The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Tympanogram Results
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
Active laser acupuncture and standard decongestants.
干预措施: Laser Acupuncture (Device)
Control Group
Sham laser acupuncture and standard decongestants.
干预措施: Sham Laser Acupuncture (Device)
结局指标
主要结局
Change in Tympanogram Results
时间窗: Baseline and immediately after the final (4th) therapy session at 2 weeks.
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).
次要结局
- Recurrence Rate of OME(From the end of the intervention over a 1-month follow-up period.)
- Time to First Recurrence(From the end of the intervention over a 1-month follow-up period.)
- Incidence of Adverse Events(At the end of each of the four acupuncture therapy sessions.)
研究者
Agitha Melita Putri
Principal Investigator
Indonesia University