Comparative Efficacy Of Botulinum Toxin Type A Injection Over Conservative Treatment In Task Specific Dystonia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- FAHN MARSDEN DYSTONIA SCORE for hand improvement
研究概览
简要总结
TITLE
COMPARATIVE EFFICACY OF BOTULINUM TOXIN TYPE A INJECTION OVER CONSERVATIVE TREATMENT IN TASK SPECIFIC DYSTONIA
OBJECTIVE
To assess improvement in fahn marsden dystonia score for hand in patients injected with botulinum toxin type A injection at 1, 4, 12 weeks over oral trihexiphenidyl under ultrasound guidance in task specific dystonia.
RESEARCH HYPOTHESIS
there is improvement in fahn marsden dystonia score in patients receiving botulinum toxin type A injection under ultrasound guidance over oral trihexiphenidyl in task specific dystonia patients at 1, 4, 12 weeks
BACKGROUND OF PRESENT STUDY
task specific dystonia is one common cause of significant comorbidity in world. one common form is writer cramp. these symptoms may later aggravate to involve other activities shaving, grooming etc. slowly handwriting becomes less legible causing poor quality of life .prevalence estimates from 11 to 50 and 101 to 430 per million . 10 to 20 % have significant family history. . Regular highly skilled activities performance trigger this. imbalance in basal ganglia precipitate this. including GABAergic pathways. oral trihexiphenidyl usually is used but has not been shown to have significant improvement alone. dose ranges average 41mg in adults to 24 in children, though have high anticholinergic side effects. . botulinum toxin type A injection has shown standard of care in writer cramp with minimal adverse reactions. mechanism includes acetyl choline transmission inhibition at neuromuscular junction. local muscle weakness is a known complications shown in various studies. Though several placebo controlled trials are present with Botulinum toxin type A injection, we intend to compare benefits of botulinum toxin injection over oral trihexiphenidyl in our study as evidence of such studies are less.
METHODOLOGY
study design/ experiment parallel group, open label randomized controlled trial.
study duration 18 months
study place dept of physical medicine and rehabilitation, IPGMER AND SSKM hospital,. kolkata
study population patients attending OPD of PMR dept, IPGMER fulfilling inclusion and exclusion criteria
sample size total 78 ( 39)
place of study department of PHYSICAL MEDICINE AND REHABILITATION , IPGMER AND SSKM HOSPITAL, KOLKATA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient giving consent 2.FAHN MARSDEN DYSTONIA SCORE more than or equal to 2 3.Symptoms since at least 3 months,
- •Patients with selective writing difficulty, showing improvement with diagnostic intramuscular lignocaine injection.
排除标准
- •1.Allergy to botulinum toxin injection 2.Patients presenting with other forms of task specific dystonia as musicians etc
- •Local injection site infection.
- •Patients presenting with hand deformity or contracture.
- •5.Coagulation disorders,
- •Patients with cognitive deficit
- •Patients injected with botulinum toxin injection in past 3 months.
- •pregnant patients.
结局指标
主要结局
FAHN MARSDEN DYSTONIA SCORE for hand improvement
时间窗: 1, 4 , 12 weeks
次要结局
- not applicable(not applicable)
研究者
Subhajyoti Ghosh
Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata