Otitis MediaNCT07639775
Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
A study testing Experimental Osteopathic Manipulative Treatment (OMT) Protocol in people with Otitis Media and Otitis Media Effusion, run by Sarah Vidal at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Otitis Media, Otitis Media Effusion, Otitis Media Recurrent
- What is being tested?
- Experimental Osteopathic Manipulative Treatment (OMT) Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Blue Ridge Ear, Nose and Throat
Lynchburg, Virginia, 24501
Sarah Vidal, B.S., 8137200207, sstephens72@liberty.edu
Jay Cline, M.D.
Collaborative Healthplex
Lynchburg, Virginia, 24502
Sarah Vidal, 8137200207, sstephens72@liberty.edu
Mark D Unger, DO, MS
About this study
Official title: 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:
Read more
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.
- Conditions
- Otitis Media, Otitis Media Effusion, Otitis Media Recurrent, Otitis Media With Effusion in Children, Otitis Media Chronic, Otitis Media in Children
- Being tested
- Experimental Osteopathic Manipulative Treatment (OMT) Protocol, Control Osteopathic Manipulative Treatment (OMT) Protocol
- Medical subject headings
- Otitis Media, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Osteopathic Manipulative Treatment (OMT) ProtocolOther
Also called True Intervention
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.
Control Osteopathic Manipulative Treatment (OMT) ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Distal Region OMT Only | Placebo comparator | Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol. Receives: Other: Control Osteopathic Manipulative Treatment (OMT) Protocol |
| Intermediate Group: Distal Region OMT then Targeted OMT | Other | Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol. Receives: Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol; Other: Control Osteopathic Manipulative Treatment (OMT) Protocol |
| Intermediate Group: Targeted OMT then Distal Region OMT | Other | Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol. Receives: Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol; Other: Control Osteopathic Manipulative Treatment (OMT) Protocol |
| Targeted OMT Only | Experimental | Participants assigned to this group receive a double dose of the experimental OMT protocol. Receives: Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Surgical Decision
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.
Measured: At the time of the participant's pre-operative ENT visit, following all four study visits.
Secondary outcomes (4)
Tympanometry Data
Objective measurement of fluid and/or pressure behind the tympanic membrane. Results reported as "Type A", "B", or "C".
Measured: Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Audiometry Data
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Vidal
- Sponsor type
- University, hospital or other
- Collaborators
- KR Love Quantitative Consulting and Collaboration
- Responsible party
- Sponsor-investigator, Sarah Vidal, Liberty University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639775
- Sponsor's protocol ID
- IRB-FY25-26-44
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.
Publications
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.
PubMed 40481343Mills 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.
PubMed 12963590
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07639775
- Acronym / sponsor ID
- IRB-FY25-26-44
- Conditions
- Otitis Media, Otitis Media Effusion, Otitis Media Recurrent, Otitis Media With Effusion in Children, Otitis Media Chronic, Otitis Media in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sarah VidalUniversity, hospital or other
- Collaborators
- KR Love Quantitative Consulting and Collaboration
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Distal Region OMT Only | Placebo comparator | Other: Control Osteopathic Manipulative Treatment (OMT) ProtocolParticipants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol. |
| Intermediate Group: Distal Region OMT then Targeted OMT | Other | Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol, Other: Control Osteopathic Manipulative Treatment (OMT) ProtocolParticipants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol. |
| Intermediate Group: Targeted OMT then Distal Region OMT | Other | Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol, Other: Control Osteopathic Manipulative Treatment (OMT) ProtocolParticipants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol. |
| Targeted OMT Only | Experimental | Other: Experimental Osteopathic Manipulative Treatment (OMT) ProtocolParticipants assigned to this group receive a double dose of the experimental OMT protocol. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Osteopathic Manipulative Treatment (OMT) ProtocolAlso: True InterventionThe 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. | Other | Intermediate Group: Distal Region OMT then Targeted OMT, Intermediate Group: Targeted OMT then Distal Region OMT, Targeted OMT Only |
| Control Osteopathic Manipulative Treatment (OMT) ProtocolThe 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. | Other | Distal Region OMT Only, Intermediate Group: Distal Region OMT then Targeted OMT, Intermediate Group: Targeted OMT then Distal Region OMT |
Primary outcome
Final Surgical Decision
Time frame: 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.
4 secondary outcomes
Tympanometry Data
Time frame: Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Audiometry Data
Time frame: 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)
Time frame: 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)
Time frame: This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- BackgroundCarreiro JE. An Osteopathic Approach to Children. 2nd ed. Churchill Livingstone; 2009.
- Background: PubMed 40481343Kim 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.
- Background: PubMed 12963590Mills 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.
- Individual participant dataSharing planned: No. Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.
Related trials for Otitis Media
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Active, not recruiting
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Acute Otitis Media (AOM)
Active, not recruitingObservational study
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Nasopharyngeal Colonization and Acute Otitis Media
Not yet recruitingPhase 4
Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children
Acute Otitis Media, AOM - Acute Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Osteopathic Manipulative Treatment (OMT) Protocol in people with Otitis Media and Otitis Media Effusion, run by Sarah Vidal at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark D Unger, D.O., M.S. (434-582-2773, mdunger@liberty.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Surgical Decision (time frame: At the time of the participant's pre-operative ENT visit, following all four study visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07639775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.