Shaun G. Kilminster

Disability associated with headaches occurring inside and outside the menstrual period in those with migraine: a general practice study.

Objectives.—This study investigated the disability of females who have migraine and other headache attacks occurring during and outside the menstrual period.

Patient Preference for Triptan Formulations: A Prospective Study With Zolmitriptan

Objectives.—To investigate patterns of patient preference for 3 formulations of zolmitriptan, in a primary care study utilizing a naturalistic longitudinal design.

Clinical Profile of Botulinum Toxin A in Patients with Chronic Headaches and Cervical Dystonia

AbstractBackground and objectives: Some evidence for the efficacy of botulinum toxin A as a preventive treatment for chronic primary headaches has been reported in randomized, controlled clinical studies. This study investigated the clinical profile of botulinum toxin A in a naturalistic clinical practice setting in a population of patients with cervical dystonia associated with chronic headache and a history of migraine. Methods: This was a prospective, open-label, longitudinal study. Following a prospective run-in period, eligible patients were given three sets of botulinum toxin A injections at 8- to 12-week intervals over a 16- to 24-week period and were monitored for 3 months after the final injections. Efficacy was assessed in terms of headache-related disability (using the Migraine Disability Assessment [MIDAS] questionnaire), pain and emotional function (using the Short Pain Inventory [SPI©]), quality of life (QOL, using the Short-Form-36 [SF-36] questionnaire) and patient-assessed headache frequency and severity, and medication use and its effectiveness. Safety was assessed as adverse events. The primary endpoint was the change in MIDAS score from baseline following treatment with botulinum toxin A. Results: Twenty-four patients took part in the study and 17 (71%) completed the study. There were significant improvements in headache-related disability (MIDAS score), pain and emotional function (SPI©), QOL (SF-36), headache frequency and medication use following treatment with botulinum toxin A (p < 0.05 for all endpoints). An efficacy response occurred within 8 weeks of treatment initiation and was maintained throughout the study duration. Botulinum toxin A was generally well tolerated. Conclusions: This study demonstrated that botulinum toxin A is an effective and well tolerated preventive treatment for chronic headache in patients with cervical dystonia and a history of migraine. These results warrant further investigation in a large, randomized, controlled study.

COMPARISON OF DICLOFENAC SPRAY AND GEL ON KNEE JOINTS OF PATIENTS WITH OSTEOARTHRITIC PAIN

AbstractObjective: To compare a new diclofenac spray with the reference gel preparation in patients with osteoarthritic knee pain. Design: Patients were monitored for at least 1 week for consistent pain. They then underwent 1 week of active treatment, a 1-week washout and then crossed over onto the alternative treatment in a counterbalanced trial. Setting: Patients were screened and reviewed on a hospital outpatient basis. Treatments and pain measures were administered at home. Patients: Forty-three patients with osteoarthritic knee pain were randomised and 39 completed both treatments. At entry (n = 43), the mean (±SD) age was 58.6 ±12.8 years and the mean bodyweight was 76.7 ±17.1kg. Interventions: Patients applied 17.5 to 35mg of diclofenac from a metered dose (3.5mg) spray or 20 to 40mg of diclofenac as a 1% gel, three times daily. Outcome Measures: Pain was measured daily on a simple 5-point Likert scale and recorded in a study diary card. Global pain was assessed with the Short Pain Inventory© (SPI) on days 4 and 7 of each treatment. Results: Pain ratings by diary card and the SPI showed significantly improved analgesia and pain-induced mood changes equally with both preparations compared with a washout period with no drug treatment. The spray showed significantly faster onset of action than the gel on the SPI. 39 of 40 patients on both active treatments reported no gastrointestinal irritation. Subscales of the SPI also showed highly significantly improved pain-induced mood disturbance. Conclusions: Diclofenac gel and spray significantly improved osteoarthitic knee pain. Patient well-being was also significantly improved on the SPI. The spray showed significantly faster onset of action than the gel on the SPI.

Reliability, validity, and clinical utility of the Migraine-ACT questionnaire.

Background.—The 4‐item Migraine‐ACT questionnaire is an assessment tool for use by primary care physicians to identify patients who require a change in their current acute migraine treatment. It has been shown to be easy to use, and to be reliable and accurate in its assessments.

Identifying patients who require a change in their current acute migraine treatment: the Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire.

