Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions, Parc de Salut Mar, C/ Llull 410, 08019, Barcelona, Spain.
Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
Trials. 2021 Jan 29;22(1):104. doi: 10.1186/s13063-021-05042-w.
Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as eye movement desensitization and reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients and if its potential is boosted with the addition of MtCS.
Forty-five patients with FM and a history of traumatic events will be randomly allocated to Waiting List, EMDR + active-MtCS, or EMDR + sham-MtCS. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, and wellbeing.
This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS.
ClinicalTrials.gov NCT04084795 . Registered on 2 August 2019.
纤维肌痛症（FM）是一种全身性、广泛性的慢性疼痛障碍，影响 2.7%的普通人群。近年来，不同的研究观察到 FM 与心理创伤之间存在很强的关联。因此，一种以创伤为重点的心理治疗，如眼动脱敏再处理（EMDR），结合一种非侵入性的大脑刺激技术，如多焦点经颅电流刺激（MtCS），可能是一种创新的辅助治疗选择。这项双盲随机对照试验（RCT）分析了 EMDR 疗法是否能有效减轻 FM 患者的疼痛症状，以及加入 MtCS 是否能增强其潜力。
45 名有创伤事件史的 FM 患者将被随机分配到等待名单、EMDR+主动-MtCS 或 EMDR+假-MtCS 组。治疗师和患者将对 MtCS 条件保持盲态，评估者将对 EMDR 和 MtCS 均保持盲态。所有患者将在基线、治疗后和治疗后 6 个月的随访时进行评估。评估将评估以下变量：社会人口学数据、疼痛、心理创伤、睡眠障碍、焦虑和情感症状以及幸福感。
这项研究将提供证据，证明 EMDR 疗法是否能有效减轻 FM 患者的疼痛症状，以及 EMDR 的效果是否可以通过 MtCS 增强。
ClinicalTrials.gov NCT04084795，于 2019 年 8 月 2 日注册。
