The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-06-01

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).

Conditions

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Chronic Migraine, Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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infusion of saline

infusion saline for 4 successive weeks once weekly over 45 min

Group Type EXPERIMENTAL

Lidocaine IV

Intervention Type DRUG

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

lidocaine infusion

infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks

Group Type ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type DRUG

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

Interventions

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Lidocaine IV

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

Intervention Type DRUG

Other Intervention Names

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Saline infusion once weekly for 4 successive weeks

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sahar ah El karadawy, phd

Role: STUDY_DIRECTOR

Medical Research I nstitute

Locations

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Alexandria University,Medical Research Institute

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT

PMID: 25205974 (View on PubMed)

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.

Reference Type RESULT

PMID: 34873540 (View on PubMed)

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.

Reference Type RESULT

PMID: 31870279 (View on PubMed)

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.

Reference Type RESULT

PMID: 34145431 (View on PubMed)

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.

Reference Type RESULT

PMID: 30674285 (View on PubMed)

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.

Reference Type RESULT

PMID: 10772585 (View on PubMed)

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.

Reference Type RESULT

PMID: 22083262 (View on PubMed)

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.

Reference Type RESULT

PMID: 11554951 (View on PubMed)

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.

Reference Type RESULT

PMID: 35295486 (View on PubMed)

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.

Reference Type RESULT

PMID: 34956071 (View on PubMed)

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.

Reference Type RESULT

PMID: 15957691 (View on PubMed)

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.

Reference Type RESULT

PMID: 35609890 (View on PubMed)

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.

Reference Type RESULT

PMID: 16389388 (View on PubMed)

Other Identifiers

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E/C.S/N.T71/2023

Identifier Type: -

Identifier Source: org_study_id

The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

infusion of saline

Lidocaine IV

lidocaine infusion

Lidocaine IV

Interventions

Lidocaine IV

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

Alexandria University

Responsible Party

Principal Investigators

Sahar ah El karadawy, phd

Locations

Alexandria University,Medical Research Institute

Countries

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Other Identifiers

E/C.S/N.T71/2023