经颅直流电刺激治疗子宫内膜异位症慢性盆腔痛的随机对照Ⅱ期临床试验
Transcranial direct current stimulation to reduce chronic pelvic pain in endometriosis: phase II randomized controlled clinical trial.
机构信息
Department of Gynecology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin 13353, Germany.
Medizinische Klinik m. S. Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Berlin 12200, Germany.
出版信息
Pain Med. 2023 Jul 5;24(7):809-817. doi: 10.1093/pm/pnad031.
BACKGROUND
It is known that various chronic pain conditions lead to maladaptive changes in the central nervous system. Endometriosis is frequently associated with chronic pelvic pain (CPP). Its sufficient treatment remains a clinical challenge. Transcranial direct current stimulation (tDCS) has been shown to be a powerful method to reduce chronic pain. Therefore, this study aimed to investigate pain reduction via anodal tDCS in patients with endometriosis and CPP.
METHODS
This clinical phase II, placebo-controlled, randomized, parallel-design study included 36 patients with endometriosis and CPP. All patients had CPP, defined as a score of ≥3/10 on the visual analog scale for ≥3 months in the prior 6 months. Anodal or placebo tDCS (18 patients per arm) was applied over the primary motor cortex for 10 days. The primary outcome measure was the pressure pain threshold (objective pain measure), and secondary outcomes were the numerical rating scale score (subjective pain measure), Von Frey monofilaments, and disease- and pain-related questionnaires. Data were collected at baseline, after the 10-day stimulation, and at a follow-up session, which took place 1 week after the tDCS had ended. Statistical analyses were performed with analyses of variance and t tests.
RESULTS
Significant decreased pain perception in both pain measurements (pressure pain threshold and numerical rating scale score) was found for the active tDCS group compared with the placebo group. This proof-of-concept study shows that tDCS is a helpful supporting pain therapy for patients with endometriosis and CPP. Moreover, further analyses revealed that 1 week after the stimulation had ended, pain reduction as indexed by pressure pain threshold remained significantly decreased, which indicates possible long-term analgesic effects.
CONCLUSION
The present study provides evidence that tDCS is an effective therapy for pain reduction in endometriosis-associated CPP. The results support the notion that CPP is developed and maintained in the central nervous system, making a multimodal pain therapy necessary.
TRIAL REGISTRATION
www.ClinicalTrials.gov ID: NCT05231239.
背景
已知各种慢性疼痛状况会导致中枢神经系统的适应性变化。子宫内膜异位症常伴有慢性盆腔疼痛（CPP）。其充分治疗仍然是一个临床挑战。经颅直流电刺激（tDCS）已被证明是一种减轻慢性疼痛的有效方法。因此，本研究旨在探讨经颅直流电刺激对子宫内膜异位症和 CPP 患者疼痛的缓解作用。
方法
这是一项临床二期、安慰剂对照、随机、平行设计研究，纳入了 36 例患有子宫内膜异位症和 CPP 的患者。所有患者均有 CPP，定义为在过去 6 个月中，视觉模拟评分（VAS）≥3/10 且持续≥3 个月。在初级运动皮层给予阳极或安慰剂 tDCS（每组 18 例），共 10 天。主要结局测量指标为压力疼痛阈值（客观疼痛测量），次要结局测量指标为数字评分量表评分（主观疼痛测量）、Von Frey 单丝和疾病及疼痛相关问卷。数据在基线、10 天刺激后和 tDCS 结束后 1 周的随访中收集。统计分析采用方差分析和 t 检验。
结果
与安慰剂组相比，主动 tDCS 组在两种疼痛测量（压力疼痛阈值和数字评分量表评分）中均发现疼痛感知显著降低。这项概念验证研究表明，tDCS 是治疗子宫内膜异位症和 CPP 患者疼痛的一种有帮助的辅助治疗方法。此外，进一步分析表明，刺激结束后 1 周，压力疼痛阈值指数的疼痛减轻仍显著降低，这表明可能存在长期镇痛作用。
结论
本研究提供了证据表明 tDCS 是治疗子宫内膜异位症相关 CPP 疼痛的有效方法。结果支持 CPP 是在中枢神经系统中发展和维持的观点，这使得需要采用多模式疼痛治疗。
试验注册
www.ClinicalTrials.gov 注册号：NCT05231239。
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