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Migraine Disability Assessment (migraine + disability_assessment)
Selected AbstractsA Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Validity and Reliability of the Turkish Migraine Disability Assessment (MIDAS) QuestionnaireHEADACHE, Issue 8 2004Mustafa Erta Objectives.,The aim of this study is to assess the comprehensibility, internal consistency, patient-physician reliability, test-retest reliability, and validity of Turkish version of Migraine Disability Assessment (MIDAS) questionnaire in patients with headache. Background.,MIDAS questionnaire has been developed by Stewart et al and shown to be reliable and valid to determine the degree of disability caused by migraine. Design and Methods.,This study was designed as a national multicenter study to demonstrate the reliability and validity of Turkish version of MIDAS questionnaire. Patients applying to 17 Neurology Clinics in Turkey were evaluated at the baseline (visit 1), week 4 (visit 2), and week 12 (visit 3) visits in terms of disease severity and comprehensibility, internal consistency, test-retest reliability, and validity of MIDAS. Since the severity of the disease has been found to change significantly at visit 2 compared to visit 1, test-retest reliability was assessed using the MIDAS scores of a subgroup of patients whose disease severity remained unchanged (up to ±3 days difference in the number of days with headache between visits 1 and 2). Results.,A total of 306 patients (86.2% female, mean age: 35.0 ± 9.8 years) were enrolled into the study. A total of 65.7%, 77.5%, 82.0% of patients reported that "they had fully understood the MIDAS questionnaire" in visits 1, 2, and 3, respectively. A highly positive correlation was found between physician and patient and the applied total MIDAS scores in all three visits (Spearman correlation coefficients were R= 0.87, 0.83, and 0.90, respectively, P < .001). Internal consistency of MIDAS was assessed using Cronbach's , and was found at acceptable (>0.7) or excellent (>0.8) levels in both patient and physician applied MIDAS scores, respectively. Total MIDAS score showed good test-retest reliability (R= 0.68). Both the number of days with headache and the total MIDAS scores were positively correlated at all visits with correlation coefficients between 0.47 and 0.63. There was also a moderate degree of correlation (R= 0.54) between the total MIDAS score at week 12 and the number of days with headache at visit 2 + visit 3, which quantify headache-related disability over a 3-month period similar to MIDAS questionnaire. Conclusion.,These findings demonstrated that the Turkish translation is equivalent to the English version of MIDAS in terms of internal consistency, test-retest reliability, and validity. Physicians can reliably use the Turkish translation of the MIDAS questionnaire in defining the severity of illness and its treatment strategy when applied as a self-administered report by migraine patients themselves. [source] Use of the Migraine Disability Assessment Questionnaire in Children and Adolescents With Headache: An Italian Pilot StudyHEADACHE, Issue 7 2003D. D'Amico MD Objectives.,To determine the suitability of the Migraine Disability Assessment (MIDAS) Questionnaire for assessing disability in children and adolescents with headache and to obtain preliminary information about disability in different primary headaches. Background.,During the last decade, researchers have begun to employ standardized methodologies to investigate the global impact of primary headaches. Disease-specific instruments have been developed to measure headache-related disability. The MIDAS Questionnaire, which is the most extensively studied of these instruments, was designed to assess the overall impact of headaches over the 3 months before compilation. The MIDAS Questionnaire is an optimal tool to assess headache-related disability in adults. Methods.,Ninety-five patients aged 7 to 17 years with tension-type headache, migraine, or both completed the validated Italian form of the MIDAS questionnaire on 2 occasions. Test-retest reliability was assessed by the Spearman rank correlation test. The Cronbach , assessed internal consistency. The patients answered questions about the adequacy of the questionnaire. Results.,The Cronbach , was .8. Correlation coefficients were generally high for the overall MIDAS score and for the items investigating disability in school and in family/leisure activities; they were lower for the items about housework. Most patients thought that the MIDAS Questionnaire was useful (98.9%) and that it captured the impact of their headaches (58.9%); 41% thought that questions about disability in housework were useless, 44.2% suggested adding questions regarding inability to do homework. All primary headaches had a considerable impact on daily activities, but patients with migraine tended to have lower headache frequencies and lower total disability time; those with tension-type headache suffered more days in which activities, although performed, were substantially impaired. Conclusions.,The MIDAS Questionnaire is useful for assessing disability in children and adolescents with different primary headaches. Minimal changes in the phrasing and content of