Evaluating Therapeutic Massage for Chronic Neck Pain

描述(由申请人提供)：颈部疼痛是影响美国人健康的最常见问题之一，也是使用补充或替代医学(CAM)疗法的主要原因。治疗性按摩是治疗颈部疼痛最常用的CAM疗法之一，但人们对其有效性知之甚少。这项研究将为评估推拿治疗慢性颈痛的有效性的全面试验奠定基础。在这个项目的第一阶段，我们将为这样的随机临床试验开发和预测试关键组件。这将包括按摩组和对照组的方案规范，制定明确和一致地描述本研究中使用的按摩技术的分类法，以及指定受试者选择标准。在第二阶段，我们将使用在第一阶段开发的研究组件来进行一项试点试验，评估按摩治疗慢性颈痛的有效性和安全性。我们将随机选择60名慢性颈痛患者接受治疗性按摩(n=30)或最低限度的自我护理干预(n=30)。我们将通过比较两组在治疗中途、治疗结束时和6个月时与背部疼痛相关的提供者就诊的症状、功能、生活质量和费用的变化来评估按摩的效果。试点研究将使我们能够识别和解决研究设计、结果测量和治疗方案方面的意想不到的问题；估计足够强大的全面试验所需的样本量；确定所需的相应招募时间；以及获得对按摩治疗慢性颈部疼痛的有效性和安全性的初步估计。在这个项目结束时，我们将准备一份竞争性的赠款提案，以进行一项全面的试验，评估按摩作为慢性颈部疼痛患者的治疗效果。

DESCRIPTION (provided by applicant): Neck pain is one of the most common problems affecting the health of Americans and is a leading reason for using complementary or alternative medical (CAM) therapies. Therapeutic massage is one of the most popular CAM treatments for neck pain, but little is known about its effectiveness. This study will lay the groundwork for a full-scale trial that evaluates the effectiveness of therapeutic massage for chronic neck pain. During Phase I of this project, we will develop and pre-test key components for such a randomized clinical trial. This will include specification of protocols in the massage and the comparison groups, development of a taxonomy that clearly and consistently describes the massage techniques used in this study, and specification of subject selection criteria. During Phase II, we will use the study components developed during Phase I to conduct a pilot trial evaluating the effectiveness and safety of massage for chronic neck pain. We will randomize 60 persons with chronic neck pain to therapeutic massage (n=30) or to a minimal self-care intervention (n=30). We will evaluate the effect of massage by comparing changes in symptoms, function, quality of life, and costs of back pain-related provider visits in these two groups midway through treatment, at the end of treatment, and at 6 months. The pilot study will permit us to identify and resolve unanticipated problems with the study design, outcomes measures, and treatment protocols; to estimate the samples sizes required for an adequately powered full-scale trial; to determine the corresponding recruitment period that would be required; and to obtain preliminary estimates of the effectiveness and safety of massage for chronic neck pain. At the conclusion of this project, we will be well-positioned to prepare a competitive grant proposal for a full-scale trial that evaluates the effectiveness of massage as a treatment for persons with chronic neck pain.