An interventional study of Laser Acupuncture and Sham Laser Acupuncture in Otitis Media With Effusion, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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.
81 studies on the registry are indexed under Otitis Media with Effusion; 13 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 58 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active laser acupuncture and standard decongestants.
Device: Laser Acupuncture
Sham laser acupuncture and standard decongestants.
Device: Sham Laser Acupuncture
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.
Change in Tympanogram Results
Improvement in middle ear function will be assessed using tympanometry. The outcome is measured as the proportion of participants whose tympanogram curve change from Type B (indicating effusion) to Type A (normal).
Time frame: Baseline and immediately after the final (4th) therapy session at 2 weeks.
Recurrence Rate of OME
The number of participants who experience a recurrence of OME symptoms after the intervention period will be recorded, assessed via weekly monitoring.
Time frame: From the end of the intervention over a 1-month follow-up period.
Time to First Recurrence
ime (in days/weeks) from the end of the intervention to the first documented recurrence of OME will be measured.
Time frame: From the end of the intervention over a 1-month follow-up period.
Incidence of Adverse Events
The total number, type, and severity of adverse events reported by participants will be documented throughout the therapy period.
Time frame: At the end of each of the four acupuncture therapy sessions.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indonesia University