Comparative evaluation of therapeutic and analgesic effect of combined laser and carbamazepine with carbamazepine alone in patients with trigeminal neuralgia : a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in pain intensity using McGill Pain Questionnaire.
研究概览
简要总结
1. Diagnosis of Trigeminal Neuralgia will be made on basis of clinical findings in line with the IHS Classification ICHD-3.
2. Explanation of the treatment protocol will be given to the patient and informed consent will be taken.
3. Baseline scoring of pain (using VAS) will be done.
1. Laser therapy will be performed at the trigger points, based on previous studies we will use laser and carbamazepine in case groups for treatment of TN.
2. Due to ethical considerations, patients in both groups will be subjected to standard pharmaceutical therapy with 100 mg carbamazepine at the onset of treatment and then another 100 mg after 2 days based on severity of pain in patients. This process will be continued until pain is alleviated taking into account the maximum safe dose of carbamazepine.
3. Low level laser therapy (LLLT) along with pharmaceutical therapy will be performed for the case group. Only pharmaceutical therapy shall be given to the control group.
4. The case group shall receive 9 sessions, 3 days a week. The severity of pain will be recorded prior to laser therapy, immediately after each session of laser therapy and one month after completion of treatment using the VAS. The pain scores will be recorded in McGill Pain Questionnaire, with follow-up at 1, 2 and 3 months.
4. Patients will be divided into 2 groups of cases and controls using block randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients clinically diagnosed with TN according to the IHS Classification ICHD-
- •Both males and females.
- •Patients who have given informed consent for the study.
排除标准
- •Patients not willing to participate in the study.
- •Pregnant females.
- •Patients with abnormal CBC and liver function tests.
结局指标
主要结局
Reduction in pain intensity using McGill Pain Questionnaire.
时间窗: baseline and 3 months
次要结局
- Time taken for 50% pain reduction using VAS(twice weekly for initial 4 weeks , 1 month, 2 months and 3 months)
研究者
Saumya Shukla
Institute of Medical Sciences, Banaras Hindu University
