NCT02993289Unknown不适用
Is Detoxification Needed in Medication-overuse Headache?: A Randomized Controlled Trial of 3 Treatment Strategies
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Reduction in headache days per month in group A and C compared to group B.
研究概览
简要总结
Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to European guidelines and based on evidence, multidisciplinary detoxification is the first choice of treatment for MOH. However, consensus about the details in such detoxification programs is lacking. Contrary, other headache specialists believe more in treating chronic headache with medication overuse with single-therapy of prophylaxis and no withdrawal of acute medication, based on randomized controlled double-blinded placebo trial with prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to detoxification. However there was no significant difference.
AIM:
- To compare three different treatment protocols in order to improve the therapy of MOH.
- To test several baseline variables for being potential predictors for good treatment outcome.
- To examine the role of epigenetics in MOH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed MOH diagnosis according to the ICHD-III beta (1).
- •Eligible for outpatient treatment based on type of medication overuse (without massive pure opioids and barbiturates overuse), and personal resources and motivation.
- •Capable of completing headache diary/calendar.
- •Age ≥ 18 years old and capable of providing informed consent.
- •Medication-overuse headache based on initial tension-type headache (TTH) or migraine.
- •Signed informed consent.
排除标准
- •Severe physical illness or psychiatric disorders.
- •Addiction to alcohol or other drugs.
- •Current treatment with headache prophylaxis. Patients can be included minimum 5 weeks after stop of prophylaxis.
- •Pregnancy, breastfeeding or planned pregnancy within the next 12 months.
- •Inability to provide reliable information about medical history.
- •Criteria for Control group 1 - Episodic migraineurs:
- •Episodic migraine, with/without concomitant tension-type headache, according to the ICHD-III beta.
- •Headache days / month ≤ 6 at time of inclusion.
- •Days with analgesics / month ≤ 6 at time of inclusion.
- •Prophylactics are allowed.
- •Age ≥ 18 years old.
- •Ability to fill out headache calendar.
- •No previous medication overuse.
- •No significant co-morbid pain, physical or psychiatric disorders.
- •No addiction to alcohol or drug-abuse.
- •No pregnancy, breastfeeding or planned pregnancy within the next 12 months.
- •Criteria for Control group 2 - Healthy volunteers:
- •≥ 2 days with headache in the past month at time of inclusion.
- •Days with analgesics / month ≤ 6 at time of inclusion.
- •Age ≥ 18 years old.
- •No significant co-morbid pain, physical or psychiatric disorders.
- •No addiction to alcohol or drug-abuse.
- •No pregnancy, breastfeeding or planned pregnancy within the next 12 months.
结局指标
主要结局
Reduction in headache days per month in group A and C compared to group B.
时间窗: Six months follow-up
次要结局
- Reduction in headache days per month(Two and 12 months follow-up and 4 years)
- Reduction in days/month with use of analgesics and/or migraine medication.(Two, 6 and 12 months follow-up and 4 years)
- Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%).(Two, 6 and 12 months follow-up and 4 years)
- Reduction in headache intensity.(Two, 6 and 12 months follow-up and 4 years)
- Descriptive report of self-reported adverse effects of treatments.(Two, 6 and 12 months follow-up)
- Changes in Headache Under-Response to Treatment (HURT)-score.(Two, 6 and 12 months follow-up)
- Drop-out rate.(One, 2, 4, 6, 9 and 12 months follow-up and 4 years)
- Changes in Hospital Anxiety and Depression Scale (HADS).(Six and 12 months follow-up)
- Changes in Quality of Life (QoL) score.(Six and 12 months follow-up)
- Changes in Severity of Dependence Score (SDS).(Six and 12 months follow-up)
- Changes in Perceived Stress Score (PSS).(Twelve months follow-up.)
- Patient's satisfaction questionnaire(Two, 6 and 12 months follow-up)
研究者
Louise Carlsen
Medical doctor, PhD-student
Danish Headache Center
研究点 (2)
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