Department of Rheumatology, Glostrup University Hospital, Glostrup, Denmark.
Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76. doi: 10.1097/BRS.0b013e3181b8db2e.
STUDY DESIGN: A stratified randomized single-blinded clinical trial. OBJECTIVE: To compare the efficacies of 2 active therapies for chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Both a multidisciplinary biopsychosocial rehabilitation program and an intensive individual therapist-assisted back muscle strengthening exercise program used in Denmark have been reported to be effective for the treatment of CLBP. METHODS: A total of 286 patients with CLBP were randomized to either a group-based 12-week program comprising 73 hours of therapist exposure (approximately 12 h/patient): 35 hours of hard physical exercise, 22 hours of light exercise/occupational therapy, and 16 hours of education (group A) or a 12-week program comprising 1 hour of personal training twice a week, i.e., therapist exposure 24 h/patient (group B). At baseline and at 3, 6, 12, and 24 months, patients filled out questionnaires on pain (visual analogue scale [VAS]-pain average, which was the primary outcome measure), Roland-Morris disability questionnaire, global perceived outcome, and 36-Item Short-Form General Health Survey. Data were analyzed using the intention-to-treat principle. RESULTS: Of the 286 patients, 14 patients did not start treatment. Of the remaining patients, 25 (9%) dropped out of therapy. The 2 groups were comparable regarding baseline characteristic. After treatment, significant improvements were observed with regard to pain, disability, and most of the quality of life dimensions. These effects were sustained over the 24-month follow-up period. There were some statistically significant differences between the 2 groups relating to secondary end points, Roland-Morris disability questionnaire, and in the MOS 36-Item Short-Form Health Survey the "physical functioning" dimension and the "physical component summary." CONCLUSION: Both groups showed long-term improvements in pain and disability scores, with only minor statistically significant differences between the 2 groups. The minor outcome difference in favor of the group-based multidisciplinary rehabilitation program is hardly of clinical interest for individual patients.
研究设计：分层随机单盲临床试验。 研究目的：比较两种慢性下背痛（CLBP）主动治疗的疗效。 背景数据摘要：丹麦报道的多学科生物心理社会康复计划和密集的个体治疗师辅助背部肌肉强化锻炼计划都对治疗 CLBP 有效。 方法：共有 286 例 CLBP 患者随机分为组间 12 周方案，包括 73 小时治疗师暴露（约 12 小时/患者）：35 小时剧烈体力活动、22 小时轻度运动/职业治疗和 16 小时教育（A 组）或 12 周方案包括每周两次 1 小时个人培训，即治疗师暴露 24 小时/患者（B 组）。在基线和 3、6、12 和 24 个月时，患者填写疼痛问卷（视觉模拟量表[VAS]-疼痛平均，这是主要结局指标）、Roland-Morris 残疾问卷、总体感知结果和 36-项简明健康调查。使用意向治疗原则进行数据分析。 结果：286 例患者中，14 例未开始治疗。在其余患者中，25 例（9%）退出治疗。两组基线特征具有可比性。治疗后，疼痛、残疾和大多数生活质量维度均有显著改善。这些效果在 24 个月的随访期间得以维持。两组之间在次要终点、Roland-Morris 残疾问卷以及 MOS 36-项简明健康调查中的“身体机能”维度和“身体成分综合评分”方面存在一些统计学上的显著差异。 结论：两组患者疼痛和残疾评分均有长期改善，两组之间仅存在微小的统计学差异。组间多学科康复计划的轻微结果差异对个体患者几乎没有临床意义。
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