Efficacy of Restricted Acute Medication Intake Compared to no Acute Medication Intake During a Two Months Detoxification Period in Medication-overuse Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Headache frequency
研究概览
简要总结
Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting approximately 63 million people worldwide. MOH is a potentially treatable condition, and there are different opinions among headache specialists concerning the correct treatment strategy.
The study is a prospective longitudinal open-label randomized controlled study comparing two detoxification programs conducted in a tertiary headache care center. Patients with MOH are either randomized to treatment in program A or program B. In program A, patients undergo detoxification without any acute medication during a two months period (complete stop of acute medication intake). In program B, patients was allowed to take up to 2 days a week with analgesics or migraine medication during the two months detoxification period (restricted acute medication intake). Both A and B are out-patient programs, and patients in both groups receive patient education, consisting of six lessons, managed by specialized headache nurses in collaboration with specialized psychologists and physiotherapists (Figure 1). All patients are also offered rescue medication (levomepromazine or promethazine) and antiemetics, if necessary.
The need for prophylactic treatment is evaluated individually after 2-month detoxification. Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked to continuously register headache calendar and to fulfill questionnaires at all the follow-up visits. In addition they are asked to fill out questionnaires (Headache Under-Response to Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity of Dependence Score (SDS), World Health Organization Quality of Life Score(WHO QoL) and Dolo-score) at baseline, 2, 6 and 12 months
详细描述
Patients with contact to Danish headache center are recruited consecutively. The MOH-diagnosis is based on least 3 months previous detailed history and at least 1 month fulfilled headache diary or headache calendar prior to the visit.
Patients were allocated to either program A or B by a concealed randomization process. The patients were randomized in blocks of 10 by use of opaque, sealed envelopes.
Statistics Statistical Package for Social Sciences (SPSS) version 22 is used for statistical calculations. Continuous variables are presented as mean (SD) and median (25-75 percentiles). For normal distributed continuous variables the investigators use paired and unpaired student's T-test, while for skewed distribution the investigators used Mann-Whitney test. Categorical variables is presented as percentage (N), and analyzed by chi-square test. All results are shown as intention-to-treat (ITT). The p-value is two-sided and p ≤ 0.05 is considered as significant.
The primary outcome is reduction in headache days per month. Clinical relevant difference is estimated to 20% between the two groups. The standard deviation based on previous published literature was estimated to 35%. Accepting an alfa-error on 5% and 80% power, 80 patients are needed. Based on previous studies, it is assumed that the drop-out rate will be approximately 15-20%. Therefore the investigators aim to include 100 patients corresponding to 50 in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MOH-diagnosis according to ICHD-3beta
- •Eligible for out-patient care
- •Previously diagnosed with primary headache forms.
排除标准
- •Previously diagnosed with secondary headache forms
- •Significant physical or psychiatric illness
- •Pregnancy or breastfeeding
- •Inadequate language skills to follow the patient education and filling out questionnaires.
研究组 & 干预措施
Protocol A
In program A, patients underwent detoxification without any acute medication during a two months period (complete stop of acute medication intake).
干预措施: Detoxification (Other)
Protocol B
In program B, patients were allowed to take up to 2 days a week with analgesics or migraine medication during the two months detoxification period (restricted acute medication intake).
干预措施: Detoxification (Other)
结局指标
主要结局
Headache frequency
时间窗: 6 months
次要结局
- Scores from questionnaires Dolo-score(6 and 12 months)
- Headache intensity (Total intensity per month meassured by headache calendars).(6 and 12 months)
- Scores from questionnaires Hospital Anxiety and Depression Score (HADS)(6 and 12 months)
- Days with acute medication/ month(6 and 12 month)
- Scores from questionnaires Headache Under-Response to Treatment (HURT)(6 and 12 months)
- Headache frequency(12 months)
- Scores from questionnaires World Health Organization Quality of Life score(6 and 12 months)
- Scores from questionnaires Severity of Dependence Score (SDS)(6 and 12 months)
研究者
Louise Carlsen
MD; PhD-student
Danish Headache Center