Abstract.The aim of the study was to design and test a new, easy to use, assessment tool, the Migraine Assessment of Current Therapy (Migraine-ACT), for identifying patients who require a change in their acute treatment. A 27-item questionnaire was developed by an international advisory board including questions formulated in four domains: headache impact, global assessment of relief, consistency of response and emotional response. Migraine patients entered a multinational, prospective study to investigate the test-retest reliability and construct validity of the tool, which was completed by the patients on two occasions. Test-retest reliability was assessed by Pearson’s and by Spearman correlation coefficients. Construct validity was assessed by correlating patients’ answers to the 27-item questionnaire with those of well-reported measures: SF-36, MIDAS and Migraine Therapy Assessment Questionnaire (MTAQ). The test-retest reliability of the 27 initial questions ranged from good to excellent. Correlations of all items with SF-36, MIDAS and MTAQ scores—assessed by discriminatory t-tests—indicated that the following 4 were the most discriminating items: Does your migraine medication work consistently, in the majority of your attacks? Does the headache pain disappear within 2 hours? Are you able to function normally within 2 hours? Are you comfortable enough with your medication to be able to plan your daily activities? The 4-item Migraine-ACT is a brief, simple, and reliable assessment tool to identify patients who require a change in their acute migraine treatment, and can be recommended for primary care physicians, neurologists and headache clinicians.

Comparison of internal reliability and validity of the McGill Pain Questionnaire and the Short Pain Inventory

SummaryWe compared the psychometric properties of the McGill Pain Questionnaire (MPQ) with the 17-item Short Pain Inventory© (SPI) in 60 outpatients with osteoarthritic knee pain. Split-half reliability, Guttman split-half reliability, Cronbach alpha and the correlation between the first and second half of the test were higher in the SPI total pain disturbance than any of the summary or subscales of the MPQ: 0.94, 0.94. 0.88 and 0.90, versus 0.71, 0.70, 0.69 and 0.55 for the MPQ sensory present pain intensity, 0.59, 0.57, 0.65 and 0.43 for the affective and 0.62, 0.55, 0.49 and 0.45 for the evaluative MPQ scale, respectively. The parameters for the SPI total mood disturbance were superior to all MPQ-derived scales. Dividing into high and low ‘pain experienced right now’ identified screening samples. The SPI ‘pain right now’ was more discriminating than the comparative MPQ item on both the SPI and MPQ. Additionally, none of the summary scales of the MPQ could show significant internal discrimination whereas the SPI did achieve this.There were 23 significant correlations with the SPI severity compared with 15 with the MPQ. SPI sadness, anxiety, anger, total mood disturbance and total pain disturbance were significantly correlated with the MPQ severity rating. The MPQ variables fared less well than the SPI in the degree of association between various pain parameters and physical severity.Factor analyses revealed that the SPI accounts for the majority of the variance (50%) compared with 17% for Factor 2. This second factor is best indexed by the McGill ‘pain now’ and also with the SPI ‘pain severity now’ item. Since the SPI indexes the severity as accurately (0.79) as the McGill, the only difference between the two is the sensory MPQ variance. However, since the SPI (Factor 1) also indexes some of the common variance of the MPQ sensory variable, the SPI also gains in this respect. If it were the case that the outcome of an analgesic clinical trial was the sensory aspects of the pain (cutting, throbbing, rasping) then the McGill should be the obvious outcome measure. For the patient, the most important feature of pain surely must be the physical severity and the unpleasantness of the experience. The MPQ is a rather long procedure and the evaluative scale is of dubious value. The majority of the pain variance is captured by the SPI and, secondly, by the sensory aspect of the MPQ. The SPI measures the emotional aspects of pain well and the McGill assesses the physical or sensory aspects of pain better than any other available. Both have their place according to one’s research interests and the clinical relevance. For example, if an investigation involves opiates like morphine, the SPI may be the better placed instrument, since the induced euphoria may present as a patient who can still feel the pain but is no longer bothered by it. Algesimetry requires measuring both the physical and emotional sensations of the patient.

Comparative Central Nervous System Effects and Pharmacokinetics of Neu-metoclopramide and Metoclopramide in Healthy Volunteers

