The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Study Overview
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Brief Summary
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STUDY THE EFFICACY OF INTRAVENOUS LIDOCAINE INFUSION ON PATIENTS WITH CHRONICUNILATERAL MIGRAINE HEADACHE ..NO OF PATIENTS 80..WILLBE DIVIDED INTO 2 GROUPS..FIRST WILL RECEIVE MEDICAL TREATMENT PLUS LIDOCAINE INFUSION ONCE WEEKLY FOR 4 SUCCESIVE WEEKS ,OTHER WILL RECEIVE MEDICAL TREATMENT PLUS SALINE INFUSION SAME REGIMNE,FOLLOW UP USING MONTHLY MIGRAINE DAYS,VAS SCORE,MIDAS SCORE,QUALITY OF LIFE QUESTIONAIRE,PRE AND POST MEASUREMENT OF CALCITONIN GENE RELATED PEPTIDE

Detailed Description
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Group A will receive medical treatment for migraine plus normal saline infusion,Group B will receive medical treatment plus lidocaine infusion at dose from 3 to 4 mg per kg,computer generated random number will be used to identify the selected blocks and give the sequence of patients allocation,guarantee equal random in each group a set of permuted blocks will be generated. Each block has 4 differently ordered treatment assignments.Block 1 (AABB),Block2(ABAB),Block3(BABA),Block 4(ABBA),Block5(BAAB),Block 6(BBAA).

Official Title
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The Efficacy of Intravenous Lidocaine Infusion in Chronic Unilateral Migraine Headache Clinical and Laboratory Assessment .Aprospective Randomized Double Blind Controlled Study

Conditions
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Chronic Migraine, Headache

Intervention / Treatment
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* Drug: Lidocaine IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (18-55) years for both genders. Patients with chronic unilateral migraine headache for at least (3) month with VASscore more than (4). Patient who failed to respond to conservative treatment as medical treatment algorithm including at least tow preventive trials. Excusion criteria: patient with disabling chronic disease or psychiatric illness unstable cardiac arrhythmia patient refusal red flags

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infusion of saline<br>infusion saline for 4 successive weeks once weekly over 45 min | Drug: Lidocaine IV<br>* LIDOCAINE INFUSION STARTED 3 MG PER KG FOR 2 SUCCESSIVE WEEKS ,THEN 4 MG PER KG FOR ANOTHER 2 WEEKS .ONCE WEEKLY,other group saline infusion once weekly for 4 successive weeks<br>* Other names: Saline infusion once weekly for 4 successive weeks;|
| Active Comparator: lidocaine infusion<br>infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks | Drug: Lidocaine IV<br>* LIDOCAINE INFUSION STARTED 3 MG PER KG FOR 2 SUCCESSIVE WEEKS ,THEN 4 MG PER KG FOR ANOTHER 2 WEEKS .ONCE WEEKLY,other group saline infusion once weekly for 4 successive weeks<br>* Other names: Saline infusion once weekly for 4 successive weeks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly Migraine Days | Number of Migraine Attacks Per Month More or less than (15) for chronicity | 3 Month | 
| Verbal analogue scale for pain | verbal analogue scale for pain from( 0) to( 10) as( 0) no pain( 10) severe pain untolerable | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine attack duration | Duration of each attack from (4) hours to (72) hours | 3 Month | 
| Calcitonin Gene Related Peptide Biomarker. | Measurement of CGRP before and after( 1) month from first infusion treatment | 3 Month | 
| Migraine Specific Quality Of Life Questionaire | 14 questions ,each one measured from ( 1) never affect to(6) always affect ,answers summed for all questions value is obtained | 3 Month | 
| Migraine Disability Assessment Questionaire | (0) Absent of disability,(270) Extremely severe disability,more than (21) severe disability | 3 Month |