Laser Acupuncture for Otitis Media With Effusion in Children

University of Indonesia (UI)

Status: Enrolling

Conditions: Otitis Media With Effusion

Treatments: Device: Sham Laser Acupuncture; Device: Laser Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07242001

25-09-1474

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Active laser acupuncture and standard decongestants.

Treatment:

Device: Laser Acupuncture

Control Group

Sham Comparator group

Description:

Sham laser acupuncture and standard decongestants.

Treatment:

Device: Sham Laser Acupuncture