Background

Transcranial direct current stimulation was suggested to provide beneficial effects in chronic migraine, a condition often associated with medication overuse for which no long-term therapy is available.

Methods

We conducted a randomised controlled trial to assess long-term efficacy of transcranial direct current stimulation. Adults diagnosed with chronic migraine and medication overuse were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham transcranial direct current stimulation daily for five consecutive days, along with standardised drug withdrawal protocol. Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophising, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period.

Results

We randomly allocated 135 patients to anodal (44), cathodal (45), and sham (46) transcranial direct current stimulation. At 6 and 12 months, the percentage of reduction of days of headache and number of analgesics per month ranged between 48.5% and 64.7%, without differences between transcranial direct current stimulation (cathodal, anodal, or the results obtained from the two arms of treatment, anodal plus cathodal) and sham. Catastrophising attitude significantly reduced at 12 months in all groups. There was no difference for the other secondary outcomes.

Conclusions

Transcranial direct current stimulation did not influence the short and long-term course of chronic migraine with medication overuse after acute drug withdrawal. Behavioral and educational measures and support for patients’ pain management could provide long-term improvement and low relapse rate.

Trial registration number NCT04228809

中文翻译：

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经颅直流电刺激对药物过度使用的慢性偏头痛无效：一项双盲、随机临床试验。

背景

建议经颅直流电刺激对慢性偏头痛提供有益效果，这种情况通常与药物过度使用有关，无法长期治疗。

方法

我们进行了一项随机对照试验来评估经颅直流电刺激的长期疗效。被诊断患有慢性偏头痛和药物过度使用的成人连续五天每天接受 1:1:1 比例的阳极、阴极或假经颅直流电刺激，以及标准化的药物戒断方案。主要结果是在 12 个月时每月头痛天数减少 50%。次要结果是 6 个月时每月头痛天数减少 50%，每月镇痛剂摄入量减少，以及残疾和生活质量的变化、灾难性、抑郁、状态和特质焦虑、依赖态度和异常性疼痛强度。在整个研究期间，患者不允许服用任何偏头痛预防药物。

结果

我们将 135 名患者随机分配到阳极 (44)、阴极 (45​​) 和假 (46) 经颅直流电刺激。在第 6 个月和第 12 个月时，头痛天数和每月镇痛药数量减少的百分比介于 48.5% 和 64.7% 之间，经颅直流电刺激（阴极、阳极或从两个治疗组获得的结果）之间没有差异，阳极加阴极）和假。所有组的灾难态度在 12 个月时显着降低。其他次要结果没有差异。

结论

经颅直流电刺激对急性停药后药物过度使用的慢性偏头痛的短期和长期病程没有影响。行为和教育措施以及对患者疼痛管理的支持可以提供长期改善和低复发率。

试用注册号 NCT04228809