George Steven Z, Childs John D, Teyhen Deydre S, Wu Samuel S, Wright Alison C, Dugan Jessica L, Robinson Michael E
Department of Physical Therapy, Brooks Center for Rehabilitation Studies, PO Box 100154, University of Florida, Gainesville, FL 32610-0154, USA.
BMC Musculoskelet Disord. 2007 Sep 14;8:92. doi: 10.1186/1471-2474-8-92.
There are few effective strategies reported for the primary prevention of low back pain (LBP). Core stabilization exercises targeting the deep abdominal and trunk musculature and psychosocial education programs addressing patient beliefs and coping styles represent the current best evidence for secondary prevention of low back pain. However, these programs have not been widely tested to determine if they are effective at preventing the primary onset and/or severity of LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core stabilization exercise and education program is effective in preventing the onset and/or severity of LBP. The effect of the combined program will be compared to three other standard programs.
METHODS/DESIGN: Consecutive Soldiers participating in advanced individual training (AIT) will be screened for eligibility requirements and consented to study participation, as appropriate. Companies of Soldiers will be randomly assigned to receive the following standard prevention programs; a core stabilization exercise program (CSEP) alone, a CSEP with a psychosocial education (PSEP), a traditional exercise (TEP), or a TEP with a PSEP. Proximal outcome measures will be assessed at the conclusion of AIT (a 12 week training period) and include imaging of deep lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness of selected deep lumbar musculature (transversus abdominus, multifidi, and erector spinae muscles). We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal outcomes of LBP occurrence and severity. This information will be collected during the subsequent 2 years following completion of AIT using a web-based data entry system. Soldiers will receive a monthly email that queries whether any LBP was experienced in the previous calendar month. Soldiers reporting LBP will enter episode-specific data related to pain intensity, pain-related disability, fear-avoidance beliefs, and pain catastrophizing. We are hypothesizing that Soldiers receiving the CSEP and PSEP will report the longest duration to first episode of LBP, the lowest frequency of LBP, and the lowest severity of LBP episodes. Statistical comparisons will be made between each of the randomly assigned prevention programs to test our hypotheses related to determining which of the 4 programs is most effective.
We have presented the design and protocol for the POLM trial. Completion of this trial will provide important information on how to effectively train Soldiers for the prevention of LBP.
目前报道的用于腰痛（LBP）一级预防的有效策略较少。针对腹部深层和躯干肌肉组织的核心稳定性训练以及针对患者信念和应对方式的心理社会教育项目是目前腰痛二级预防的最佳证据。然而，这些项目尚未得到广泛测试，以确定它们是否能有效预防腰痛的初次发作和/或严重程度。这项整群随机临床试验的目的是确定核心稳定性训练与教育相结合的项目是否能有效预防腰痛的发作和/或严重程度。将该联合项目的效果与其他三个标准项目进行比较。
方法/设计：对参加高级单兵训练（AIT）的连续士兵进行资格要求筛查，并在适当时征得其同意参与研究。士兵连队将被随机分配接受以下标准预防项目：单独的核心稳定性训练项目（CSEP）、包含心理社会教育的CSEP（PSEP）、传统训练项目（TEP）或包含PSEP的TEP。近端结局指标将在AIT结束时（为期12周的训练期）进行评估，包括使用实时超声成像对腰椎深层肌肉进行成像，以及通过自我报告问卷了解对腰痛的信念。我们假设接受CSEP的士兵所选腰椎深层肌肉（腹横肌、多裂肌和竖脊肌）的厚度会增加。我们还假设接受PSEP的士兵对腰痛管理的信念会得到改善。AIT结束后，每月对士兵进行随访，以测量腰痛发生和严重程度的远端结局。这些信息将在AIT完成后的后续2年中使用基于网络的数据录入系统收集。士兵每月会收到一封电子邮件，询问在前一个日历月是否经历过腰痛。报告有腰痛的士兵将输入与疼痛强度、疼痛相关残疾、恐惧回避信念和疼痛灾难化相关的特定发作数据。我们假设接受CSEP和PSEP的士兵首次出现腰痛的持续时间最长、腰痛频率最低且腰痛发作的严重程度最低。将对每个随机分配的预防项目进行统计比较，以检验我们关于确定这4个项目中哪个最有效的假设。
我们介绍了POLM试验的设计和方案。该试验的完成将为如何有效训练士兵预防腰痛提供重要信息。
