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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mark D Unger, D.O., M.S.
- 電話番号：434-582-2773
- メール：mdunger@liberty.edu
研究連絡先のバックアップ
- 名前：Sarah Vidal, B.S.
- 電話番号：8137200207
- メール：sstephens72@liberty.edu
研究場所
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Virginia
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Lynchburg、Virginia、アメリカ、24501
- Blue Ridge Ear, Nose and Throat
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コンタクト：
- Sarah Vidal, B.S.
- 電話番号：8137200207
- メール：sstephens72@liberty.edu
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副調査官：
- Jay Cline, M.D.
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Lynchburg、Virginia、アメリカ、24502
- Collaborative Healthplex
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コンタクト：
- Sarah Vidal
- 電話番号：8137200207
- メール：sstephens72@liberty.edu
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副調査官：
- Mark D Unger, DO, MS
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副調査官：
- Joy Palmer, DO
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副調査官：
- Kirsten Madea, DO
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：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.
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|
他の：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.
他の名前：
|
|
他の：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.
他の名前：
|
|
実験的：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Final Surgical Decision
時間枠：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.
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At the time of the participant's pre-operative ENT visit, following all four study visits.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tympanometry Data
時間枠：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".
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Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
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Audiometry Data
時間枠：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.
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Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
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Otitis Media Quality of Life Survey (OM-6)
時間枠：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.
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This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
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Pediatric Quality of Life Inventory (PedsQL)
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年5月31日
研究の完了 (推定)
2028年5月31日
試験登録日
最初に提出
2026年6月2日
QC基準を満たした最初の提出物
2026年6月6日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月6日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB-FY25-26-44
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Only designated research personnel will have access to identifiable participant data.
For the purposes of data analysis, the information will be de-identified.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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