Dosing Study of Massage for Neck Pain

描述（由申请人提供）：本研究的长期目标是确定颈部疼痛的有效治疗方法。许多美国人发现，对于这种常见且昂贵的问题，传统的医学治疗无效，因此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，主要是因为该领域的研究质量较差。先前研究的一个主要缺陷是他们使用的按摩“剂量”低，按摩治疗师认为这是不够的。不幸的是，每次按摩的分钟数，每周的按摩次数，或每周按摩所需的有益或最佳效果尚不清楚。本研究旨在通过确定慢性颈部疼痛患者：1)每周治疗次数和个体治疗时间的最佳组合，以及2)治疗的最佳周数，来解决我们知识上的这些空白。在这个项目中，228名慢性非特异性颈部疼痛患者将被随机分配到等待名单对照组或接受5种不同剂量组合（每周2或3次30分钟治疗或每周1、2或3次60分钟治疗）中的一种治疗4周。在为期4周的初级治疗期结束时，最初接受5种剂量组合中的每一种的参与者将被随机分配到不进行额外治疗或每周6次60分钟按摩的次级治疗期。主要结局，颈部相关功能障碍和疼痛，将在随机化后4周、10周和26周通过盲法电话访谈进行评估。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在8、14、18和39周通过邮寄问卷收集的结果数据。比较6组在初级治疗期间的结果将确定最佳周剂量，而比较二级治疗期间的结果将确定10周治疗是否优于4周治疗。本研究的结果将：1)指导按摩治疗方案的发展，用于评估慢性颈部疼痛治疗性按摩的有效性的全面试验；2)作为未来按摩和身体剂量研究的模型；3)帮助解释过去按摩治疗颈部疼痛研究中使用的按摩剂量的充分性。公共卫生相关性：治疗性按摩是颈部疼痛的常用治疗方法，但其有效性尚不清楚。这项研究的目的是找出治疗慢性颈部疼痛的最佳按摩剂量，以便将来的临床试验可以包括一个被认为是最佳的剂量。

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.