Zangi Heidi A, Haugmark Trond, Provan Sella Aarrestad
Health Service Research and Innovation Unit, REMEDY Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Box 23, Vinderen, Oslo, 0319, Norway.
Faculty of Health Science, Institute of Health, VID Specialized University, Oslo, Norway.
Rheumatol Int. 2025 Jan 7;45(1):19. doi: 10.1007/s00296-024-05778-z.
To examine changes in symptoms and health status in patients with fibromyalgia (FM) 24 months after participating in the mindfulness-based group-program, the Vitality Training (VTP), followed by physical exercise counselling. Seventy-six participants, mean age (range) 43 (26-52), females 69 (91%), diagnosed with FM according to the ACR 2011-criteria received the VTP in a previous randomised controlled trial. Control group participants could receive the VTP after a 12-month observation period, therefore only data from the intervention group were analysed in the present study. Self-reported data were collected electronically at baseline, 3, 12 and 24 months. Outcomes were patient global impression of change (PGIC), FM-severity, i.e. widespread pain (WPI) and symptom severity (SSS), pain, fatigue, sleep quality, psychological distress, motivation and barriers for physical activity, mindfulness and work participation. Trends across time-points were analysed using mixed models for repeated measurements. At 24-months, 48 (56.5%) participants responded, 94% female, median (range) age 46 (28-54), symptom duration 12 (5-33) years. Seven participants reported much/very much better on the PGIC; 21 (44%) reported no change/minimal improvement. Improvements were observed in WPI (-1.9, ES 0.4), SSS (-1.2, ES 0.6), fatigue (-0.8, p =.014) and self-efficacy for physical activity (1.4, ES 0.4). There was a significant trend of reduced WPI, SSS, pain and fatigue across the four time-points, but no additional improvements from 12 to 24-month follow-up. Participants who had completed the VTP demonstrated small to moderate improvements in symptom burden and FM-severity from baseline to 24-month follow-up. Trial registration number: ISRCTN96836577 https://doi.org/10.1186/ISRCTN96836577 , prospectively registered 12.07.2016.
为了研究纤维肌痛（FM）患者在参加基于正念的团体项目——活力训练（VTP）并接受体育锻炼咨询24个月后的症状和健康状况变化。76名参与者，平均年龄（范围）43岁（26 - 52岁），女性69名（91%），根据美国风湿病学会（ACR）2011年标准被诊断为FM，在之前的一项随机对照试验中接受了VTP。对照组参与者在12个月观察期后可接受VTP，因此本研究仅分析干预组的数据。在基线、3个月、12个月和24个月时通过电子方式收集自我报告数据。结局指标包括患者总体变化印象（PGIC）、FM严重程度，即广泛性疼痛（WPI）和症状严重程度（SSS）、疼痛、疲劳、睡眠质量、心理困扰、体育活动的动机和障碍、正念和工作参与度。使用重复测量的混合模型分析各时间点的趋势。在24个月时，48名（56.5%）参与者做出回应，94%为女性，年龄中位数（范围）46岁（28 - 54岁），症状持续时间12年（5 - 33年）。7名参与者报告PGIC有很大/非常大改善；21名（44%）报告无变化/改善极小。在WPI（-1.9，效应量0.4）、SSS（-1.2，效应量0.6）、疲劳（-0.8，p = 0.014）和体育活动自我效能（1.4，效应量0.4）方面观察到改善。在四个时间点上，WPI、SSS、疼痛和疲劳有显著下降趋势，但在12个月至24个月随访期间无额外改善。完成VTP的参与者从基线到24个月随访期间在症状负担和FM严重程度方面有小到中度改善。试验注册号：ISRCTN96836577 https://doi.org/10.1186/ISRCTN96836577 ，于2016年7月12日前瞻性注册。
