COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY, AND COMBINED THERAPY IN PATIENTS WITH SOMATOSENSORY TINNITUS: A THREE-ARM RANDOMİZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
- 主要终点
- The TPFQ is a validated patient-reported questionnaire
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of Manual Therapy (MT), Tinnitus Retraining Therapy (TRT), and their combination in adults with somatosensory tinnitus. Sixty-five participants will be randomly assigned to one of three parallel groups. Primary and secondary outcomes include tinnitus severity, tinnitus-related disability, neck disability, cervical range of motion, audiological measures, pressure pain threshold, anxiety, depression, and quality of life. Outcomes will be assessed before treatment and immediately after the six-week intervention period.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years.
- •Diagnosis of chronic subjective somatosensory tinnitus persisting for at least 3 months.
- •Tinnitus that can be modulated by head, neck, jaw, or temporomandibular movements and/or cervical muscle palpation.
- •Ability to understand the study procedures and provide written informed consent.
- •Willingness to comply with the treatment protocol and attend all scheduled assessment and treatment sessions.
- •Normal middle ear function as confirmed by immittance (tympanometry) testing.
排除标准
- •Objective or pulsatile tinnitus.
- •Tinnitus duration of less than 3 months.
- •Diagnosis of Ménière's disease, otosclerosis, vestibular schwannoma (acoustic neuroma), or other retrocochlear pathology.
- •Active middle ear disease or abnormal immittance (tympanometry) findings.
- •History of cervical spine surgery or severe cervical trauma.
- •Presence of cervical spine fracture, instability, malignancy, inflammatory rheumatic disease, or other contraindications to manual therapy.
- •Previous temporomandibular joint surgery or severe temporomandibular disorders requiring surgical treatment.
- •Current participation in another clinical trial.
- •Receipt of manual therapy, Tinnitus Retraining Therapy (TRT), or other tinnitus-specific rehabilitation within the previous 3 months.
- •Severe neurological or psychiatric disorders that could interfere with participation or outcome assessment.
- •Pregnancy.
- •Inability to understand study procedures, provide informed consent, or comply with the intervention schedule.
结局指标
主要结局
The TPFQ is a validated patient-reported questionnaire
时间窗: Baseline and Week 6 (end of treatment)
The TPFQ is a validated patient-reported questionnaire used to assess tinnitus severity and its functional impact. Higher scores indicate greater tinnitus-related impairm
The THI is a validated questionnaire
时间窗: Baseline and Week 6
The THI is a validated questionnaire assessing the degree of tinnitus-related handicap. Higher scores indicate greater tinnitus-re
次要结局
未报告次要终点
研究者
Dr. Emine Metin, phd
phd
Suleyman Demirel University