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临床试验/CTRI/2024/06/068319
CTRI/2024/06/068319尚未招募不适用

Comparative evaluation of therapeutic and analgesic effect of combined laser and carbamazepine with carbamazepine alone in patients with trigeminal neuralgia : a randomised controlled trial

Saumya Shukla1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月15日最近更新:

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

发起方
Saumya Shukla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Saumya Shukla

Institute of Medical Sciences, Banaras Hindu University

研究点 (1)

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