Laser Acupuncture for Otitis Media With Effusion in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Otitis Media With Effusion
• Intervention / Treatment: Device: Laser Acupuncture; Device: Sham Laser Acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agitha M Putri; Phone Number: 082114568788; Email: agitha.melita@ui.ac.id

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Universitas Indonesia
      • Contact: Agitha M Putri; Phone Number: 082114568788; Email: agitha.melita@ui.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Active laser acupuncture and standard decongestants.	Device: 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 Comparator: Control Group; Sham laser acupuncture and standard decongestants.	Device: Sham Laser Acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and immediately after the final (4th) therapy session at 2 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At the end of each of the four acupuncture therapy sessions.

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KPEK FKUI-RSCM, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: 25-09-1474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No