Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic Cervical Myofascial Pain Syndrome?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Concentration of anti-inflammatory markers
研究概览
简要总结
The aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine. The mesotherapy procedure will be performed five times, at weekly intervals. Blood will be collected before the start of mesotherapy, a week after its completion and after 3 months of follow-up. In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed.
详细描述
Study aim:
The main objective of this article was to answer the question: Can biomarkers of inflammatory processes in the blood and BDNF be used to evaluate the effectiveness of collagen mesotherapy in chronic CMPS? The second objective of this article is to evaluate the safety of collagen mesotherapy in chronic CMPS.
Material and methods:
The study was conducted on patients aged 18 to 80 years, of both sexes, with local, chronic cervical spine pain syndrome, without radiation of symptoms to the upper limb. The study subjects were recruited at the National Institute of Geriatric, Rheumatology and Rehabilitation in Warsaw. Patients will be recruited according to the inclusion and exclusion criteria. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine.
Each patient will have blood collected before starting mesotherapy (on the same day) to determine anti-inflammatory markers (TNF-alpha, interleukin-1-beta, interleukin-6) and BDNF. Again, a week after the end of mesotherapy (five treatments) and after 6-week of follow-up, blood will be collected to determine the same markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with chronic (>12 weeks) cervical spine pain syndrome of muscular, myofascial nature without radiation to the upper limb
- •recent MRI or CT scan of the cervical spine (up to 6 months)
- •no serious diseases: cancer, rheumatology, metabolic
- •no allergy to lignocaine 1% or injectable type I collagen
排除标准
- •another cause of cervical spine pain
- •lack of patient consent
研究组 & 干预措施
Injection type I collagen
Injection 1% lignocaine
结局指标
主要结局
Concentration of anti-inflammatory markers
时间窗: Blood collection before starting the mesotherapy treatment (on the same day), one week after its completion (after 5 weeks from start), and after 6 weeks from end
Blood collection before starting the mesotherapy treatment (on the same day), one week after its completion, and after 6 weeks follow-up
次要结局
未报告次要终点