Comparison Of The Effectiveness Of Myofascial Release Exercises and Vagus Nerve Neuromodulation in Tinnitus Patients: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in tinnitus severity
研究概览
简要总结
This randomized controlled trial aims to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises in patient wiht chronic subjective tinnitus. Participants will be randomly assigned into three groups: (1) tVNS group, (2) Myofascial exercise group, and (3) Control group receiving standart medical care. The primary outcome is change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI). Secondary outcomes include tinnitus loudness Visual Analouge Scale for Tinnitus (VAS), sleep quality Pitsburgh Sleep Quality Index (PSQI) and audiometric findings.
详细描述
Tinnitus is a common and distressing condition that significantly impairs quality of life. Recent studies suggest that neuromdulation techniques such as vagus nerve stimulation and physical interventions targeting myofascial structures may reduce tinnitus severity. However, evidence remains limited, and comparative effectiveness of these approaches is not well established.
This single-center randomized controlled trial will compare the effects of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises with a control group receiving only medical treatment. A total of 45 participants with chronic subjective tinnitus will be recruited. Participants will be randomized into three groups and receive 10 intervention sessions over three weeks.
The tVNS group will receive transcutaneous stimulation of the auricular branch of the vagus nerve using a TENS (Everyway N604, Taiwan) device. The myofascial group will undergo guided myofascial release targeting cervical muscles in addition to medical treatment. The control group will continue their medical treatment without additional interventions.
The primary outcome measure will be change in tinnitus-related handicap using the Tinnitus Handicap Inventory (THI). Secondary outcomes will include tinnitus loudness assesed by a Visual Analogue Scale for Tinnitus (VAS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) and audiometric assesments.
The findings from this trial may provide new insights into non-farmacological rehabiliation strategies for tinnitus and clarify the role of neuromodulation compared with physical therapy inreventions.
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
- None
盲法说明
This is an open-label study. Both participants and treating clinicians are not blinded due to the nature of the interventions. Outcome assesor who scoring THI, recording VAS, PSQI is not blinded, those who scores audiometric outcomes are blinded to group assignment to reduce assesment bias.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic subjective tinnitus (>6 months)
- •Ability to understand and provide written informed consent
- •Willingness to comply with study procedures and intervention schedule
- •Resistant for medical treatment for subjective tinnitus
- •Impacted daily living by tinnitus
排除标准
- •Diagnoses such as auditory hallucinations, Meniere's disease, vestibular tumor, vertigo, or sudden hearing loss
- •Trauma or surgical interventions involving the neck, jaw, or head within the 6 months
- •Epilepsy or presence of a cardiac pacemaker (contraindication for tVNS)
- •History of acute psychiatric disorders
- •Use of ototoxic medications
- •Physical limitations that prevent participation in exercise interventions.
研究组 & 干预措施
Transcutaneous Vagus Nerve Stimulation
10 sessions over 3 weeks; auricular stimulation of the vagus nerve using TENS; session duration 30 min.
干预措施: Transcutaneous Vagus Nerve Stimulation (Device)
Transcutaneous Vagus Nerve Stimulation
10 sessions over 3 weeks; auricular stimulation of the vagus nerve using TENS; session duration 30 min.
干预措施: Standard medical treatment (Other)
Myofascial Exercise Group
10 supervised sessions over 3 weeks; targeting cervical muscles.
干预措施: Myofascial Release Exercises (Behavioral)
Myofascial Exercise Group
10 supervised sessions over 3 weeks; targeting cervical muscles.
干预措施: Standard medical treatment (Other)
Control Group
Standart Medical Care without additional inerventions
结局指标
主要结局
Change in tinnitus severity
时间窗: Baseline to post-intervention (3 weeks)
Measured using the Tinnitus Handicap Inventory (THI), which assesses the impact of tinnitus on daily functioning.
次要结局
- Audiometric measures(Baseline to post-intervention (3 weeks))
- Tinnitus Loudness(Baseline to post-intervention (3 weeks))
- Sleep quality(Baseline to post-intervention (3 weeks))
研究者
Maria SARIKIR
Bsc
Necmettin Erbakan University