Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Oslo, Norway
Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.
BMJ Open. 2021 Jun 29;11(6):e046943. doi: 10.1136/bmjopen-2020-046943.
Non-pharmacological approaches are recommended as first-line treatment for patients with fibromyalgia. This randomised controlled trial investigated the effects of a multicomponent rehabilitation programme for patients with recently diagnosed fibromyalgia in primary and secondary healthcare.
Patients with widespread pain ≥3 months were referred to rheumatologists for diagnostic clarification and assessment of study eligibility. Inclusion criteria were age 20-50 years, engaged in work or studies at present or during the past 2 years, and fibromyalgia diagnosed according to the American College of Rheumatology 2010 criteria. All eligible patients participated in a short patient education programme before inclusion and randomisation. The multicomponent programme, a 10-session mindfulness-based and acceptance-based group programme followed by 12 weeks of physical activity counselling was evaluated in comparison with treatment as usual, that is, no treatment or any other treatment of their choice. The primary outcome was the Patient Global Impression of Change (PGIC). Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life and work ability at 12-month follow-up.
In total, 170 patients were randomised, 1:1, intervention:control. Overall, the multicomponent rehabilitation programme was not more effective than treatment as usual; 13% in the intervention group and 8% in the control group reported clinically relevant improvement in PGIC (p=0.28). No statistically significant between-group differences were found in any disease-related secondary outcomes. There were significant between-group differences in patient's tendency to be mindful (p=0.016) and perceived benefits of exercise (p=0.033) in favour of the intervention group.
A multicomponent rehabilitation programme combining patient education with a mindfulness-based and acceptance-based group programme followed by physical activity counselling was not more effective than patient education and treatment as usual for patients with recently diagnosed fibromyalgia at 12-month follow-up.
BMC Registry (ISRCTN96836577).
非药物方法被推荐为纤维肌痛患者的一线治疗方法。这项随机对照试验研究了多组分康复方案对初级和二级保健中近期诊断为纤维肌痛患者的影响。
广泛性疼痛≥3 个月的患者被转诊给风湿病医生进行诊断澄清和研究资格评估。纳入标准为年龄 20-50 岁，目前或过去 2 年内从事工作或学习，根据美国风湿病学院 2010 标准诊断为纤维肌痛。所有符合条件的患者在纳入和随机分组前均参加了简短的患者教育计划。多组分方案，即 10 节基于正念和接受的小组方案，随后进行 12 周的身体活动咨询，与常规治疗（即无治疗或任何其他选择的治疗）进行比较。主要结局是患者总体印象变化（PGIC）。次要结局是自我报告的疼痛、疲劳、睡眠质量、心理困扰、身体活动、健康相关生活质量和工作能力，随访 12 个月。
共有 170 名患者随机分组，1:1，干预组：对照组。总体而言，多组分康复方案并不优于常规治疗；干预组 13%和对照组 8%的患者报告 PGIC 有临床相关改善（p=0.28）。在任何与疾病相关的次要结局中，两组之间均未发现统计学显著差异。在患者倾向于保持正念（p=0.016）和感知运动益处（p=0.033）方面，干预组有显著的组间差异。
在 12 个月随访时，将患者教育与基于正念和接受的小组方案相结合，随后进行身体活动咨询的多组分康复方案并不优于患者教育和常规治疗，对近期诊断为纤维肌痛的患者有效。
BMC 注册（ISRCTN96836577）。
