Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of trigger points
研究概览
简要总结
Several studies have previously examined the use of botulinum toxin serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:
- inclusion of confounding conditions in the proband group, and
- inability to identify predictors of response.
This study attempts to define the characteristics of responders to botulinum serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome).
详细描述
Design: Single-center, double-blind, placebo-controlled, enriched trial.
Subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline visit. At baseline, patients with a Numerical Pain Rating of 4 or greater will be injected with Botulinum Toxin Serotype A. At 14 weeks postinjection, those who at the 6 weeks post-injection visit had at least a 50% decrease in their pain outcome measures will be randomized into one of two treatment groups. Group 1 will receive a second BTX injection while group 2 will receive an injection of saline and both groups will be followed for an additional 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •Male or female patients aged 18-65 years.
- •Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks
- •Patients have numerical pain rating of 4 or greater
- •Patients willing to adhere to a physical therapy program of 2-3 visits for myofascial release and also home stretching exercises for the length of the study
- •Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study.
- •Women of child-bearing potential must be using a reliable means of contraception and have a negative urine pregnancy test prior to injection of BOTOX.
排除标准
- •Subjects currently taking schedule II narcotics
- •No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study
- •Pregnant or breastfeeding women
- •Use of investigational drugs within one month of study
- •Involvement in litigation surrounding neck pain
- •Significant medical or psychiatric disease
- •Patients with clinical depression (Beck's Depression score)
- •Alcohol or drug abuse, in the opinion of the investigator
结局指标
主要结局
Number of trigger points
Numerical pain rating
Neck Disability Index
Cervical range of motion
Postural exam
Brief Pain Inventory
次要结局
- Short Form (SF)-36
- Pain Diary and medications use
研究者
F. Michael Ferrante
Principal Investigator
University of California, Los Angeles