The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- NDI, VAS, SF-36
研究概览
简要总结
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.
详细描述
Subjects diagnosed with subacute (2-6 months post-onset) bilateral cervical/ upper back pain will be recruited in this double-blind control study.
A total of 30 subjects with subacute cervical/upper back pain will be recruited. If patients are qualified as participants and agreed to participate in the study by signing the consent form, they will be randomized into either (A) control group (injection of normal saline injection) or (B) study group (injection of BOTOX). The initial history taking step will include medical history including medication and surgery history, duration of pain, pre-injection neck disability index (NDI) and visual analogue scale (VAS) for pain. VAS score will be collected for 4 weeks before injection to ensure stable VAS, otherwise medical records will be reviewed to ensure stable feature of pain. Short Form (SF) -36 Health Survey will be used to assess functional status, and the Beck Depression Inventory (BDI) will be applied to assess psychological aspect. Physical examination will be performed to determine the most tender cervical/ upper back muscles, and rule out operative condition. A simple swallowing test (3-oz water swallowing test) will be applied for dysphagia screening.
The patients will be maintained with routine, standardized physical therapy, oral medication, and stretch exercise after the injection. NDI, VAS, and SF-36 questionnaire will be re-collected at 1, 2, 3, 4, and 6 months after the injection session.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 y/o or greater,
- •Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,
- •VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,
- •If female or child bearing potential, concurrent use of a reliable method of contraception.
排除标准
- •Known allergy or sensitivity to Botulinum toxin type A.
- •Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- •Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function
- •Pregnancy, breast feeding, or planned pregnancy
- •Acute or operative pathology on cervical MRI
- •History of treatment for gatro-esophageal reflux disease
- •Abnormal finding on 3-oz water swallowing test on the initial screening visit
结局指标
主要结局
NDI, VAS, SF-36
次要结局
未报告次要终点