The Experimental Intervention is a standardized OMT protocol targeting the head, neck, thoracic, and lymphatic regions, selected to address anatomic and physiologic factors implicated in eustachian tube function, middle ear ventilation, and lymphatic drainage.
The protocol consists of widely taught, non-invasive osteopathic techniques delivered in a fixed sequence and duration.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Final Surgical Decision
大体时间：At the time of the participant's pre-operative ENT visit, following all four study visits.
|
Following the final intervention for any given participant, the ENT physician, in conjunction with the parent/guardian, will determine whether to proceed with tympanostomy tube placement, defer, or cancel based on clinical status.
This decision constitutes the primary outcome of the study.
|
At the time of the participant's pre-operative ENT visit, following all four study visits.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tympanometry Data
大体时间：Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
Objective measurement of fluid and/or pressure behind the tympanic membrane.
Results reported as "Type A", "B", or "C".
|
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
|
Audiometry Data
大体时间：Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
An objective measurement of hearing ability in decibels, with the ability to distinguish between conductive and sensorineural hearing loss.
Typically done in conjunction with tympanometry.
|
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
|
Otitis Media Quality of Life Survey (OM-6)
大体时间：This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
|
A parent-proxy survey used for infants and young children.
It tracks six core domains: physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns.
The six items on OM-6 questionnaire are graded by caregiver on a seven-point scale where 1 indicates no problem and 7 indicates extreme problem.
The individual scores are summed up and divided by 6 to get an overall mean score.
Higher scores indicate worse outcome and lower scores indicate better outcome.
|
This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
|
|
Pediatric Quality of Life Inventory (PedsQL)
大体时间：This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
|
The PedsQL Inventory is designed to measure health-related quality of life (HRQOL) in healthy children and those with acute or chronic health conditions.
It is divided into specific age brackets to ensure developmentally appropriate questions.
For participants 6 months to 2 years old, the PedsQL Infant Scales will be used.
For participants 3 to 6 years old, the PedsQL 4.0 Generic Core Scales - Parent Proxy Report will be used.
Parents/caregivers must complete these as proxy-reports.
The PedsQL uses a standard 5-point Likert scale (0 = Never a problem; 1 = Almost never a problem; 2 = Sometimes a problem; 3 = Often a problem; 4 = Almost always a problem).
Answers are reverse-scored and transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) and the mean is taken.
Higher scores indicate a better outcome.
|
This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Carreiro JE. An Osteopathic Approach to Children. 2nd ed. Churchill Livingstone; 2009.
- Kim CH, McCray LR, Nguyen SA, Shermetaro C, Robbins WK. Use of osteopathic manipulation techniques for management of acute otitis media in pediatric patients: a scoping review. Eur Arch Otorhinolaryngol. 2025 Nov;282(11):5519-5528. doi: 10.1007/s00405-025-09492-9. Epub 2025 Jun 6.
- Mills MV, Henley CE, Barnes LL, Carreiro JE, Degenhardt BF. The use of osteopathic manipulative treatment as adjuvant therapy in children with recurrent acute otitis media. Arch Pediatr Adolesc Med. 2003 Sep;157(9):861-6. doi: 10.1001/archpedi.157.9.861.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2028年5月31日
研究完成 (估计的)
2028年5月31日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月6日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月6日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB-FY25-26-44
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Only designated research personnel will have access to identifiable participant data.
For the purposes of data analysis, the information will be de-identified.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.