Laser Acupuncture for Otitis Media With Effusion in Children

N/ARecruitingNCT07242001

Indonesia University32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Laser AcupunctureDEVICE

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 AcupunctureDEVICE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.