Effect of Massage on Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 2
- 主要终点
- Dysfunction at 10 weeks
研究概览
简要总结
This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.
详细描述
Americans are increasingly seeking care from massage therapists for relief of chronic back pain. However, while initial studies suggest that massage is beneficial for back pain, we have no information about which of the many types of massage is most helpful. We will be conducting a study that compares two distinct therapeutic massage protocols with each other and with usual care for treating chronic back pain. This study is designed to determine which of these massage protocols will be most effective in reducing pain and increasing functionality in people with low back pain. 399 Group Health members with non-specific low back pain lasting at least 3 months will be randomized to one of the two massage groups or to a control group that receives no treatment beyond their usual care. Massage therapists will provide each participant with 10 treatments over 10 weeks. The primary outcomes, function and bothersomeness of low back pain, will be assessed before treatment begins and 10, 26 and 52 weeks after randomization by interviewers who do not know which treatment the participant received. The results of this study will clarify the value of two different types of massage for treating one of the most common, challenging, and expensive health problems plaguing developed countries. The findings will help physicians make informed and confident referrals, consumers and insurers make safe and cost-effective choices, and massage schools make responsible curriculum decisions.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 through 64 years of age
- •members of Group Health Cooperative health plan
- •low back pain lasting at least 3 months
排除标准
- •non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture)
- •inappropriate candidate for massage (active open skin lesions, conditions exacerbated by increased circulation, recent strokes or heart attacks, compromised immune system, systemic edema, hypersensitivity to touch or loss of sensation, recent surgery, active contagious infection)
- •characteristics complicating the interpretation of findings (e.g., involved with litigation or compensation claim, severe or progressive neurological deficit, back surgery within last 3 years, receiving other back treatment)
- •unable to speak or read English
- •had massage for any reason in prior 12 months
研究组 & 干预措施
2
structural massage
干预措施: massage (Procedure)
1
relaxation massage
干预措施: massage (Procedure)
结局指标
主要结局
Dysfunction at 10 weeks
时间窗: 10 weeks
Symptom bothersomeness at 10 weeks
时间窗: 10 weeks
次要结局
- Dysfunction at 26 and 52 weeks(26 and 52 weeks)
- Anxiety at 10, 26 and 52 weeks(10 16 and 52 weeks)
- Symptom bothersomeness at 26 and 52 weeks(26 adn 52 weeks)
- General health status (SF-36) at 10, 26 and 52 weeks(10, 26 and 52 weeks)
- Disability days at 10, 26 and 52 weeks(10 26 52 weeks)
- Depression at 10, 26 and 52 weeks(10 26 and 52 weeks)
- Perceived stress at 10, 26 and 52 weeks(10 26 and 52 weeks)
- Fear avoidance at 10, 26 and 52 weeks(10 26 and 52 weeks)
- Satisfaction with back care at 10 and 26 weeks(10 and 26 weeks)
- Perceptions of massage treatments at 10, 26 and 52 weeks(10 26 52 weeks)
- Use and cost of health care services for back pain at 10, 26 and 52 weeks(10 26 52 weeks)
- Medication use at 10, 26 and 52 weeks(10 26 52 weeks)
- Adverse experiences at 10 weeks(10 weeks)