Effectiveness of a Health Education Programme as a Preventive Treatment for Chronic Migraine: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Headache frequency (days/month)
研究概览
简要总结
Chronic migraine (CM) is a common and frequent disorder, which has a major impact on the quality of life of migraine sufferers, interfering with physical function, productivity at work, personal life and leisure, lifestyle and psychological well-being.
The use of a prophylactic drug treatment is recommended if headache is present more than 8 days per month. In addition, several studies have shown benefits of non-pharmacological interventions such as self-management strategies, manual therapy and exercise. However, no studies have been found that analyse the beneficial effect of a combination of a preventive drug treatment and a health education programme.
Thus, this project would offer a service of health education through a telerehabilitation programme for patients with chronic migraine under prophylactic drug treatment.
The aim of this study is to compare the combination of a prophylactic drug therapy and a health education programme in the preventive treatment of patients with chronic migraine.based on the hypothesis that a health education program for chronic migraine patients could decrease the number of migraine days.
详细描述
Design:
A randomised, double-blind, controlled clinical trial will be conducted in two parallel groups, in which all patients with migraine chronic are receiving prophylactic drug treatment with Fremanezumab or Erenumab as prescribed by a physician. Moreover, patients in the experimental group will receive a health education programme and patients in the control group will receive a programme of general recommendations.
Intervention:
A 4-week baseline data collection period is included to record the frequency and intensity of migraine pain before starting the study.
The intervention will be carried out for 6 months with a follow-up at 1, 3 and 12 months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-65 years.
- •Patients diagnosed with CM following the ICHD-III criteria.
- •Patients with migraine onset before the age of 50 years.
- •Patients who have been diagnosed with chronic migraine for at least 1 year.
排除标准
- •Women who are pregnant or breastfeeding.
- •Women with menstrual migraine.
- •Patients with severe or unstable psychiatric pathology that contraindicates the use of drug treatment.
- •Allergic patients or those who show sensitivity to components of the drug treatment.
- •Patients who refuse to sign the informed consent form or to participate in the study.
- •Patients who decide not to continue in the study.
结局指标
主要结局
Headache frequency (days/month)
时间窗: baseline (30 days after intervention), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).
Changes in number of days/month of headache following the criteria of "The International Classification of Headache Disorders (ICHD-III). Headache frequency will be assessed with a headache diary.
次要结局
- Allodynia Symptom Checklist (ASC-12)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- Analgesic medication(baseline (30 days after intervention), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- The six-item Headache Impact Test (HIT-6)(pre-intervention (day 1), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- Pollutants(baseline (30 days after intervention), before intervention, month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- Pressure pain threshold (PPT)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- Headache intensity(baseline (30 days after intervention), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- Temporal summation (TS)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3).)
- International physical activity questionnaire (IPAQ) short-form.(pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).)
- Chronic Pain Self-efficacy Scale(pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).)
- Migraine Disability Assessment (MIDAS)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 9 (follow-up 2), month 12 (follow-up 3).)
- Hospital Anxiety and Depression (HADS)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).)
- Satisfaction scale(month 6 (post-intervention).)
- Pain Catastrophizing Scale (PCS)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).)
- Tampa Scale for Kinesiophobia (TSK)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).)
- Pittsburg Sleep Quality Index (PSQI)(pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).)
研究者
Dr. Pablo Herrero Gallego
PT, PhD
Universidad de Zaragoza