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临床试验/NCT01122836
NCT01122836已完成不适用

Dosing Study of Massage for Neck Pain

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2010年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
2
主要终点
Improvement in neck related dysfunction

研究概览

简要总结

This study is designed to determine the most effective dose of massage for persons with chronic neck pain. This information is necessary before more definitive studies can be conducted.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms consistent with non-specific, uncomplicated neck pain of at least moderate level of pain
  • Lives or works within Greater Seattle WA geographic area

排除标准

  • Cervical Radiculopathy
  • History of cancer (other than nonmelanoma skin cancer)
  • Severe disk problems
  • Unstable medical conditions
  • Previous neck surgery
  • Physically unable to get on and off of a massage table
  • Has had massage within the last year
  • Currently in litigation for neck pain
  • Seeking other treatment for neck pain
  • Potential contraindications for massage
  • Unable to give informed consent

研究组 & 干预措施

Massage - Dose 3

Experimental

This arm receives 2 weekly 30-minute massage for 4 weeks.

干预措施: Massage (Other)

Massage - Dose 4

Experimental

This arm receives 2 weekly 60-minute massages for 4 weeks.

干预措施: Massage (Other)

Massage - Dose 5

Experimental

This arm receives 3 weekly 30-minute massages for 4 weeks.

干预措施: Massage (Other)

Massage - Dose 6

Experimental

This arm receives 3 weekly 60-minute massages for 4 weeks.

干预措施: Massage (Other)

Massage Dose 1

Experimental

This arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment.

干预措施: Massage (Other)

Massage - Dose 2

Experimental

This arm receives weekly 60-minute massage for 4 weeks.

干预措施: Massage (Other)

结局指标

主要结局

Improvement in neck related dysfunction

时间窗: 4 weeks

Evidence of clinically important improvement according to the Neck Pain Disability Index

Improvement in pain levels

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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