Interventional Management of Trigeminal Neuralgia
- Conditions
- ASA I and II patients with unilateral trigeminal neuralgia
- Registration Number
- CTRI/2018/01/011494
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
- •Thirty adult patients of either sex diagnosed to have Classical trigeminal neuralgia will be recruited for this study.
- Classic TN will be diagnosed according to the International Classification of Headache Disorders-II (2004) Classical TN of more than six months’ duration Pain rating (during the attack) of at least six on a Visual analogue scale (VAS/NRS) No satisfactory pain relief with medical treatment for more than three months; and/or intolerable side effects using oral medications.
- Patient’s refusal to involve in the study 2.
- History of allergy to drugs used in the procedures 3.
- Coagulopathy 4.
- Morbid obesity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Multi-dimensional outcomes as recommended by IMMPACT (Initiative on methods, measurement, and pain assessment in clinical trials) Immediate post operative period | Day 7 | Then every month till 1 year The following domains were assessed Immediate post operative period | Day 7 | Then every month till 1 year Pain: by 11point (0-10) NRS Immediate post operative period | Day 7 | Then every month till 1 year Emotional functioning: by Beck Depression Inventory Immediate post operative period | Day 7 | Then every month till 1 year Global improvement: by Patient Global Impression of change Immediate post operative period | Day 7 | Then every month till 1 year Physical functioning: by Brief Pain Inventory-Facial scale Immediate post operative period | Day 7 | Then every month till 1 year
- Secondary Outcome Measures
Name Time Method Health related quality of life would be measured by EQ-5D-3L (paper version) questionnaire Spontaneous reporting of symptoms and adverse events with open ended prompts with each visit
Trial Locations
- Locations (1)
AIIMS New Delhi
🇮🇳South, DELHI, India
AIIMS New Delhi🇮🇳South, DELHI, IndiaDr Virender Kumar MohanPrincipal investigator9868397803dr_vkmohan@yahoo.com