Intradermal Mesotherapy Versus Systemic Therapy in Treating Neck Pain to Cervical Disc Herniation: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
Introduction: Neck pain is a global public health concern, that ranked 4th highest health condition in terms of disability as measured by years lived with disability. The aim of this study is to compare the efficiency of one-session mesotherapy application with systemic therapy in treating neck pain related to cervical disk herniation.
Methods: This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation. A mixture of thiocolchicoside, lidocaine and tenoxicamwas administered via mesotherapy in one group, and intravenous administration of dexketoprofen was applied to the other group. We compared the changes in pain intensity at 60thminute, 120thminute and 24th hours after treatment using Visual Analogue Scale (VAS),and adverse effects of the treatment methods among the study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older age
- •Admission to Emergency Department (ED) with acute cervical pain related to cervical disk herniation.
排除标准
- •Taking analgesic drugs before admission
- •Having VAS score of lower than 4 on admission
- •Having diabetes mellitus
- •Body mass index>30 kg/m2
- •Pregnancy
- •Lactation
- •Having active bleeding or bleeding disorder
- •Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions
- •Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).
结局指标
主要结局
Change in pain intensity
时间窗: 0-24 hours
we defined as the delta value of Vizuel Analog Score(points between 0-10,the most severe pain 10 points,0 points no pain) scores with different time intervals. We calculated delta values by subtracting the VAS scores at 60th and 120th minutes, and 24th hours from the VAS score on admission.
Adverse effect
时间窗: 0-1 week
we have defined as the presence of hypotension, dizziness, nausea, vomiting, diarrhea, edema, localized infections, pruritus, bruising or swelling at the injection sites in the mesotherapy group; and presence of dry mouth, hypotension, dizziness, nausea, vomiting, diarrhea, dyspepsia, peptic ulceration, peptic ulcer bleeding, urticarial lesion, pruritus in the systemic therapy group. The patients were followed up for one week for presence of adverse effects. We interviewed with the patientsdaily by telephone for adverse effects, and evaluated all the patientswith an ED visit at the end of follow-up period.
次要结局
未报告次要终点
研究者
Abdullah Osman KOCAK
Principal Investigator
Ataturk University