Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard therapy. The patients are randomised into two groups: standard therapy group and standard therapy plus Neuromultivit group.
详细描述
Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days.
Group 2 (50 patients) receive only standard therapy for 20 days.
Standard therapy involves:
- Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days
- Sirdalud (2 mg tablets three times a day) for 20 days
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
- None
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
- •diagnosed vertebrogenic radiculopathy L5, S1
- •radicular pain syndrome
- •changes in the low back CT and MRI scans
- •minimum 40 mm intensity of spontaneous back pain, rated on the VA scale
- •1 month exacerbation phase; nonuse of any B-group vitamins before the trial
- •negative urine pregnancy test; Patient Informed Consent
排除标准
- •tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy
- •concomitant life-threatening medical conditions
- •simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases
- •epilepsy, alcohol and drug addiction
- •pregnancy and breast-feeding
- •any condition preventing CT and MRI tests, including obesity and special devices
- •participation in any other clinical study 1 month before enrollment.
研究组 & 干预措施
Neuromultivit +Voltaren+Sirdalud
Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days.
Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days.
干预措施: Neuromultivit (Drug)
Neuromultivit +Voltaren+Sirdalud
Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days.
Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days.
干预措施: Voltaren (Drug)
Neuromultivit +Voltaren+Sirdalud
Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days.
Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days.
干预措施: Sirdalud (Drug)
Voltaren+Sirdalud alone
Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days
干预措施: Voltaren (Drug)
Voltaren+Sirdalud alone
Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days
干预措施: Sirdalud (Drug)
结局指标
主要结局
Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale
时间窗: baseline and 3 weeks
Self reported pain intensity over the last 24 hours. The amount of pain is marked on a horizontal line at a certain point which reflects pain perception best: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
次要结局
- Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire(baseline and 3 weeks)
- Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale(baseline and 3 weeks)
- Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale(baseline and 3 weeks)