Migraine

Outcome Measures for Assessing the Effectiveness of Non-pharmacological Interventions in Frequent Episodic or Chronic Migraine: A Delphi Study

The Chiro.Org Blog

SOURCE:   BMJ Open. 2020 (Feb 12); 10 (2): e029855

Kerstin Luedtke, Annika Basener, Stephanie Bedei, Rene Castien, Aleksander Chaibi, et al

Pain and Exercise Research,
Universitat zu Lubeck Sektion Medizin,
Lubeck, Germany
kerstin.luedtke@uni-luebeck.de

OBJECTIVES:   The aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients.

SETTING:   University-initiated international survey.

PARTICIPANTS:   The expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers.

PROCEDURES:   The initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache.

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Global, Regional, and National Burden of Migraine and Tension-type Headache, 1990-2016: A Systematic Analysis for the Global Burden of Disease Study 2016

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SOURCE:   Lancet Neurol. 2018 (Nov); 17 (11): 954–976

GBD 2016 Headache Collaborators

Prof Lars Jacob Stovner,
Department of Neuromedicine and Movement Science,
Norwegian University of Science and Technology,
Trondheim N-7491, Norway

BACKGROUND:   Through the Global Burden of Diseases, Injuries, and Risk Factors (GBD) studies, headache has emerged as a major global public health concern. We aimed to use data from the GBD 2016 study to provide new estimates for prevalence and years of life lived with disability (YLDs) for migraine and tension-type headache and to present the methods and results in an accessible way for clinicians and researchers of headache disorders.

METHODS:   Data were derived from population-based cross-sectional surveys on migraine and tension-type headache. Prevalence for each sex and 5–year age group interval (ie, age 5 years to ≥95 years) at different time points from 1990 and 2016 in all countries and GBD regions were estimated using a Bayesian meta-regression model. Disease burden measured in YLDs was calculated from prevalence and average time spent with headache multiplied by disability weights (a measure of the relative severity of the disabling consequence of a disease). The burden stemming from medication overuse headache, which was included in earlier iterations of GBD as a separate cause, was subsumed as a sequela of either migraine or tension-type headache. Because no deaths were assigned to headaches as the underlying cause, YLDs equate to disability-adjusted life-years (DALYs). We also analysed results on the basis of the Socio-demographic Index (SDI), a compound measure of income per capita, education, and fertility.

FINDINGS:   Almost three billion individuals were estimated to have a migraine or tension-type headache in 2016: 1·89 billion (95% uncertainty interval [UI] 1·71–2·10) with tension-type headache and 1·04 billion (95% UI 1·00–1·09) with migraine. However, because migraine had a much higher disability weight than tension-type headache, migraine caused 45·1 million (95% UI 29·0–62·8) and tension-type headache only 7·2 million (95% UI 4·6–10·5) years lived with disability (YLDs) globally in 2016. The headaches were most burdensome in women between ages 15 and 49 years, with migraine causing 20·3 million (95% UI 12·9–28·5) and tension-type headache 2·9 million (95% UI 1·8–4·2) YLDs in 2016, which was 11·2% of all YLDs in this age group and sex. Age-standardised DALYs for each headache type showed a small increase as SDI increased.

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Chiropractic Spinal Manipulative Therapy For Migraine: A Three-Armed, Single-Blinded, Placebo, Randomized Controlled Trial

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SOURCE:   Eur J Neurol. 2016 (Oct 2) [Epub]

Aleksander Chaibi, Jurate Šaltyte Benth, Peter J Tuchin, Michael Bjørn Russell

Head and Neck Research Group,
Akershus University Hospital,
Lørenskog, Norway.

BACKGROUND AND PURPOSE:   To investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs.

METHODS:   This was a prospective three-armed, single-blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1-month run-in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow-up. The primary end-point was the number of migraine days per month, whereas secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.

RESULTS:   Migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow-up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow-up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.

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Chiropractic Spinal Manipulative Therapy for Migraine: A Study Protocol of a Single-blinded Placebo-controlled Randomised Clinical Trial

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SOURCE:   BMJ Open. 2015 (Nov 19);   5 (11):   e008095 ~ FULL TEXT

Aleksander Chaibi, Jurate Šaltyte Benth, Peter J Tuchin, Michael Bjørn Russell

Head and Neck Research Group,
Research Centre, Akershus University Hospital,
Lørenskog, Norway Institute of Clinical Medicine,
Akershus University Hospital,
University of Oslo,
Nordbyhagen, Norway

INTRODUCTION:   Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT).

METHOD AND ANALYSIS:   According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs.

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