Interventional Management of Trigeminal Neuralgia
Not Applicable
- Conditions
- Health Condition 1: null- ASA I and II patients with unilateral trigeminal neuralgia
- Registration Number
- CTRI/2018/01/011494
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•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 monthsâ?? 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
Exclusion Criteria
1. Patientâ??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) <br/ ><br> <br/ ><br>The following domains were assessed <br/ ><br> <br/ ><br>Pain: by 11point (0-10) NRS <br/ ><br> <br/ ><br>Physical functioning: by Brief Pain Inventory-Facial scale <br/ ><br> <br/ ><br>Emotional functioning: by Beck Depression Inventory <br/ ><br> <br/ ><br>Global improvement: by Patient Global Impression of change <br/ ><br>Timepoint: Immediate post operative period <br/ ><br> <br/ ><br>Day 7 <br/ ><br> <br/ ><br>Then every month till 1 year <br/ ><br>
- Secondary Outcome Measures
Name Time Method Health related quality of life would be measured by EQ-5D-3L (paper version) questionnaire <br/ ><br> <br/ ><br>Spontaneous reporting of symptoms and adverse events with open ended prompts with each visit <br/ ><br> <br/ ><br>Complications to be noted: <br/ ><br>Residual Pain <br/ ><br>Dysaesthesia <br/ ><br>Decreased corneal sensation <br/ ><br>Masseter weakness <br/ ><br>Diplopia and <br/ ><br>Procedure related complications:Timepoint: Immediate post op <br/ ><br> <br/ ><br>at day 7 <br/ ><br> <br/ ><br>then <br/ ><br> <br/ ><br>every month for 1 year