Department of Rehabilitation Medicine, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.
Department of Rehabilitation Medicine, Erasmus MC - University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
Mult Scler. 2017 Oct;23(11):1527-1541. doi: 10.1177/1352458517702751. Epub 2017 May 22.
Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS).
To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue.
A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA).
Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35).
The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.
疲劳是多发性硬化症(MS)中一种常见且使人致残的症状。
研究个体能量守恒管理(ECM)干预对原发性 MS 相关疲劳患者的疲劳和参与情况的有效性。
共有 86 名严重疲劳且能行走的 MS 确诊患者参与了这项单盲、两平行臂随机临床试验,他们被随机分配到 ECM 组或仅提供信息的对照组,在门诊康复科进行治疗。在基线和随机分组后 8、16、26 和 52 周时进行盲法评估。主要结局是疲劳(Checklist Individual Strength - CIS20r 的疲劳子量表)和参与度(参与和自主量表 - IPA)。
基于 76 名随机患者(ECM 组,n=36;MS 护士组,n=40)进行了改良意向治疗分析。在疲劳方面,ECM 没有显著效果(组间 CIS20r 的总体差异为-0.81;95%置信区间(CI),-3.71 至 2.11),也没有对 IPA 的五个领域中的四个领域产生影响。在 ECM 组中,IPA 领域社会关系的总体效果不佳(组间差异为 0.19;95%CI,0.03 至 0.35)。
本研究中使用的个体 ECM 形式并没有比仅提供信息的对照组更能减轻 MS 相关的疲劳和参与受限。