NCT03131674撤回不适用
The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Tinnitus Questionnaire
研究概览
简要总结
This study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. This study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions.
These inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with subjective tinnitus (Tinnitus Functional Index between 25 and 90 point) in combination with self-reported neck complaints (Neck Bournemouth Questionnaire > 13 points) are included in case one of the following is present:
- •Tinnitus and neck complaints increase and decrease together
- •Tinnitus is low-pitched and increases during inadequate neck postures
排除标准
- •Tinnitus related to Ménière's disease, clear otological or neurological causes
- •Serious depression
- •Contra-indications for cervical spine treatment
- •Patient already received cervical physical therapy in the past 2 months
研究组 & 干预措施
Delayed treatment
Experimental
干预措施: Cervical physical therapy (Other)
Direct treatment
Experimental
干预措施: Cervical physical therapy (Other)
结局指标
主要结局
Tinnitus Questionnaire
时间窗: Baseline, 9 weeks, 18 weeks
change in tinnitus distress after treatment and after follow-up
次要结局
- Tinnitus Functional Index(Baseline, 9 weeks, 18 weeks)
- Neck Bournemouth Questionnaire(Baseline, 9 weeks, 18 weeks)
- Change in Auditory evoked potentials(Baseline, 9 weeks)
- Change in Manual Rotation test(Baseline, 9 weeks)
- change in adapted Spurling test(baseline, 9 weeks)
- change in presence of active triggerpoints(baseline, 9 weeks)
- change in Craniocervical flexion test(baseline, 9 weeks)
- change in Coordination and strength test of cervical extensor muscles(baseline, 9 weeks)
- change in Speech in noise test(baseline, 9 weeks)
研究者
Sarah Michiels
Post-doctoral researcher
Universiteit Antwerpen
研究点 (1)
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