Dosing Study of Massage for Neck Pain

颈部疼痛按摩的剂量研究

• 批准号: 7835852
• 负责人: KAREN J SHERMAN
• 金额: $ 71.04万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7835852
• 关键词: Address; Adult; American; Area; Back Pain; Blinded; Chronic; Chronic neck pain; Clinical Trials; Control Groups; Country; Data; Development; Dose; Effectiveness; Foundations; Frequencies; Functional disorder; Future; Individual; Interview; Interviewer; Knowledge; Length; Longitudinal Studies; Mails; Massage; Mechanics; Medical; Modeling; Neck; Neck Disorder; Neck Pain; Outcome; Pain; Participant; Persons; Questionnaires; Randomized; Research; Telephone; Therapeutic; Treatment Failure; Treatment Protocols; Waiting Lists; alternative treatment; arm; design; effective therapy; primary outcome; public health relevance; systematic review; therapeutic effectiveness; treatment duration; treatment effect

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.

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。许多美国人发现传统的医疗方法对这个常见且昂贵的问题无效，并且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，这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了低“剂量”的按摩，按摩治疗师认为这是不够的。不幸的是，每次按摩的分钟数、每周的按摩次数或按摩达到有益或最佳效果所需的治疗周数尚不清楚。本研究旨在通过确定慢性颈部疼痛患者的这些知识差距来弥补我们的知识空白：1）每周治疗次数和个体治疗疗程长度的最佳组合，以及 2）最佳治疗周数。在该项目中，228 名患有慢性非特异性颈部疼痛的患者将被随机分入等候名单对照组，或接受 5 种不同剂量组合之一的 4 周治疗（每周 2 或 3 次 30 分钟治疗，或 1、2 或每周 3 次每次 60 分钟的治疗）。在这 4 周的主要治疗期结束时，最初接受 5 种剂量组合的参与者将被随机分配到没有额外治疗或每周 6 次 60 分钟按摩的次要治疗期。主要结果，即颈部相关功能障碍和疼痛，将由盲法电话访谈员在随机分组后 4、10 和 26 周进行评估。为了更好地描述治疗效果持续性的轨迹，这些访谈数据将辅以在第 8、14、18 和 39 周通过邮寄问卷收集的结果数据。比较 6 组在主要治疗期间的结果将确定最佳每周剂量，而比较次要治疗期间的结果将确定 10 周的治疗是否优于 4 周。这项研究的结果将：1）指导按摩治疗方案的开发，用于评估治疗性按摩对慢性颈部疼痛的有效性的全面试验，2）作为未来按摩和治疗的剂量研究的模型。身体工作，3) 帮助解释过去颈部疼痛按摩研究中使用的按摩剂量是否充足。公共健康相关性：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最佳的剂量。