Validation of a novel sham cervical manipulation procedure.
Validation of a novel sham cervical manipulation procedure.
复制标题
DOI：
10.1016/j.spinee.2012.10.009
复制
发表时间：
2012-11
期刊：
影响因子：
--
通讯作者：
Dinulos MD
中科院分区：
文献类型：
--
作者：
Vernon HT;Triano JJ;Ross JK;Tran SK;Soave DM;Dinulos MD
对于慢性颈痛的脊柱推拿治疗，无论是单次还是多次干预，都没有采用有效的假推拿对照组。采用一种实用的假颈椎高速低幅度（HVLA）脊柱手法。在机构临床研究实验室中进行的随机、实验验证研究合格的受试者为男性和女性，年龄为18-60岁，患有持续时间至少3个月的机械性颈部疼痛（由国际疼痛分类研究协会定义）。排除手臂疼痛、颈部疼痛的任何病理原因或脊柱操作的任何禁忌症的受试者。主要结局是患者的自我报告或治疗后分组的“登记”。次要结局为NRS-101颈部疼痛、活动度（通过测角器）、压痛（通过压力痛觉测定法）。符合条件的受试者被随机分配到两组之一：“真实的”或假颈椎手法（RM或SM）。所有受试者依次接受两种手术，RM+SM或SM+SM。两次手术后，立即要求受试者记录手术期间发生的任何疼痛，并确定其治疗组分配。在所有手术过程中记录力-时间曲线。在基线、干预后5分钟和15分钟获得次要临床结局指标，包括活动范围、疼痛自我报告和局部棘突压痛。对每个变量的数据进行总结，并检验分布的正态性。获得每个变量的汇总统计量，并进行统计学检验。这项研究的资金来自美国国立卫生研究院（NCCAM：R21 AT 004396 - 01 A1）和加拿大卫生研究院（BMT 91926）。本研究中不存在利益冲突。67例受试者接受了随机化。64例受试者（每组32例）的数据可用于分析。基线时两组之间无显著差异。“真实的”组中发生了1起不良事件，为持续< 24小时的轻度治疗后疼痛反应。在RM组中，50%的受试者错误地登记了他们的治疗分配;在假手术组中，53%的受试者这样做。对于SM组，没有手术导致空化，而在RM组中，87%的手术导致空化。两组之间在疼痛、压痛或ROM方面没有显著变化。RM和SM程序的力-时间曲线显示了保真度，组件之间存在预期的显著差异。新的假手术已被证明可有效地将受试者掩蔽到组分配中，并且在治疗后即刻阶段对常见结局具有临床惰性。进一步研究串行应用程序和多个运营商是必要的。
No clinical trial of spinal manipulation for chronic neck pain, either for single or multiple intervention session(s), has employed an effective sham-manipulation control group. Validate a practical sham cervical high velocity, low amplitude (HVLA) spinal manipulation. Randomized, experimental validation study in an institutional clinical research laboratory Eligible subjects were males and females, 18–60 years of age with mechanical neck pain (as defined by the International Association for the Study of Pain Classification) of at least 3 months duration. Subjects with arm pain, any pathologic cause of neck pain or any contra-indication to spinal manipulation were excluded. The primary outcome was the patient’s self-report or “registration” of group allocation following treatment. Secondary outcomes were NRS-101 for neck pain, range of motion (by goniometer), tenderness (by pressure algometry). Eligible subjects were randomly allocated to one of two groups: “real” or sham cervical manipulation (RM or SM). All subjects were given two procedures in sequence, either RM+SM or SM+SM. Immediately following the two procedures, subjects were asked to register any pain experienced during the procedures and to identify their treatment group allocation. Force-time profiles were recorded during all procedures. Secondary clinical outcome measures were obtained at baseline, 5 and 15 minutes after the intervention including range of motion, self-report of pain and local spinous process tenderness. Data for each variable were summarized and tested for normality in distribution. Summary statistics were obtained for each variable and statistically tested. Funding for this study was obtained from the National Institutes of Health (NCCAM: R21 AT004396-01A1) and the Canadian Institutes of Health Research (BMT91926). No conflicts of interest exist in this study. Sixty-seven subjects were randomized. Data from 64 subjects (32 per group) were available for analysis. There were no significant differences between the groups at baseline. One adverse event occurred in the “real” group which was a mild post- treatment pain reaction lasting < 24 hours. In the RM group, 50% of subjects incorrectly registered their treatment allocation; in the sham group, 53% did so. For the SM group, none of the procedures resulted in cavitation while in the RM group, 87% of procedures resulted in cavitation. There were no significant changes between groups on pain, tenderness or ROM. Force-time profiles of the RM and SM procedures demonstrated fidelity with significant differences between components as intended. The novel sham procedure has been shown to be effective in masking subjects to group allocation and to be clinically inert with respect to common outcomes in the immediate post-treatment stage. Further research on serial applications and for multiple operators is warranted.
登录
查看更多内容
影响因子：
3
作者：
Holm, Lena W.;Carroll, Linda J.;Haldeman, Scott
通讯作者：
Haldeman, Scott
DOI：
10.1016/j.cct.2003.10.016
发表时间：
2004-04-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Bang, HJ;Ni, LY;Davis, CE
通讯作者：
Davis, CE
DOI：
10.1016/s0161-4754(99)70031-x
发表时间：
1999-09-01
影响因子：
1.3
作者：
Hawk, C;Azad, A;Long, CR
通讯作者：
Long, CR
影响因子：
3
作者：
Daffner, SD;Hilibrand, AS;Albert, TJ
通讯作者：
Albert, TJ
影响因子：
3
作者：
GORE, DR;SEPIC, SB;MURRAY, MP
通讯作者：
MURRAY, MP