Laser Acupuncture for Otitis Media With Effusion in Children
The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children
Indonesia University
32 participants
Dec 29, 2025
INTERVENTIONAL
Summary
The goal of this clinical trial is to learn if laser acupuncture (LA) can improve middle ear function and reduce the recurrence of Otitis Media with Effusion (OME) in children. The main questions it aims to answer are: Does LA, when combined with standard treatment (decongestants), improve middle ear function as measured by tympanometry immediately after the 2-week intervention? Does LA, when combined with standard treatment, reduce the recurrence rate of OME as monitored over a 1-month period after the intervention? What is the safety profile of LA in this population, as measured by the incidence of adverse events? Researchers will compare active LA to sham LA (a placebo procedure with an inactive device) to determine if LA leads to meaningful improvements in children with OME. Participants will: Complete an initial assessment using tympanometry to confirm the diagnosis. Receive four sessions of either active LA or sham LA over a 2-week period. Complete a final assessment using tympanometry after the final session. Participate in a 1-month follow-up period with weekly monitoring for recurrence.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
Laser Acupuncture is performed for 40 seconds per point at acupoints SI19, TE17, TE5, and LI4 using a low-level laser device (785 nm, 50 mW, delivering an energy density of 12.73 J/cm²). The device is activated to emit laser energy. Standard aseptic procedures are followed. The laser applicator is held perpendicular to the skin without pressure. Participants continue their routine decongestant therapy.
Sham Laser Acupuncture involves placing the applicator of an inactive laser device onto the same acupoints (SI19, TE17, TE5, and LI4) for the same duration as the active group. The device is turned on, but the start button is not pressed, so no laser energy is emitted. All procedures, including aseptic preparation, timing, and handling of the device, are performed identically to the intervention group to maintain blinding. Participants will wear ear covers and the device's LCD panel will be covered. Participants continue their routine decongestant therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07242001