Physiotherapy Methods in Tinnitus Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Tinnitus Functional Index (TFI), a Polish validated version (Wrzosek et al., 2016).
研究概览
简要总结
The primary aim of this study is to investigate the effectiveness of cervical spine kinesiotherapy and massage in tinnitus treatment. Furthermore, we investigate if there is a link between cervical spine range of motion and cervical muscles tension and tinnitus.
详细描述
The study is planned with power of 80%. A total of 118 adult patients with subjective tinnitus are divided into two groups: Kinesiotherapy group (n=59) and Waiting list group (n=59).Kinesiotherapy group receives a complex set of cervical spine exercises and neck massage for consecutive 10 working days (entire treatment takes two weeks). Each visit lasts around 30 minutes. Patients from kinesiotherapy group will fill the outcome measures on the following time points: (a) Time point 0 - baseline (b) Time point 1- Two weeks after the baseline
(c) Time point 2- Four weeks after the baseline. Individuals from waiting list group are enrolled on a waiting list and do not receive any treatment. They undergo assessment at three time points corresponding to Kinesiotherapy group i.e Time point 0, Time point 1 and Time point 2.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The responsible investigator is blinded .
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with subjective tinnitus experienced in the ears or in the head (temporary and constant tinnitus) with and without sensorineural hearing loss.
排除标准
- •Other tinnitus treatment in last 6 months,
- •Objective tinnitus,
- •External and middle ear pathology,
- •Acute infections, conditions with fever
- •Bleedings or risk of bleeding
- •Severe respiratory and circulatory insufficiency
- •vasculitis, thrombophlebitis,
- •Pregnancy
- •Acute arthritis and periarticular soft tissues inflammation in the cervical region,
- •Severe pains in different locations,
- •Advanced osteoporosis
- •Uniformed services.
- •Cervical spine instability, cervical disc herniation, cervical radiculopathy.
- •Status post cervical spine surgery.
- •Status post lumbar puncture, status post computed tomography with contrast.
- •Lack of cooperation between the patient and the therapist, cognitive impairment.
- •Atherosclerosis, vertebrobasilar insufficiency.
结局指标
主要结局
Tinnitus Functional Index (TFI), a Polish validated version (Wrzosek et al., 2016).
时间窗: Time point 0: Baseline, Time point 1: 2 weeks after baseline, Time point 2: 4 weeks after baseline
The Tinnitus Functional Index is a comprehensive scale, assessing tinnitus severity, comprising 25 questions. It has eight subscales: intrusiveness, sense of control, cognitive, sleep, auditory, relaxation, quality of life, and emotion. Patients can mark their response on a scale starting from zero (0) to maximum response (10). Maximum possible score of TFI is 250 if the respondent were to mark all 25 TFI items at the maximum value of 10. High scores on TFI scale are interpreted as increased severity of tinnitus and negative impact on patients life. Total TFI score is analyzed at three time points as described above. Statistical analysis is performed using repeated measures ANOVA to evaluate if there is a significant difference in the mean TFI score at the three time points.
次要结局
- Range of motion of cervical spine(as for TFI)
- Tinnitus Handicap Inventory (THI), Polish validated version(as for TFI)
- Visual Analogue Scale (VAS)(as for TFI)
- Cervical muscle tension (MST)(same as for TFI)