The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tinnitus Questionnaire
研究概览
简要总结
TMD treatment, based on state of the art knowledge derived from clinical studies will be applied in patients with tinnitus and TMD. When this approach proves to be useful for the treatment of tinnitus, it offers a new therapeutic option for patients with tinnitus. To understand how TMD treatment works for patients with tinnitus, we will analyse mediating factors, i.e. factors that contribute to the therapeutic effect. To help clinicians in their clinical process we will identify prognostic indicators, i.e. factors that predict a positive or negative outcome of TMD treatment. This can provide a helpful tool in clinical practice.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included when suffering from somatic tinnitus, attributed to TMD, which has been stable for at least 3 months.
- •Tinnitus Functional Index score between 25 and 90
排除标准
- •clear otological or neurological causes of the tinnitus such as Menière's disease, severe depression (diagnosed by a psychologist), progressive middle ear pathology, intracranial pathology
- •traumatic cervical spine or temporomandibular injury in the past 6 months
- •previous surgery in the orofacial area
- •in case physical therapy treatment directed to the orofacial area is contra-indicated
- •if the patient received TMD treatment in the past 2 months
- •drug intake that can affect the outcome measures
结局指标
主要结局
Tinnitus Questionnaire
时间窗: Baseline, 9 weeks, 18 weeks, 27 weeks
Questionnaire to measure the change in tinnitus related distress
次要结局
- Specific anamnestic questions(Baseline)
- Hyperacusis Questionnaire(Baseline)
- Visual analogue scale for tinnitus loudness(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Tinnitus Analysis(Baseline)
- Speech in noise test(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Tinnitus Functional Index(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Hospital anxiety and depression scale(Baseline)
- Pain on palpation of masseter, temporalis and temporomandibular joint(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Auditory evoked potentials measurement(Baseline, 18 weeks)
- TMD pain screener(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Dynamic investigation of the temporomandibular joint(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Mouth opening(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Static investigation of the temporomandibular joint(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Pain pressure threshold(Baseline, 9 weeks, 18 weeks, 27 weeks)
- Pure tone audiometry(Baseline)
研究者
Sarah Michiels
Post-doctoral researcher
Universiteit Antwerpen