跳至主要内容
临床试验/CTRI/2025/03/082450
CTRI/2025/03/082450招募中不适用

A comprehensive prospective study on trigeminal neuralgia (TN) and atypical facial pain (AFP) to evaluate surgical and non-surgical management strategies.

Amrita Institute of Medical Sciences and Research Centre1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2025年5月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
164
试验地点
1
主要终点
pain relief as assessed by visual analog scale (VAS), Neuropathy Sensory Symptom Scale and Neuropathy Total Symptom Score-6 scale.

研究概览

简要总结

The prospective design with standardised and systematic assessments of the patients and the set up as a real-life study is a major strength of this study. Real world data is difficult to acquire but does offer a more realistic view of the situation. This single centre prospective study will be further developed in to multicentric registry which will be aid for any trigeminal neuralgia and atypical facial pain based clinical research and 5 randomised controlled clinical trials in the future. Studies shows that, group of medically managed patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50% reduction of the overall burden of pain over a two-year period. Continuous advice, education, and support from the multidisciplinary team, along with referral of medically intractable patients for surgery, play crucial roles in managing the natural history of the disease. The favourable prognosis offers hope and optimism for both patients and care providers, indicating that specialist management of the mentioned diseases will be highly rewarding.

This prospective cohort study will be conducted at the Department of neurology and neurosurgery at Amrita hospital. It will include all trigeminal neuralgia and atypical facial pain patients who express their interest to participate in the study by signing the informed consent document. Data collected will encompass demographic and clinical information obtained directly from patient interviews. This data will be recorded directly in the EDC system METAFLO. The entered data will be verified and validated by the PI or the PI’s designee according to the data management plan. The cleaned data will then be statistically analysed and utilized for publications.

The study will be conducted prospectively for 2 years with follow-up at 3, 6, and 12 months.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients who have history and clinical presentation consistent with IHS (International Headache Society criteria ICHD-3 beta for trigeminal neuralgia (TN) and non- TN atypical facial pain who visit the department of neurology and neurosurgery at Amrita hospital.
  • Patients above 18 years who are willing to sign the informed consent form.

排除标准

  • Patients who are not interested to participate in the study.
  • Patients below 18 years.

结局指标

主要结局

pain relief as assessed by visual analog scale (VAS), Neuropathy Sensory Symptom Scale and Neuropathy Total Symptom Score-6 scale.

时间窗: baseline visit and at months 3, 6, 12 and 24

次要结局

  • Quality of Life factors using short form questionnaire (SF12)(3, 6, 12 months)

研究者

发起方
Amrita Institute of Medical Sciences and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ashok Pillai

Amrita Institute of medical sciences and research centre

研究点 (1)

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