Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for Tinnitus (VAS-tinnitus)
研究概览
简要总结
Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.
详细描述
Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. It results from complex interactions between the somatosensory and auditory systems, which involve the musculoskeletal system rather than the ear. The temporomandibular joint, craniocervical junction, cervical vertebrae and neck and shoulder muscles, in particular the sternocleidomastoid (SCM) muscle, upper trapezius and levator scapula, are anatomical regions that can cause somatic tinnitus.
Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 and ≤ 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus
- •Cervical joint range of motion limitation (especially rotation)
- •Modulation of tinnitus in relation to head and neck movements and posture
- •Tenderness in the cervico-occipital muscles Patients reporting cervical pain between >2 and <7 on a visual analogue scale (VAS) on most days of the last month Patients with stable medical and psychological status Patients willing to participate in the study
排除标准
- •Objective tinnitus Subjective tinnitus with hearing loss Meniere's disease History of vertigo Middle ear pathologies History of intracranial pathology History of whiplash injury History of cervical spinal surgery History of active infection, malignancy, inflammatory rheumatic disease or fibromyalgia Pregnancy Patients who have undergone any exercise or physiotherapy programme for the cervical region in the last 3 months
研究组 & 干预措施
Manual therapy + Exercise group
Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. Additionally, patients in the manual therapy group will receive manual therapy on a weekly basis for a total of six sessions.
干预措施: Manual Therapy (Other)
Manual therapy + Exercise group
Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. Additionally, patients in the manual therapy group will receive manual therapy on a weekly basis for a total of six sessions.
干预措施: Exercise (Other)
Exercise group
Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period.
干预措施: Exercise (Other)
结局指标
主要结局
Visual Analogue Scale for Tinnitus (VAS-tinnitus)
时间窗: baseline- week 3 - week 6
The severity of tinnitus will be graded using a 10 cm visual analogue scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely severe tinnitus).
次要结局
- Visual Analogue Scale for cervical pain (VAS-Cervical)(baseline- week 3 - week 6)
- Tinnitus Handicap Index (THI)(baseline- week 3 - week 6)
- Neck disability index (NDI)(baseline- week 3 - week 6)
- Cervical range of motion (ROM)(baseline -week 3- week 6)
- Manual muscle testing (MMT)(baseline - week 3 -week 6)
- Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis(baseline- week 3- week 6)
- Tinnitus provocation with ROM(Baseline- week 3- week 6)
- Tinnitus provocation with MMT(Baseline- week 3- week 6)
- Tinnitus provocation with myofascial trigger point palpation(Baseline- week 3- week 6)
- SF-36 quality of life scores(Baseline- week 3- week 6)
研究者
Tuğba Atan, MD
Assoc. Prof.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital