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，常规医疗治疗对这个常见和昂贵的问题无效，并且越来越多地尝试互补和替代治疗，包括治疗性按摩。尽管按摩的普及越来越普及，但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差。先前研究的主要缺乏是他们使用按摩治疗师认为不足的低“剂量”按摩。不幸的是，尚不清楚每个按摩疗程，每周一次或按摩所需的几周治疗的数分时间。这项研究旨在通过确定慢性颈部疼痛的人来解决我们的知识中的这些差距：1）每周治疗数量和个体治疗时间长度的最佳组合，以及2）最佳治疗数量。在这个项目中，有228名患有慢性非特异性颈部疼痛的人将被随机分为等待名单对照组，或者使用5种不同的剂量组合之一（每周2或3 30分钟治疗）之一（每周1、2或3 60分钟治疗）。在这个为期4周的初级治疗期结束时，最初接受5个剂量组合中每一种的参与者将被随机分为无额外治疗或6个每周60分钟按摩的次要治疗期。盲目的电话访调员4、10和26周，与颈部相关的功能障碍和疼痛的主要结果将评估。为了更好地描述治疗效果持续性的轨迹，这些访谈数据将补充邮寄问卷收集的结果数据，分别为8、14、18和39周。在初级治疗期间，6组的结局比较将确定最佳的每周剂量，而在继发治疗期间的结局比较将确定10周的治疗方法是否优于4周。这项研究的结果将：1）指导按摩治疗方案的开发，该方案将用于评估治疗性按摩在慢性颈部疼痛方面的有效性，2）作为对按摩和身体工作的未来剂量研究的模型，3）有助于解释过去对颈部疼痛的按摩剂量的剂量的适当性。公共卫生相关性：治疗性按摩是一种常用的颈部疼痛治疗方法，但其有效性尚不清楚。这项研究旨在找出慢性颈部疼痛的最佳按摩剂量是什么，以便将来的临床试验包括被认为是最佳的剂量。