Research Department, Spine Centre of Southern Denmark, Hospital Lillebaelt, Middelfart, Denmark.
BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22.
Clinical experience suggests that many patients with Modic changes have relatively severe and persistent low back pain (LBP), which typically appears to be resistant to treatment. Exercise therapy is the recommended treatment for chronic LBP, however, due to their underlying pathology, Modic changes might be a diagnostic subgroup that does not benefit from exercise. The objective of this study was to compare the current state-of-the art treatment approach (exercise and staying active) with a new approach (load reduction and daily rest) for people with Modic changes using a randomized controlled trial design.
Participants were patients from an outpatient clinic with persistent LBP and Modic changes. They were allocated using minimization to either rest therapy for 10 weeks with a recommendation to rest for two hours daily and the option of using a flexible lumbar belt or exercise therapy once a week for 10 weeks. Follow-up was at 10 weeks after recruitment and 52 weeks after intervention and the clinical outcome measures were pain, disability, general health and global assessment, supplemented by weekly information on low back problems and sick leave measured by short text message (SMS) tracking.
In total, 100 patients were included in the study. Data on 87 patients at 10 weeks and 96 patients at one-year follow-up were available and were used in the intention-to-treat analysis. No statistically significant differences were found between the two intervention groups on any outcome.
No differences were found between the two treatment approaches, 'rest and reduced load' and 'exercise and staying active', in patients with persistent LBP and Modic changes.
ClinicalTrials.gov: NCT00454792.
临床经验表明，许多患有 Modic 改变的患者都有相对严重和持续的下腰痛（LBP），且这种疼痛通常似乎对治疗有抗性。运动疗法是治疗慢性 LBP 的推荐疗法，然而，由于其潜在的病理，Modic 改变可能是一个诊断亚组，其不能从运动中获益。本研究的目的是使用随机对照试验设计，比较目前的最先进治疗方法（运动和保持活跃）与新方法（减少负荷和日常休息）对患有 Modic 改变的患者的治疗效果。
参与者为来自门诊的持续性 LBP 和 Modic 改变患者。他们使用最小化分配方法分为休息治疗组（10 周，每天建议休息 2 小时，并可选择使用灵活的腰部支撑带）或运动治疗组（每周一次，共 10 周）。随访时间为招募后的 10 周和干预后的 52 周，临床结局指标包括疼痛、残疾、一般健康和总体评估，辅以每周通过短文本消息（SMS）跟踪记录下腰痛问题和病假情况。
共有 100 名患者入组本研究。10 周时可获得 87 名患者的数据，1 年随访时可获得 96 名患者的数据，且均用于意向治疗分析。在任何结局指标上，两组干预之间均未发现统计学差异。
在持续性 LBP 和 Modic 改变患者中，“休息和减少负荷”与“运动和保持活跃”两种治疗方法之间未发现差异。
ClinicalTrials.gov：NCT00454792。
