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The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children
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.
This is a double-blind, randomized controlled trial designed to assess the effectiveness and safety of laser acupuncture as an adjunctive therapy for Otitis Media with Effusion (OME) in children. A total of 32 participants aged 2-10 years will be randomly assigned to either a treatment group (receiving active laser acupuncture and standard decongestants) or a control group (receiving sham laser acupuncture and standard decongestants). The intervention consists of four sessions over two weeks. The primary outcome is the improvement of middle ear function, measured by a change in tympanometry results from Type B to Type A. Secondary outcomes include the rate of OME recurrence at one month and the incidence of adverse events during the therapy period. This study will provide evidence on whether laser acupuncture is a beneficial, non-invasive treatment option for this common pediatric condition.
Age
2 - 10 years
Sex
ALL
Healthy Volunteers
No
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Start Date
December 29, 2025
Primary Completion Date
May 31, 2026
Completion Date
June 30, 2026
Last Updated
February 5, 2026
32
ESTIMATED participants
Laser Acupuncture
DEVICE
Sham Laser Acupuncture
DEVICE
Lead Sponsor
Indonesia University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04395261