Dosing Study of Massage for Neck Pain

描述(申请人提供)：这项研究的长期目标是确定治疗颈部疼痛的有效方法。许多美国人发现，传统的医疗疗法对这种常见且昂贵的问题无效，他们越来越多地尝试补充和替代疗法，包括治疗性按摩。尽管按摩越来越受欢迎，但其治疗颈部疼痛的有效性仍不清楚，主要是因为这一领域的研究质量较差。以前研究的一个主要缺陷是他们使用了按摩治疗师认为不够充分的“低剂量”按摩。不幸的是，每次按摩的分钟数，每周的按摩次数，或按摩所需的几周治疗，才能产生有益或最佳的效果，目前尚不清楚。这项研究旨在解决我们知识中的这些差距，为慢性颈部疼痛患者确定：1)每周治疗次数和单独治疗时间的最佳组合，以及2)最佳治疗周数。在这个项目中，228名患有慢性非特异性颈部疼痛的患者将被随机分成等待名单对照组或接受5种不同剂量组合中的一种的4周治疗(每周2或3次30分钟的治疗或每周1、2或3次60分钟的治疗)。在为期4周的初级治疗期结束时，最初接受5种剂量组合的参与者将被随机分配到次级治疗期，要么不进行额外治疗，要么每周进行6次60分钟的按摩。主要结果，颈部相关功能障碍和疼痛，将在随机化后4、10和26周由盲人电话采访者进行评估。为了更好地描述治疗效果持续的轨迹，这些访谈数据将补充通过邮寄问卷在8、14、18和39周收集的结果数据。在初级治疗期间对6组的结果进行比较将确定最佳每周剂量，而在第二次治疗期间的结果比较将确定10周治疗是否优于4周。这项研究的结果将：1)指导按摩治疗方案的发展，以用于全面评估治疗颈部疼痛的有效性；2)作为未来按摩和身体部位剂量研究的模型；以及3)帮助解释过去颈部疼痛按摩研究中使用的按摩剂量的充分性。公共卫生相关性：治疗性按摩是治疗颈部疼痛的常用方法，但其有效性尚不清楚。这项研究旨在找出治疗慢性颈部疼痛的最佳按摩剂量，以便未来的临床试验可以包括被认为是最佳剂量的按摩。

DESCRIPTION (provided by applicant): This study's long-term objective is to identify effective treatments for with neck pain. Many Americans have found conventional medical treatments ineffective for this common and costly problem and are increasingly trying complementary and alternative treatments, including therapeutic massage. Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research in this area. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the numbers of minutes per massage session, sessions per weeks, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. In this project, 228 persons with chronic non-specific neck pain will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-minute treatments per week or 1, 2, or 3 60-minute treatments per week). At the end of this 4 week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-minute massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 4, 10, and 26 weeks post-randomization. To better characterize the trajectory of the persistence of treatment effects, these interview data will be supplemented with outcomes data collected by mailed questionnaire at 8, 14, 18 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. The results of this study will: 1) guide the development of a massage treatment protocol to be used in a full-scale trial evaluating the effectiveness of therapeutic massage for chronic neck pain, 2) serve as a model for future dosing studies of massage and bodywork, and 3) help interpret the adequacy of the dosing of massage used in past studies of massage for neck pain. PUBLIC HEALTH RELEVANCE: Therapeutic massage is a commonly used treatment for neck pain, but its effectiveness is unknown. This study is designed to find out what the best dose of massage for chronic neck pain is so that future clinical trials can include a dose that would be considered optimal.