University of Puget Sound, School of Physical Therapy, Tacoma, WA, USA.
J Orthop Sports Phys Ther. 2010 Mar;40(3):133-40. doi: 10.2519/jospt.2010.3106.
Secondary analysis of a randomized clinical trial (RCT).
To perform a secondary analysis on the treatment arm of a larger RCT to determine differences in treatment outcomes, adverse reactions, and effect sizes between patients who received cervical thrust manipulation and those who received only nonthrust manipulation as part of an impairment-based, multimodal treatment program of manual physical therapy (MPT) and exercise for patients with mechanical neck pain.
A treatment regimen of MPT and exercise has been effective in patients with mechanical neck pain. Limited research has compared the effectiveness of cervical thrust manipulations and nonthrust mobilizations for this patient population, and no studies have investigated the added benefit of cervical thrust manipulations as part of an overall MPT treatment plan.
Treatment outcomes from 47 patients in the treatment arm of a larger RCT, with a primary complaint of mechanical neck pain, were analyzed. Twenty-three patients (49%) received cervical thrust manipulations as part of their MPT treatment, and 24 patients (51%) received only cervical nonthrust mobilizations. All patients received up to 6 clinic sessions, twice weekly for 3 weeks, and a home exercise program. Primary outcome measures were the Neck Disability Index (NDI), 2 visual analog scales for cervical and upper extremity pain, and a 15-point global rating of change scale. Blinded outcome measurements were collected at baseline and at 3-, 6- and 52-week follow-ups.
Consistent with the larger RCT, both subgroups in this secondary analysis demonstrated improvement in short- and long-term pain and disability scores. Low statistical power (beta< or =.28) and the resultant small effect size indices (-0.21 to 0.17) preclude the identification of any between-group differences. No serious adverse reactions were reported by patients in either subgroup.
Clinically meaningful and statistically significant improvements in both subgroups of patients over time suggest that cervical thrust manipulation, as part of the MPT treatment plan, did not influence the results of the treatment arm of the larger RCT from which this study was drawn. Although no between-group differences can be identified, the small observed effect sizes in this study may benefit future studies with sample size estimation for larger RCTs and indicate the need to incorporate clinical prediction rule criteria as a means to improve statistical power.
Therapy, level 4.
随机临床试验(RCT)的二次分析。
对更大 RCT 的治疗臂进行二次分析,以确定接受颈椎推扳手法治疗和仅接受非推扳手法治疗的患者之间的治疗结果、不良反应和效应大小的差异,这些患者是作为基于损伤的多模式治疗计划(包括手动物理治疗(MPT)和运动)的一部分接受治疗的机械性颈痛患者。
MPT 和运动的治疗方案对机械性颈痛患者有效。有限的研究比较了颈椎推扳手法和非推扳手法对这类患者人群的有效性,也没有研究调查颈椎推扳手法作为整体 MPT 治疗计划的一部分的额外益处。
分析了来自更大 RCT 的治疗臂的 47 名患者的治疗结果,这些患者的主要抱怨是机械性颈痛。23 名患者(49%)接受颈椎推扳手法作为 MPT 治疗的一部分,24 名患者(51%)仅接受颈椎非推扳手法治疗。所有患者接受了最多 6 次的诊所治疗,每周 2 次,持续 3 周,以及家庭运动计划。主要结局指标是颈部残疾指数(NDI)、颈部和上肢疼痛的 2 个视觉模拟量表,以及 15 分的整体变化评分。在基线、3、6 和 52 周随访时进行盲法结局测量。
与更大 RCT 一致,这一二次分析的两个亚组都表现出短期和长期疼痛和残疾评分的改善。低统计能力(β<或=.28)和由此产生的小效应大小指数(-0.21 至 0.17)排除了任何组间差异的识别。两个亚组的患者都没有报告严重的不良反应。
随着时间的推移,两个患者亚组的临床意义和统计学意义上的显著改善表明,颈椎推扳手法作为 MPT 治疗计划的一部分,并没有影响从该研究中得出的更大 RCT 的治疗臂的结果。虽然无法识别出组间差异,但本研究中观察到的小效应大小可能有益于未来的研究,这些研究需要进行样本量估计以进行更大的 RCT,并表明需要纳入临床预测规则标准作为提高统计能力的一种手段。
治疗,4 级。