The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Median nerve conduction velocity
研究概览
简要总结
The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.
The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.
Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization, patients will be placed into one of two groups:
Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.
Group B: surgical decompression of the median nerve followed by treatment with placebo
The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.
详细描述
The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function, often also because of a prolonged illness prior to the decompression, causing extensive damage to the nerve, including demyelination, or other morphofunctional deficits. For this reason it could be particularly useful to associate a dietary supplement as a support to the structure and physiology of nerve in the post-decompression period. In this respect, the alpha-lipoic acid molecule seems to be a particularly interesting. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.
The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.
Patients will be enrolled with proven carpal tunnel syndrome, confirmed by a careful examination including the diagnostic maneuvers Phalen, Tinel and antiPhalen. By means of randomization, patients will be placed into one of two groups:
Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.
Group B: surgical decompression of the median nerve followed by treatment with placebo Surgical treatment is performed in both groups according to the standard for this type of intervention, and within 90 days after joining the waiting list.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from primary carpal tunnel syndrome, confirmed clinically and with nerve conduction studies
排除标准
- •Recurrent or secondary carpal tunnel syndromes.
- •Diabetic patients.
- •Patients with pace-makers.
结局指标
主要结局
Change in Median nerve conduction velocity
时间窗: Preoperatively and 90 days after median nerve decompression
次要结局
- Score with Boston questionnaire on carpal tunnel syndrome(Preoperatively and 90 days postdecompression)
- Two point discrimination test on index finger pulp(Preoperatively and 90 days postdecompression)