Metoclopramide, a drug used for the relief of nausea and emesis, is currently under development as a radio‐ and chemosensitizing agent. Its usefulness in high doses, however, is limited by its central nervous system side effects. Neu‐metoclopramide (Neu Sensamide), a novel, concentrated, phosphate‐buffered, pH‐adjusted (pH = 6.5–7.0) formulation of metoclopramide, has been shown to have an improved side‐effect profile in animal studies. The present double‐blind, four‐way crossover study compared the central nervous system effects and pharmacokinetics of neu‐metoclopramide (intravenously and intramuscularly at 1.8 mg/kg) with intravenous metoclopramide and intramuscular placebo in 19 healthy male volunteers. Eight participants withdrew from the study, one because of noncompliance and seven because of adverse events. A total of 28 central nervous system events were observed with intravenous metoclopramide administration, whereas 16, 15, and 6 such events were attributed to intravenous neu‐metoclopramide, intramuscular neu‐metoclopramide, and placebo, respectively. Extra pyramidal effects occurred on 10 occasions: 7 after intravenous metoclopramide, 2 after intravenous neu‐metoclopramide, and 1 after intramuscular neu‐metoclopramide. No significant differences were observed in the pharmacokinetic profiles of the three formulations of metoclopramide. It may be speculated, therefore, that the molecular conformational changes inherent to neu‐metoclopramide result in a reduced side‐effect profile compared with conventional metoclopramide formulations.

The Headache Impact Test® 1 and the Short Pain Inventory©

AbstractBackground: The psychometric properties of the Headache Impact Test® (HIT) were compared with the 17-item Short Pain Inventory© (SPI) in 75 primary-care patients presenting with headache. A specialist neurologist made formal diagnoses consistent with the International Headache Society classification. We compared the severity of the headaches and the diagnostic labels with the ability of the SPI and the HIT to discriminate severity and diagnosis. Aim: To compare and contrast the psychometrics of the HIT and the SPI in headache patients in relation to pain severity and diagnosis. Methods: The dynamic version of the computerized HIT (HIT-DYNHA®) was used via the Internet. Patients were given a total of 7 days’ supply of the SPI to use from the start of their next headache and to continue over the following week. Neither the HIT nor the SPI claim to be diagnostic tests, but both claim to be reliable and valid outcome measures of headache. Both tests were compared by screening samples identified by: no pain, mild, moderate, severe or extreme pain. They were further stratified into: chronic daily headache, migraine and acute tension-type headache. This tests the power to resolve small differences in severity for each type of headache. Results: The HIT correlated 0.283 with the severity of the headaches whereas the SPI correlated 0.768 on Total Pain Disturbance. The correlations of the HIT and the SPI mood scales with pain severity never rose above 0.26 whereas the correlations of the SPI were typically 0.7. The SPI produced highly significant discriminability of the severity intervals (no pain, mild, moderate, severe, extreme) with Student t-test values of 2–20. The HIT scores were far less powerful at discriminating severity with t-test values from 2–5. The SPI has far better discrimination than the HIT at resolving the fine detail of severity. HIT scores at screening produced significant discrimination of the diagnoses with the resolution between tension-type headache and chronic daily headache reaching 1/100 million. The SPI summary scores and subscales did not discriminate between diagnoses. Confirmatory factor analyses were carried out including headache diagnosis, SPI and HIT variables. Various Quartimax and Varimax analyses strikingly gave the same two factors of severity and diagnosis. The first factor’s major correlation loading was the SPI ‘total pain disturbance’ (0.97) and loading highly on all SPI subscales (0.852–0.92) and severity (0.77). The HIT loading was −0.17 and diagnosis loaded 0.16. The second factor was identified and loaded as ‘diagnosis’ (0.94) with HIT loading t−0.80. The SPI and severity subscales were correlation loaded 0–0.12 and severity 0.2. The HIT and the SPI clearly measure different things. Conclusion: The HIT was poorly related to the severity of the pain but very closely related to the diagnostic label. In contrast, the SPI was very closely related to pain severity but not related to diagnoses.

Survey of pain in two medical and dental clinics with non-patient controls using the Short Pain Inventory©

SummaryWe compared pain measured by the 17-item Short Pain Inventory© in two samples of dental patients with two medical samples and with two non-patient samples. We contrasted all six samples to pilot the use of the inventory as an aid to clinicians in the evaluation of pain experienced by dental and medical patients. Six parallel groups of patients (n=266) were contrasted on pain severity, total mood disturbance and subscales of pain induced mood disturbance. The ability to discriminate between different patient groups and between pain—non-pain, indexed validity. Test-retest reliability and internal reliability were also computed.Patients attending the King’s emergency dental clinic showed the highest pain disturbance compared with all other groups. The order of magnitude of pain disturbance thereafter was in the general order of Chronic Pain Clinic > Beckton General Dental Practice > Osteoarthritic knee outpatients > stressed teachers and normal healthy non-patients. The SPI was successful at revealing significant differences in pain severity and pain-related mood disturbance, relating to the global well being of the patient. Significant group differences were also seen in pain-induced anger, sadness, sedation, anxiety and social interaction. We conclude that the SPI gives valuable, reliable and valid pain information. It may helpful in the management of dental and medical patients and in future clinical trials.