Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA, USA.
BMC Complement Altern Med. 2012 Sep 18;12:158. doi: 10.1186/1472-6882-12-158.
Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, 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.
METHODS/DESIGN: In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants 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-min treatments per week or 1, 2, or 3 60-min 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-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 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.
A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued.
This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836
尽管按摩越来越受欢迎，但它治疗颈部疼痛的效果仍不清楚，主要是因为研究质量较差。以前的研究主要缺陷在于按摩师认为剂量不足，使用了低剂量的按摩。不幸的是，对于按摩产生有益或最佳效果所需的每次按摩的分钟数、每周的按摩次数或治疗周数，我们并不清楚。本研究旨在通过确定慢性颈痛患者的以下问题来解决我们知识中的这些空白：1）每周治疗次数和每次治疗时间的最佳组合，以及 2）最佳治疗周数。
方法/设计：本研究将从西雅图地区一个大型医疗保健系统的初级保健诊所招募 228 名慢性非特异性颈痛患者。参与者将被随机分配到等待名单对照组或接受 4 周的治疗，治疗方案为每周接受 2 或 3 次 30 分钟的治疗，或每周接受 1、2 或 3 次 60 分钟的治疗。在这 4 周的主要治疗期结束时，最初接受这 5 种剂量组合的参与者将被随机分配到次要治疗期，要么不接受额外治疗，要么接受每周 6 次 60 分钟的按摩。通过盲法电话访谈者在随机分组后 5、12 和 26 周评估颈部相关功能障碍和疼痛等主要结局。为了更好地描述治疗效果的轨迹，这些访谈数据将通过互联网问卷在第 10、16、20 和 39 周收集的结果数据进行补充。在主要治疗期间，对 6 组的结果进行比较将确定最佳每周剂量，而在次要治疗期间，对结果进行比较将确定 10 周的治疗是否优于 4 周。
本试验纳入了广泛的剂量方案。如果任何一种剂量的依从性都很差，将停止使用该剂量。
本试验在 ClinicalTrials.gov 注册，注册号为 NCT01122836。
