Laser acupuncture for middle ear fluid (glue ear) in children
The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children
This trial tests whether adding laser acupuncture to standard decongestant treatment helps children aged 2–10 with middle ear fluid (otitis media with effusion) improve ear function and reduce short-term recurrence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | Indonesia University Academic / other |
| Locations | 1 site (Jakarta Pusat, DKI Jakarta) |
| Trial ID | NCT07242001 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized trial will enroll 32 children aged 2–10 with otitis media with effusion and Type B tympanograms. Participants will receive four sessions over two weeks of either active laser acupuncture or a sham (inactive) laser, together with standard decongestant therapy. The primary outcome is conversion of tympanometry from Type B to Type A immediately after the two-week intervention; secondary outcomes include recurrence at one month and incidence of adverse events. The comparison of active versus sham laser is intended to determine whether laser acupuncture provides a safe, noninvasive adjunct benefit.
Who should consider this trial
Good fit: Ideal candidates are children aged 2–10 with OME confirmed by a Type B tympanogram, no acute ear infection in the prior two weeks, and a parent or guardian able to consent and attend four treatment visits.
Not a fit: Children with prior tympanic membrane perforation or ear surgery, severe complications like cholesteatoma, recent laser acupuncture for OME, unstable systemic disease, or skin lesions at acupuncture sites are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, this could provide a noninvasive adjunct that improves middle ear drainage and lowers short-term recurrence of glue ear in children.
How similar studies have performed: Evidence for acupuncture in otitis media is limited and mixed, and laser acupuncture for pediatric OME is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 2-10 years, both male and female. * Diagnosed with OME with a Type B tympanogram curve, either unilateral or bilateral. * No acute ear infection within the last 2 weeks. * Willingness to participate in the study until completion and signed informed consent from a parent or legal guardian. Exclusion Criteria: * History of tympanic membrane perforation or previous ear surgery. * Presence of severe OME complications, such as permanent hearing loss, tympanosclerosis, or cholesteatoma. * Underwent laser acupuncture therapy for OME within the last three months. * History of unstable systemic disease or other medical conditions that could interfere with the study, such as a history of uncontrolled seizures or epilepsy, a current high fever \>38°C, or malignancy/cancer in the ENT system. * Presence of a mental disorder, inability to communicate well, or being uncooperative. * Presence of wounds or skin lesions at the intended acupuncture point irradiation sites.
Where this trial is running
Jakarta Pusat, DKI Jakarta
- Universitas Indonesia — Jakarta Pusat, DKI Jakarta, Indonesia (Recruiting)
Study contacts
- Principal investigator: Kpek Fkui-Rscm — The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
- Study coordinator: Agitha M Putri
- Email: agitha.melita@ui.ac.id
- Phone: 082114568788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.