未经评估:最近的研究表明,使用开放标签安慰剂(OLP)可以改善各种医疗条件下的症状。这项为期3周的随机对照试验的主要目的是检查OLP治疗对疼痛的影响,功能性残疾,关节炎性膝关节疼痛患者的活动能力。
未经批准:60名患者(55%为女性;平均年龄,66.9±9.7SD年)随机分为两种OLP治疗(n=41)或不治疗(NT;n=19)。OLP治疗伴随着口头建议“减少疼痛”(OLP-疼痛,n=20)或“改善情绪”(OLP-情绪,n=21)。在患者日记中的11点数字评定量表(NRS)上监测疼痛和情绪水平,在研究结束时评估总体临床改善(CGI-I).在基线和21天后,患者填写了经过验证的问卷,以评估膝关节的症状和功能障碍(WOMAC),精神和身体生活质量(SF-36),状态焦虑(STAI状态),感知压力(PSQ-20),和自我效能感(GSE)。此外,膝关节活动度(中性零方法),心率变异性(HRV),治疗前后进行昼夜皮质醇水平评价。
UNASSIGNED:对每日疼痛评分的评估表明,与NT相比,OLP组的疼痛显着降低(p=0.013,d=0.64),OLP疼痛和OLP情绪组之间没有差异(p=0.856,d=0.05)。OLP治疗也改善了WOMAC疼痛(p=0.036,d=0.55),再次,两个OLP组之间没有差异(p=0.65,d=0.17)。WOMAC功能和刚度,膝盖活动能力,压力,状态焦虑,生活质量,自我效能感在组间没有不同的变化。
UNASSIGNED:OLP治疗可改善老年有症状的膝骨关节炎(OA)患者的膝关节疼痛,而膝关节的功能障碍和活动能力没有改变。口头建议的内容不太重要。OLP给药可被认为是有症状的膝关节OA的老年患者的支持性镇痛治疗。
UNASSIGNED:德国临床试验注册(https://www.drks.de/),DRKS00015191(回顾性注册)。
UNASSIGNED: Recent studies indicate that the administration of open-label placebos (OLP) can improve symptoms in various medical conditions. The primary aim of this 3-week randomized controlled trial was to examine the effects of OLP treatments on pain, functional disability, and mobility in patients with arthritic knee pain.
UNASSIGNED: Sixty patients (55% females; mean age, 66.9 ± 9.7 SD years) were randomized to one of two OLP treatments (n = 41) or no treatment (NT; n = 19). OLP treatments were accompanied by the verbal suggestion \"to decrease pain\" (OLP-pain, n = 20) or \"to improve mood\" (OLP-mood, n = 21). Pain and mood levels were monitored on 11-point Numeric Rating Scales (NRSs) in a patient diary, and global clinical improvement (CGI-I) was assessed at the end of the study. At baseline and after 21 days, patients filled in validated questionnaires to assess symptoms and functional disability of the knee (WOMAC), mental and physical quality of life (SF-36), state anxiety (STAI-state), perceived stress (PSQ-20), and self-efficacy (GSE). In addition, knee mobility (neutral zero-method), heart rate variability (HRV), and diurnal cortisol levels were evaluated before and after treatment.
UNASSIGNED: Evaluation of daily pain ratings indicated significant pain decrease in the OLP groups compared to NT (p = 0.013, d = 0.64), with no difference between the OLP-pain and the OLP-mood groups (p = 0.856, d = 0.05). OLP treatment also improved WOMAC pain (p = 0.036, d = 0.55), again with no difference between the two OLP groups (p = 0.65, d = 0.17). WOMAC function and stiffness, knee mobility, stress, state anxiety, quality of life, and self-efficacy did not change differently between groups.
UNASSIGNED: OLP treatment improved knee pain in elderly patients with symptomatic knee osteoarthritis (OA), while functional disability and mobility of the knee did not change. The content of the verbal suggestion was of minor importance. OLP administration may be considered as supportive analgesic treatment in elderly patients with symptomatic knee OA.
UNASSIGNED: German Clinical Trials Register (https://www.drks.de/), DRKS00015191 (retrospectively registered).