A new clinical trial sponsored by Indonesia University aims to evaluate the effectiveness of laser acupuncture as a treatment for otitis media with effusion (OME) in children. This study, which is listed as “not yet recruiting,” could provide new insights into the potential benefits and safety of using laser-based therapies in pediatric care.
In this article:
- What changed?
- What is otitis media with effusion?
- Study design and purpose
- How could this impact clinical practice?
- FAQ
- Conclusion
- Disclaimer
What changed?
On November 22, 2025, the clinical trial titled “Laser Acupuncture for Otitis Media With Effusion in Children” was updated on ClinicalTrials.gov. The study is preparing to recruit participants under the sponsorship of Indonesia University. This marks a key step in evaluating an alternative therapeutic option that combines laser technology with acupuncture techniques.
What is otitis media with effusion?
Otitis media with effusion (OME) is a condition characterized by the presence of fluid in the middle ear without signs of an acute infection. It is a common diagnosis in children, often associated with hearing issues and speech delays if left untreated. Managing OME typically involves watchful waiting, medications, or surgical interventions, such as tympanostomy tubes. This trial explores whether laser acupuncture can offer a non-invasive treatment option.
Study design and purpose
The study will compare two interventions: active laser acupuncture and a sham laser procedure. Both groups will use devices to ensure blinding and evaluate the true therapeutic effects of laser acupuncture. The trial’s primary objective is to assess whether laser acupuncture can effectively reduce symptoms of OME and improve quality of life for pediatric patients.
What is the role of laser acupuncture?
Laser acupuncture uses low-level laser therapy applied to acupuncture points. Unlike traditional acupuncture, it replaces needles with a focused light beam, making it a potentially more child-friendly approach. The treatment’s mechanism of action may involve improving middle ear function by reducing inflammation or enhancing local circulation. However, further clinical evidence is required to validate these claims.
How could this impact clinical practice?
If successful, this trial could expand the range of therapeutic options available for treating OME, particularly for patients unsuitable for invasive procedures. By offering a non-invasive approach, laser acupuncture could align with the growing demand for treatments with minimal risks and side effects. Regulatory pathways for approving innovative laser devices in clinical applications could also evolve based on the outcomes of studies like this.
FAQ
- What is the status of the trial?
The trial is listed as “not yet recruiting” as of November 22, 2025. - Who is conducting the study?
Indonesia University is the sponsor of the clinical trial. - What are the main interventions?
The study compares laser acupuncture with a sham laser approach to assess effectiveness. - What is the target population?
The trial focuses on pediatric patients with otitis media with effusion.
Conclusion
This upcoming study signals progress in evaluating innovative therapies for common pediatric conditions. Clinical teams and regulatory professionals should monitor the outcomes to assess how laser acupuncture might integrate into future care standards for otitis media with effusion.
Disclaimer
This article is for informational purposes only and does not constitute medical, legal, or regulatory advice. Professionals should consult official resources or legal counsel for guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07242001?term=medical+device