the items would be sufficient to render the MIDAS specific for the younger population with headache. [source] Peripheral Neurostimulation for the Treatment of Chronic, Disabling Transformed MigraineHEADACHE, Issue 4 2003Charles A. Popeney DO Background.,Up to 5% of the general population suffers from transformed migraine. This study analyzes clinical responses of transformed migraine to cervical peripheral nerve stimulation. Methods.,Headache frequency, severity, and disability (Migraine Disability Assessment [MIDAS] scores) were independently measured in an uncontrolled consecutive case series of 25 patients with transformed migraine implanted with C1 through C3 peripheral nerve stimulation. All patients met International Headache Society (IHS) criteria for episodic migraine, as well as suggested criteria for transformed migraine, and had been refractory to conventional treatment for at least 6 months. Responses to C1 through C3 peripheral nerve stimulation were recorded. Results.,Prior to stimulation, all patients experienced severe disability (grade IV on the MIDAS) with 75.56 headache days (average severity, 9.32; average MIDAS score, 121) over a 3-month period. Following stimulation, 15 patients reported little or no disability (grade I), 1 reported mild disability (grade II), 4 reported moderate disability (grade III), and 5 continued with severe disability (grade IV), with 37.45 headache days (average severity, 5.72; average MIDAS score, 15). The average improvement in the MIDAS score was 88.7%, with all patients reporting their headaches well controlled after stimulation. Conclusions.,These results raise the possibility that C1 through C3 peripheral nerve stimulation can help improve transformed migraine symptoms and disability. A controlled study is required to confirm these results. [source] Subcutaneous histamine versus sodium valproate in migraine prophylaxis: a randomized, controlled, double-blind studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 10 2007R. O. Millán-Guerrero Histamine has a selective affinity for H3-receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology. The objective of this study was to evaluate the therapeutic potential of subcutaneous administration of histamine in migraine prophylaxis, compared with oral administration of sodium valproate, in an open clinical trial. Ninety-two patients with migraine were selected under criteria established by the International Headache Society and enrolled in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1,10 ng twice a week; n = 46) compared with oral administration of sodium valproate (500 mg daily dose; n = 46). The variables studied were headache intensity, frequency, duration, analgesic intake and migraine disability assessment (MIDAS). Two-tailed Student's t - test was used to compare means and the Mann,Whitney U and anova tests were used. The data collected during the 4th, 8th and 12th weeks of treatment revealed that histamine caused a significantly greater reduction (P < 0.001) in intensity and duration of migraine attacks as well as in analgesic intake. No difference was detected in the frequency of attacks or in MIDAS. The present study provides evidence of the superior efficacy of histamine applied subcutaneously in migraine prophylaxis when compared with sodium valproate taken orally. Subcutaneously applied histamine may represent a novel and effective therapeutic alternative in resistant migraine patients. [source] Scanning laser polarimetry with variable corneal compensation in migraine patientsACTA OPHTHALMOLOGICA, Issue 7 2009Antonio Martinez Abstract. Purpose:, This study aimed to compare scanning laser polarimetry measurements of retinal nerve fibre layer (RNFL) thickness in eyes of migraine patients with those in eyes of age-matched, healthy subjects. Methods:, The study was designed as an observational, prospective, cross-sectional study. It included 57 eyes of 57 patients with migraine with or without aura according to the criteria of the International Headache Society and 44 eyes of 44 age-matched healthy controls. Scanning laser polarimetry images were obtained using a commercial GDx VCC system (Version 5.3.1; Laser Diagnostic Technologies, Inc.). At each sitting, three sets of GDx VCC measurements were acquired for each patient and used in the analysis. Image acquisition was performed in undilated eyes in all subjects. Results:, The mean ± standard deviation RNFL average thickness parameter in the migraine subjects was significantly lower than in the control group, at 50.4 ± 4.8 ,m versus 54.7 ± 3.4 ,m, respectively (p < 0.0001). However, there were no differences between migraine subjects and controls in mean RNFL thickness in superior and inferior areas. In the migraine group the mean migraine disability assessment (MIDAS) score was 34.3 ± 15.3 and the mean number of attacks per year was 17.1 ± 6.9 (range 6,28). The mean RNFL average thickness parameter was significantly correlated with MIDAS score (r = , 0.86, p < 0.0001) and frequency of attacks (r = , 0.86, p < 0.0001). Conclusions:, The mean RNFL average thickness parameter was found to be thinner in migraine patients. In addition, we found a strong correlation between migraine severity and RNFL average thickness parameters. [source] | ||||||||||