Department of Physical and Rehabilitation Medicine, Kuopio University Hospital, P.O.B 1777 Kuopio, FI-70211, Finland.
BMC Musculoskelet Disord. 2013 Jan 29;14:46. doi: 10.1186/1471-2474-14-46.
Knee osteoarthritis is the most common type of arthritis, with pain being its most common symptom. Little is known about the psychological aspects of knee osteoarthritis pain. There is an emerging consensus among osteoarthritis specialists about the importance of addressing not only biological but also psychosocial factors in the assessment and treatment of osteoarthritis. As few studies have evaluated the effect of psychological interventions on knee osteoarthritis pain, good quality randomized controlled trials are needed to determine their effectiveness.
METHODS/DESIGN: We intend to conduct a 6-week single-blinded randomized controlled trial with a 12-month follow-up. Altogether, 108 patients aged from 35 to 75 years with clinical symptoms and radiographic grading (KL 2-4) of knee osteoarthritis will be included. The clinical inclusion criteria are pain within the last year in or around the knee occurring on most days for at least one month, and knee pain of ≥ 40 mm on a 100-mm visual analogue scale in the WOMAC pain subscale for one week prior to study entry. Patients with any severe psychiatric disorder, other back or lower limb pain symptoms more aggravating than knee pain, or previous or planned lower extremity joint surgery will be excluded. The patients will be randomly assigned to a combined GP care and cognitive-behavioral intervention group (n = 54) or to a GP care control group (n = 54). The cognitive-behavioral intervention will consist of 6 weekly group sessions supervised by a psychologist and a physiotherapist experienced in the treatment of pain. The main goals of the intervention are to reduce maladaptive pain coping and to increase the self-management of pain and disability. The follow-up-points will be arranged at 3 and 12 months. The primary outcome measure will be the WOMAC pain subscale. Secondary outcome measures will include self-reports of pain and physical function, a health related quality of life questionnaire, and various psychological questionnaires. Personnel responsible of the data analysis will be blinded.
This study addresses the current topic of non-pharmacological conservative treatment of knee OA-related pain. We anticipate that these results will provide important new insights to the current care recommendations.
Current Controlled Trials ISRCTN64794760.
膝骨关节炎是最常见的关节炎类型，疼痛是其最常见的症状。对于膝骨关节炎疼痛的心理方面知之甚少。骨关节炎专家越来越一致认为，在评估和治疗骨关节炎时，不仅要考虑生物因素，还要考虑心理社会因素。由于很少有研究评估心理干预对膝骨关节炎疼痛的影响，因此需要高质量的随机对照试验来确定其效果。
方法/设计：我们打算进行一项为期 6 周的单盲随机对照试验，并进行为期 12 个月的随访。总共将纳入 108 名年龄在 35 至 75 岁之间、有临床症状和放射学分级（KL 2-4）的膝骨关节炎患者。临床纳入标准为过去 1 年内膝部或周围疼痛，至少持续 1 个月，每周至少 1 天，WOMAC 疼痛量表中疼痛亚量表的疼痛评分≥40mm，在研究入组前 1 周。有任何严重精神疾病、比膝痛更严重的其他背部或下肢疼痛症状、或以前或计划进行下肢关节手术的患者将被排除。患者将被随机分配到综合初级保健和认知行为干预组（n=54）或初级保健对照组（n=54）。认知行为干预将包括由经验丰富的疼痛治疗心理学家和物理治疗师监督的 6 周小组会议。干预的主要目标是减少适应不良的疼痛应对，增加疼痛和残疾的自我管理。随访点安排在 3 个月和 12 个月。主要结局指标是 WOMAC 疼痛量表。次要结局指标包括疼痛和身体功能的自我报告、健康相关生活质量问卷以及各种心理问卷。负责数据分析的人员将被设盲。
本研究针对的是膝骨关节炎相关疼痛的非药物保守治疗这一当前课题。我们预计这些结果将为当前的护理建议提供重要的新见解。
当前对照试验 ISRCTN64794760。
