Usefullnes of Local Lidocaine Paravertebral Cervical Injection on Cervicogenic Dizziness Symptoms Management: a Randomzied Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Dizziness Handicap Inventory
研究概览
简要总结
at least 42 patients affected by cervicogenic dizziness will be allocated to the experimental group or in the placebo group. in the first group patients will received 2 paravertebral intramuscular injection of lidocaine 0.5% while in the placebo group they will received saline solution with the same injection technique. patients will be evaluated by subjective and objective testing before the treatment, immediatly and 3 months after the treatment.
详细描述
at least 42 patients affected by cervicogenic dizziness will be allocated to the experimental group or in the placebo group. in the first group patients will received 2 paravertebral intramuscular injection of lidocaine 0.5% while in the placebo group they will received saline solution with the same injection technique. patients will be evaluated by subjective and objective testing before the treatment, immediatly and 3 months after the treatment. subjective testing will include dizziness handicap inventory, Neck Disability Index, Neck Pain Intensity, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression Scale. Objective testing will include cervical range of motion, joint position error and static posturography testing.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of a subjective feeling of dizziness associated with pain, movement, rigidity, or certain positions of the neck at least from 3months; 2) Cervical pain, trauma, and/or disease (3) If from traumatic origin, there has to be a temporal proximity between the onset of dizziness and the neck injury.
排除标准
- •Exclusion of these differential diagnoses: (a) Migrainous vertigo (b) Vertigo of central origin (c) Benign paroxysmal positional vertigo (d) Meniere disease (e) Vestibular neuritis (f) Vertigo induced by drugs (g) Psychogenic vertigo (anxiety and/or panic disorder and/or phobia) (h) Orthostatic hypotension
- •presence of trauma or recent surgery in the head, face, neck, or chest; an otorhinolaryngological diagnosis of central or peripheral vertigo, and receiving physiotherapy or other treatment during the study period.
- •allergy to lidocaine
研究组 & 干预措施
Lidocaine
patients will received lidocaine paravertebral injection
干预措施: 0.5% Lidocaine (Drug)
Sham
patients will received saline solution paravertebral injection
干预措施: Saline Solution (NaCl 0,9%) (Drug)
结局指标
主要结局
Dizziness Handicap Inventory
时间窗: one monthe
Dizziness Handicap Inventory version comprises 25 questions designed to assess a patient's functional (9 questions), emotional (9 questions), and physical (7 questions) limitations on a three-point scale, with higher scores reflecting greater perceived handicap
次要结局
- Neck Disability Index(one month)
- Neck Pain Intensity(one month)
- Tampa Scale for Kinesiophobia(one month)
- Hospital Anxiety and Depression Scale.(one month)
- The 36-item short form survey (SF-36)(one month)
- Cervical range of motion(one month)
- Static posturography testing(one month)
- Cervical relocation test (CRT)(one month)
研究者
Alessandro Micarelli
UNITER ONLUS
Uniter Onlus