Department of Rehabilitation, Research School CAPHRI, Maastricht University; Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences.
Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences; Research Centre Technology in Care, Faculty of Health, Zuyd University of Applied Sciences, Heerlen; Department Health Research Services, Research School CAPHRI, Maastricht University.
J Physiother. 2015 Jan;61(1):42; discussion 42. doi: 10.1016/j.jphys.2014.08.006. Epub 2014 Oct 16.
Non-pharmacological interventions such as mirror therapy are gaining increased recognition in the treatment of phantom limb pain; however, the evidence in people with phantom limb pain is still weak. In addition, compliance to self-delivered exercises is generally low. The aim of this randomised controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and limitations in daily activities compared to traditional mirror therapy and care as usual in people following lower limb amputation.
A three-arm multi-centre randomised controlled trial will be performed. Participants will be randomly assigned to care as usual, traditional mirror therapy or mirror therapy supported by telerehabilitation. During the first 4 weeks, at least 10 individual sessions will take place in every group. After the first 4 weeks, participants will be encouraged to perform self-delivered exercises over a period of 6 weeks. Outcomes will be assessed at 4 and 10 weeks after baseline and at 6 months follow-up. The primary outcome measure is the average intensity of phantom limb pain during the last week. Secondary outcome measures include the different dimensions of phantom limb pain, pain-related limitations in daily activities, global perceived effect, pain-specific self-efficacy, and quality of life.
Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.
非药物干预措施，如镜像疗法，在治疗幻肢痛方面得到了越来越多的认可；然而，其在幻肢痛患者中的证据仍然不足。此外，自我实施锻炼的依从性通常较低。本随机对照研究的目的是比较下肢截肢后接受常规护理、传统镜像疗法和远程康复支持的镜像疗法对幻肢痛的强度、持续时间和频率以及日常生活活动受限的影响。
将进行一项三臂多中心随机对照试验。参与者将被随机分配到常规护理、传统镜像疗法或远程康复支持的镜像疗法组。在前 4 周内，每个组至少进行 10 次个体治疗。在前 4 周之后，参与者将被鼓励在 6 周的时间内进行自我实施的锻炼。在基线后 4 周和 10 周以及 6 个月随访时评估结果。主要结局指标是最后一周幻肢痛的平均强度。次要结局指标包括幻肢痛的不同维度、与疼痛相关的日常生活活动受限、整体感知效果、疼痛特异性自我效能和生活质量。
在准备这项试验期间出现了一些关于研究设计的问题，将讨论这些问题以及对所做选择的理由。
