Sobell Department of Motor Neuroscience and Movement Disorders, UCL Institute of Neurology, London, UK.
Therapy Services Department, National Hospital for Neurology and Neurosurgery, London, UK.
J Neurol Neurosurg Psychiatry. 2017 Jun;88(6):484-490. doi: 10.1136/jnnp-2016-314408. Epub 2016 Sep 30.
To determine the feasibility of conducting a randomised controlled trial of a specialist physiotherapy intervention for functional motor symptoms (FMS).
A randomised feasibility study was conducted recruiting patients with a clinically established diagnosis of FMS from a tertiary neurology clinic in London, UK. Participants were randomised to the intervention or a treatment as usual control. Measures of feasibility and clinical outcome were collected and assessed at 6 months.
60 individuals were recruited over a 9-month period. Three withdrew, leaving 29 intervention and 28 controls participants in the final analysis. 32% of patients with FMS met the inclusion criteria, of which 90% enrolled. Acceptability of the intervention was high and there were no adverse events. At 6 months, 72% of the intervention group rated their symptoms as improved, compared to 18% in the control group. There was a moderate to large treatment effect across a range of outcomes, including three of eight Short Form 36 (SF36) domains (d=0.46-0.79). The SF36 Physical function was found to be a suitable primary outcome measure for a future trial; adjusted mean difference 19.8 (95% CI 10.2 to 29.5). The additional quality adjusted life years (QALY) with intervention was 0.08 (95% CI 0.03 to 0.13), the mean incremental cost per QALY gained was £12 087.
This feasibility study demonstrated high rates of recruitment, retention and acceptability. Clinical effect size was moderate to large with high probability of being cost-effective. A randomised controlled trial is needed.
NCT02275000; Results.
确定对功能性运动症状（FMS）进行专业物理治疗干预的随机对照试验的可行性。
在英国伦敦的一家三级神经病学诊所，进行了一项随机可行性研究，招募了具有临床确诊 FMS 的患者。参与者被随机分配到干预组或常规治疗对照组。在 6 个月时收集并评估可行性和临床结果测量。
在 9 个月的时间内招募了 60 名个体。3 名退出，最终分析中留下 29 名干预组和 28 名对照组参与者。32%的 FMS 患者符合纳入标准，其中 90%的患者入组。干预措施的可接受性高，没有不良事件。6 个月时，72%的干预组患者认为自己的症状有所改善，而对照组为 18%。在一系列结果中，包括 8 个简短健康调查问卷（SF36）领域中的 3 个（d=0.46-0.79），都有中度到较大的治疗效果。SF36 身体功能被认为是未来试验的合适主要结局指标；调整后平均差异 19.8（95%CI 10.2 至 29.5）。干预组额外的质量调整生命年（QALY）为 0.08（95%CI 0.03 至 0.13），每获得一个 QALY 的增量成本为 12087 英镑。
这项可行性研究表明，招募、保留和可接受性的比例较高。临床效果大小为中到大，具有较高的成本效益可能性。需要进行随机对照试验。
NCT02275000；结果。
