Clinical trial NCT06109389: The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache
Official title: The Efficacy of Intravenous Lidocaine Infusion in Chronic Unilateral Migraine Headache Clinical and Laboratory Assessment .Aprospective Randomized Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Migraine, Headache
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Monthly Migraine Days
timeFrame: 3 Month
measure: Verbal analogue scale for pain
timeFrame: 3 month
Secondary outcomes:
measure: Migraine attack duration
timeFrame: 3 Month
measure: Calcitonin Gene Related Peptide Biomarker.
timeFrame: 3 Month
measure: Migraine Specific Quality Of Life Questionaire
timeFrame: 3 Month
measure: Migraine Disability Assessment Questionaire
timeFrame: 3 Month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University,Medical Research Institute
Study officials:
affiliation: Medical Research I nstitute
name: Sahar ah El karadawy, phd
role: STUDY_DIRECTOR
References:
citation: Aggarwal M, Puri V, Puri S. Serotonin and CGRP in migraine. Ann Neurosci. 2012 Apr;19(2):88-94. doi: 10.5214/ans.0972.7531.12190210.
citation: Al Ghadeer HA, AlSalman SA, Albaqshi FM, Alsuliman SR, Alsowailem FA, Albusror HA, AlAbdi ZI, Alwabari EM, Alturaifi ZA, AlHajji AM. Quality of Life and Disability Among Migraine Patients: A Single-Center Study in AlAhsa, Saudi Arabia. Cureus. 2021 Nov 2;13(11):e19210. doi: 10.7759/cureus.19210. eCollection 2021 Nov.
citation: Andreou AP, Edvinsson L. Mechanisms of migraine as a chronic evolutive condition. J Headache Pain. 2019 Dec 23;20(1):117. doi: 10.1186/s10194-019-1066-0.
citation: Eigenbrodt AK, Ashina H, Khan S, Diener HC, Mitsikostas DD, Sinclair AJ, Pozo-Rosich P, Martelletti P, Ducros A, Lanteri-Minet M, Braschinsky M, Del Rio MS, Daniel O, Ozge A, Mammadbayli A, Arons M, Skorobogatykh K, Romanenko V, Terwindt GM, Paemeleire K, Sacco S, Reuter U, Lampl C, Schytz HW, Katsarava Z, Steiner TJ, Ashina M. Diagnosis and management of migraine in ten steps. Nat Rev Neurol. 2021 Aug;17(8):501-514. doi: 10.1038/s41582-021-00509-5. Epub 2021 Jun 18.
citation: Di Tanna GL, Porter JK, Lipton RB, Brennan A, Palmer S, Hatswell AJ, Sapra S, Villa G. Migraine day frequency in migraine prevention: longitudinal modelling approaches. BMC Med Res Methodol. 2019 Jan 23;19(1):20. doi: 10.1186/s12874-019-0664-5.
citation: Hand PJ, Stark RJ. Intravenous lignocaine infusions for severe chronic daily headache. Med J Aust. 2000 Feb 21;172(4):157-9. doi: 10.5694/j.1326-5377.2000.tb125538.x.
citation: Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012 Feb;16(1):86-92. doi: 10.1007/s11916-011-0233-z.
citation: Lipton RB, Diamond S, Reed M, Diamond ML, Stewart WF. Migraine diagnosis and treatment: results from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):638-45. doi: 10.1046/j.1526-4610.2001.041007638.x.
citation: Mungoven TJ, Henderson LA, Meylakh N. Chronic Migraine Pathophysiology and Treatment: A Review of Current Perspectives. Front Pain Res (Lausanne). 2021 Aug 25;2:705276. doi: 10.3389/fpain.2021.705276. eCollection 2021.
citation: Schoenen J, Timmermans G, Nonis R, Manise M, Fumal A, Gerard P. Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes. Front Neurol. 2021 Dec 10;12:805334. doi: 10.3389/fneur.2021.805334. eCollection 2021.
citation: Myles PS, Urquhart N. The linearity of the visual analogue scale in patients with severe acute pain. Anaesth Intensive Care. 2005 Feb;33(1):54-8. doi: 10.1177/0310057X0503300108.
citation: Schwenk ES, Walter A, Torjman MC, Mukhtar S, Patel HT, Nardone B, Sun G, Thota B, Lauritsen CG, Silberstein SD. Lidocaine infusions for refractory chronic migraine: a retrospective analysis. Reg Anesth Pain Med. 2022 Jul;47(7):408-413. doi: 10.1136/rapm-2021-103180.
citation: Fink R. Pain assessment: the cornerstone to optimal pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):236-9. doi: 10.1080/08998280.2000.11927681.