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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infusion of saline | Experimental | infusion saline for 4 successive weeks once weekly over 45 min |
|
| lidocaine infusion | Active Comparator | infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine IV | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Excusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sahar ah El karadawy, phd | Medical Research I nstitute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University,Medical Research Institute | Alexandria | 5310002 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25205974 | Result | 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. | |
| 34873540 | Result | 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. |
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all data and results will be available to share of other researches after completion
6 to 9 month
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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 |
| 31870279 | Result | 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. |
| 34145431 | Result | 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. |
| 30674285 | Result | 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. |
| 10772585 | Result | 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. |
| 22083262 | Result | 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. |
| 11554951 | Result | 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. |
| 35295486 | Result | 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. |
| 34956071 | Result | 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. |
| 15957691 | Result | 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. |
| 35609890 | Result | 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. |
| 16389388 | Result | 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. |