ImportanceFunctional movement disorders (FMDs) are frequent and disabling neurological disorders with a substantial socioeconomic impact. Few randomized studies have analyzed the effectiveness of combined physiotherapy and psychotherapy in patients’ quality of life.ObjectiveTo assess the efficacy of multidisciplinary treatment (physiotherapy plus cognitive behavioral therapy) in FMDs.Design, Setting, and ParticipantsThis was a parallel, rater-blinded, single-center, randomized clinical trial. Recruitment took place from June 2022 to April 2023, and follow-up visits were performed at months 3 and 5, concluding in October 2023. Participants were recruited from a national referral center for movement disorders: the Movement Disorders Unit from the Hospital Universitario Virgen Rocio in Seville, Spain. Patients had to be 18 years or older with a confirmed FMD diagnosis and capable of giving consent to participate. Patients who did not meet eligibility criteria or refused to participate were excluded. Any uncontrolled psychiatric disorder was considered an exclusion criterion.InterventionsPatients were randomly assigned, in a ratio of 1:1 to multidisciplinary treatment (physiotherapy plus cognitive behavioral therapy), or a control intervention (psychological support intervention).Main Outcomes and MeasuresPrimary outcomes: between-group differences in changes from baseline to month 3 and month 5 in patients’ quality of life (EQ-5D-5L score: EQ Index and EQ visual analog scale [EQ VAS]; and 36-Item Short-Form Survey Physical Component Summary [SF-36 PCS] and SF-36 Mental Component Summary [MCS]). Linear mixed models were applied, controlling by baseline severity and applying Bonferroni correction.ResultsOf 70 patients screened with an FMD, 40 were enrolled (mean [SD] age, 43.5 [12.8] years; age range, 18-66 years; 32 female [80%]; mean [SD] age at FMD onset, 38.4 [12.1] years), and 38 completed all the follow-up visits and were included in the analysis for primary outcomes. Multidisciplinary treatment improved SF-36 PCS with a mean between-group difference at 3 months of 4.23 points (95% CI, −0.9 to 9.4 points; P = .11) and a significant mean between-group difference at 5 months of 5.62 points (95% CI, 2.3-8.9 points; P < .001), after multiple-comparisons adjustment. There were no significant differences in other quality-of-life outcomes such as SF-36 MCS (mean between-group difference at 3 and 5 months: 0.72 points; 95% CI, −5.5 to 7.0 points; P = .82 and 0.69 points; 95% CI, 2.3-8.9 points; P = .83, respectively), EQ VAS (9.34 points; 95% CI, −0.6 to 19.3 points; P = .07 and 13.7 points; 95% CI, −1.7 to 29.0 points; P = .09, respectively) and EQ Index (0.001 point; 95% CI, −0.1 to 0.1 point; P = .98 and 0.08 points; 95% CI, 0-0.2 points; P = .13, respectively). At months 3 and 5, 42% and 47% of patients, respectively, in the multidisciplinary group reported improved health using the EQ-5D system, compared with 26% and 16% of patients, respectively, in the control group.Conclusions and RelevanceResults show that multidisciplinary treatment (physiotherapy plus cognitive behavioral therapy) effectively improves FMD symptoms and physical aspects of patients’ quality of life. Further studies must be performed to evaluate the potential cost-effectiveness of this approach in FMD.Trial RegistrationClinicalTrials.gov Identifier: NCT05634486

中文翻译：

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功能性运动障碍的物理疗法和认知行为疗法相结合


重要性功能性运动障碍 (FMD) 是一种常见的致残性神经系统疾病，具有重大的社会经济影响。很少有随机研究分析物理治疗和心理治疗联合治疗对患者生活质量的有效性。目的评估多学科治疗（物理治疗加认知行为治疗）对口蹄疫的疗效。设计、设置和参与者这是一项并行的、评估者盲法的、单中心、随机临床试验。招募时间为 2022 年 6 月至 2023 年 4 月，并在第 3 个月和第 5 个月进行随访，于 2023 年 10 月结束。参与者是从国家运动障碍转诊中心招募的：圣女罗西奥大学医院运动障碍科在西班牙塞维利亚。患者必须年满 18 岁，确诊 FMD，并且能够同意参与。不符合资格标准或拒绝参加的患者被排除在外。任何不受控制的精神障碍均被视为排除标准。 干预措施 患者以 1:1 的比例被随机分配至多学科治疗（物理治疗加认知行为治疗）或对照干预（心理支持干预）。 主要结果和措施 主要结果：介于-患者生活质量从基线到第 3 个月和第 5 个月的变化的组间差异（EQ-5D-5L 评分：EQ 指数和 EQ 视觉模拟量表 [EQ VAS]；以及 36 项简短调查身体成分摘要[SF-36 PCS] 和 SF-36 心理组件摘要 [MCS]）。应用线性混合模型，通过基线严重程度进行控制并应用 Bonferroni 校正。结果 在 70 名接受 FMD 筛查的患者中，有 40 名患者入组（平均 [SD] 年龄为 43 岁）。5 [12.8] 年；年龄范围，18-66岁； 32 名女性 [80%]； FMD 发病时的平均 [SD] 年龄为 38.4 [12.1] 岁），38 人完成了所有随访并纳入主要结局分析。多学科治疗改善了 SF-36 PCS，3 个月时的平均组间差异为 4.23 分（95% CI，-0.9 至 9.4 点；P = .11），5 个月时的显着平均组间差异为 5.62 分（95% CI，2.3-8.9 分；P < .001），经过多重比较调整。 SF-36 MCS 等其他生活质量结果没有显着差异（3 个月和 5 个月的平均组间差异：0.72 分；95% CI，-5.5 至 7.0 分；P = 0.82 和 0.69分；95% CI，2.3-8.9 分；P = .83，分别），EQ VAS（9.34 分；95% CI，-0.6 至 19.3 分；P = 0.07 和 13.7 分；95% CI，-1.7 至29.0 点；P = .09，分别）和 EQ 指数（0.001 点；95% CI，-0.1 至 0.1 点；P = 0.98 和 0.08 点；95% CI，0-0.2 点；P = .13） ）。在第 3 个月和第 5 个月，多学科组中分别有 42% 和 47% 的患者报告使用 EQ-5D 系统改善了健康状况，而对照组中这一比例分别为 26% 和 16%。 结论和相关性结果研究表明，多学科治疗（物理治疗加认知行为治疗）可有效改善口蹄疫症状和患者身体方面的生活质量。必须进行进一步的研究来评估这种方法在 FMD 中的潜在成本效益。试验注册临床试验。政府标识符：NCT05634486