Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands.
Spine (Phila Pa 1976). 2012 Jul 15;37(16):1347-56. doi: 10.1097/BRS.0b013e31824d9f2b.
A randomized controlled trial.
To assess the effectiveness of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with subacute or chronic low back pain.
No trial has evaluated this approach in patients with subacute and chronic low back pain.
Before randomization, all patients were classified by research physical therapists according to a modified version of Delitto's classification-based system. Randomization was computer-generated, with centralized allocation concealment. The statistician and the physical therapists were unblinded. Patients and assistants who collected follow-up questionnaires were blinded. Follow-up assessments were completed at 8, 26, and 52 weeks. The primary analysis was performed according to the intention-to-treat principle, using multilevel analysis. The main outcomes were global perceived effect, disability (Oswestry Disability Index, 0-100), and pain intensity (Numerical Rating Scale, 0-10). Secondary outcomes were quality of life, fear-avoidance beliefs, and psychosocial status. RESULTS.: A total of 156 patients were included (classification-based group, n = 74; usual physical therapy group, n = 82). There were no statistically significant differences between the treatment groups for any of the outcomes at any of the follow-up time points. After 8 weeks, patients in the classification-based group had greater global perceived effect scores; adjusted odds ratio of 1.01 (95% confidence interval [CI], 0.31 to 3.28), and higher adjusted Oswestry Disability Index and Numerical Rating Scale scores; mean adjusted differences of 0.48 points (95% CI, -4.59 to 3.63) and 0.49 points (95% CI, -1.34 to 0.37) respectively, but all differences were statistically nonsignificant.
The classification-based system used in this study was not effective for improving physical therapy care outcomes in a population of patients with subacute and chronic low back pain.
一项随机对照试验。
评估 Delitto 分类治疗方法与常规物理治疗在亚急性或慢性下背痛患者中的疗效。
尚无试验评估该方法在亚急性和慢性下背痛患者中的疗效。
所有患者在随机分组前均由研究物理治疗师根据改良版 Delitto 分类治疗系统进行分类。采用中央随机化分配方法进行分组，且对统计师和物理治疗师均设盲。收集随访问卷的患者和助手设盲。8 周、26 周和 52 周时进行随访评估。主要分析采用意向治疗原则进行多级分析。主要结局为整体感知疗效、残疾（Oswestry 残疾指数，0-100）和疼痛强度（数字评分量表，0-10）。次要结局为生活质量、恐惧回避信念和心理社会状况。结果：共纳入 156 例患者（分类治疗组 74 例，常规物理治疗组 82 例）。在任何随访时间点，两组间各结局均无统计学差异。8 周时，分类治疗组患者的整体感知疗效评分更高；校正比值比为 1.01（95%置信区间[CI]，0.31 至 3.28），且 Oswestry 残疾指数和数字评分量表评分也更高；校正平均差异分别为 0.48 分（95%CI，-4.59 至 3.63）和 0.49 分（95%CI，-1.34 至 0.37），但所有差异均无统计学意义。
本研究中使用的分类系统对改善亚急性和慢性下背痛患者的物理治疗效果无效。
