The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Alexandria University80 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Migraine, Headache

Interventions

Lidocaine IVDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alexandria University,Medical Research Institute

Alexandria, Egypt

Outcomes

Primary Outcomes

Monthly Migraine Days

Number of Migraine Attacks Per Month More or less than (15) for chronicity

Time frame: 3 Month

Verbal analogue scale for pain

verbal analogue scale for pain from( 0) to( 10) as( 0) no pain( 10) severe pain untolerable

Time frame: 3 month

Secondary Outcomes

Migraine attack duration

Duration of each attack from (4) hours to (72) hours

Time frame: 3 Month

Calcitonin Gene Related Peptide Biomarker.

Measurement of CGRP before and after( 1) month from first infusion treatment

Time frame: 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

Time frame: 3 Month

Migraine Disability Assessment Questionaire

(0) Absent of disability,(270) Extremely severe disability,more than (21) severe disability

Time frame: 3 Month

Data from ClinicalTrials.gov

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