Cleland Joshua A, Fritz Julie M, Childs John D, Kulig Kornelia
Department of Physical Therapy, Franklin Pierce College 5 Chenell Drive, Concord, NH 03301, USA.
BMC Musculoskelet Disord. 2006 Feb 10;7:11. doi: 10.1186/1471-2474-7-11.
Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain (LBP) that are likely to benefit from a lumbo-pelvic thrust manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result similar outcomes. The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR.
METHODS/DESIGN: Consecutive patients with LBP referred to physical therapy clinics in one of four geographical locations who satisfy the CPR will be invited to participate in this randomized clinical trial. Subjects who agree to participate will undergo a standard evaluation and complete a number of patient self-report questionnaires including the Oswestry Disability Index (OSW), which will serve as the primary outcome measure. Following the baseline examination patients will be randomly assigned to receive the lumbopelvic manipulation used in the development of the CPR, an alternative lumbar manipulation technique, or non-thrust lumbar mobilization technique for the first 2 visits. Beginning on visit 3, all 3 groups will receive an identical standard exercise program for 3 visits (visits 3,4,5). Outcomes of interest will be captured by a therapist blind to group assignment at 1 week (3rd visit), 4 weeks (6th visit) and at a 6-month follow-up. The primary aim of the study will be tested with analysis of variance (ANOVA) using the change in OSW score from baseline to 4-weeks (OSWBaseline - OSW4-weeks) as the dependent variable. The independent variable will be treatment with three levels (lumbo-pelvic manipulation, alternative lumbar manipulation, lumbar mobilization).
This trial will be the first to investigate the effectiveness of various manual therapy techniques for patients with LBP who satisfy a CPR.
最近已开发并验证了一种临床预测规则（CPR），该规则可准确识别可能从腰骶部推力手法治疗中获益的腰痛（LBP）患者。制定和验证该规则的研究使用了相同的手法治疗程序。然而，最近的证据表明，不同的手法治疗技术可能会产生相似的结果。本研究的目的是调查三种不同手法治疗技术在符合CPR的腰痛患者亚组中的有效性。
方法/设计：连续的符合CPR的腰痛患者被转介到四个地理位置之一的物理治疗诊所，将被邀请参加这项随机临床试验。同意参与的受试者将接受标准评估并完成多项患者自我报告问卷，包括Oswestry功能障碍指数（OSW），该指数将作为主要结局指标。在基线检查后，患者将被随机分配接受CPR开发中使用的腰骶部手法治疗、另一种腰椎手法治疗技术或非推力腰椎松动技术，为期前2次就诊。从第3次就诊开始，所有3组患者将接受相同的标准运动计划，为期3次就诊（第3、4、5次就诊）。感兴趣的结局将由对分组情况不知情的治疗师在1周（第3次就诊）、4周（第6次就诊）和6个月随访时记录。本研究的主要目的将通过方差分析（ANOVA）进行检验，以OSW评分从基线到4周的变化（OSW基线 - OSW4周）作为因变量。自变量将是具有三个水平的治疗（腰骶部手法治疗、另一种腰椎手法治疗、腰椎松动）。
这项试验将是首次调查各种手法治疗技术对符合CPR的腰痛患者有效性的研究。
