Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- extent of pain.
研究概览
简要总结
The objective of this Interventional case-control clinical study is to evaluate the effectiveness of physiotherapy combined with the administration of Alpha Lipoic Acid, L-acetylcarnitine, Resvelatrol, Vit D3 in the treatment of sciatica due to herniated disc in young patients.
The main questions we intend to answer are:
- Is this combined treatment more effective in reducing pain?
- Is the combined treatment useful for improving postural alterations, reducing the intake of painkillers and the number of days of absence from work and improving the quality of life?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-45 years
- •pain with NRS scale score between 5 and 7 points
- •symptoms attributable to lumbosciatica which occurred no more than 4 weeks ago
- •pharmacological wash out of NSAIDs and corticosteroids for at least a week
- •presence of L4-L5, L5-S1 disc herniation diagnosed with lumbar MRI performed within 3 months
- •absence of ongoing infectious episodes;
- •written consent for participation in the study.
排除标准
- •Altered states of consciousness;
- •Sciatica not of disc origin
- •Neurological disorders
- •Presence of scoliosis >20° of Cobb
- •Previous spinal surgery
- •Pregnancy and/or breastfeeding
研究组 & 干预措施
Treatment Group
Treatment Group was composed of patients who will undergo daily pharmacological therapy with Alpha Lipoic Acid 600 mg, L-acetylcarnitine 1000 mg, Resvelatrol 50 mg, Vit D3 800UI for 30 consecutive days in combination with a rehabilitation protocol lasting 20 sessions
干预措施: supplementation (Other)
Treatment Group
Treatment Group was composed of patients who will undergo daily pharmacological therapy with Alpha Lipoic Acid 600 mg, L-acetylcarnitine 1000 mg, Resvelatrol 50 mg, Vit D3 800UI for 30 consecutive days in combination with a rehabilitation protocol lasting 20 sessions
干预措施: rehabilitation (Other)
Control Group
Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions.
干预措施: rehabilitation (Other)
结局指标
主要结局
extent of pain.
时间窗: at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2)
Numeric Rating Scale (0-10)
次要结局
- degree of disability of low back pain(at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2))
- quality of life in relation to low back pain(at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2))
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo