University of Iowa, Iowa City, IA, USA.
Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.
Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment.
METHODS/DESIGN: A total of 219 participants with acute, subacute or chronic low back pain are being recruited from the Quad Cities area located in Iowa and Illinois. They are allocated through a minimization algorithm in a 1:1:1 ratio to receive either 13 HVLA-SM treatments over 6 weeks, 13 LVVA-SM treatments over 6 weeks or 2 weeks of a sham treatment followed by 4 weeks of full spine "doctor's choice" SM. Sensorimotor function tests are performed before and immediately after treatment at baseline, week 2 and week 6. Self-report outcome assessments are also collected. The primary aims of this study are to 1) determine immediate pre to post changes in sensorimotor function as measured by postural sway following delivery of a single HVLA-SM or LVVA-SM treatment when compared to a sham treatment and 2) to determine changes from baseline to 2 weeks (4 treatments) of HVLA-SM or LVVA-SM compared to a sham treatment. Secondary aims include changes in response to sudden loads and lumbar repositioning accuracy at these endpoints, estimating sensorimotor function in the SM groups after 6 weeks of treatment, and exploring if changes in sensorimotor function are associated with changes in self-report outcome assessments.
This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM.
This trial is registered in ClinicalTrials.gov, with the ID number of NCT00830596, registered on January 27, 2009. The first participant was allocated on 30 January 2009 and the final participant was allocated on 17 March 2011.
下背痛（LBP）是一个公认的公共卫生问题，影响高达 80%的美国成年人在他们的生活中的某个时刻。患有 LBP 的患者正在利用整体健康护理，如脊柱推拿（SM）。SM 是对特定身体组织或结构的负荷的治疗应用，可以分为两类：高速度低幅度负荷的 SM，或脉冲“推力”（HVLA-SM）和低速度可变幅度负荷的 SM（LVVA-SM）。有证据表明，LBP 患者的感觉运动功能发生了改变。本研究通过姿势摆动、对突然负荷的反应和重新定位准确性来评估腰椎骨盆区域的感觉运动功能，与假治疗相比，SM 治疗腰椎和骨盆区域后。
方法/设计：共有 219 名急性、亚急性或慢性下背痛患者从位于爱荷华州和伊利诺伊州的 Quad Cities 地区招募。他们通过最小化算法以 1:1:1 的比例分配，以接受 13 次 HVLA-SM 治疗 6 周、13 次 LVVA-SM 治疗 6 周或 2 周的假治疗，然后接受 4 周的全脊柱“医生选择”SM。在基线、第 2 周和第 6 周进行治疗前和治疗后即刻进行感觉运动功能测试。还收集自我报告的结果评估。本研究的主要目的是 1）确定单次 HVLA-SM 或 LVVA-SM 治疗与假治疗相比，治疗后姿势摆动测量的感觉运动功能的即刻预治疗后变化，2）确定与假治疗相比，HVLA-SM 或 LVVA-SM 从基线到 2 周（4 次治疗）的变化。次要目标包括在这些终点时对突然负荷和腰椎重新定位准确性的反应变化，估计治疗 6 周后的 SM 组的感觉运动功能，并探讨感觉运动功能的变化是否与自我报告结果评估的变化相关。
本研究可能为解释与 LBP 相关的功能缺陷的感觉运动机制以及 SM 的作用机制提供线索。
本试验在 ClinicalTrials.gov 注册，注册号为 NCT00830596，于 2009 年 1 月 27 日注册。第一个参与者于 2009 年 1 月 30 日分配，最后一个参与者于 2011 年 3 月 17 日分配。
