The Effectiveness of the Physiotherapy Techniques Group GDS and Individual GDS for the Treatment of Nonspecific Low Back Pain in Primary Care. A Cluster, Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 461
- 试验地点
- 2
- 主要终点
- Low back pain, referred pain and disability
研究概览
简要总结
A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will be the participating physiotherapy departments in primary care who treat patients with low back pain. In each physiotherapy department there will be 3 groups: education group, Group GDS and Individual GDS. Patients will be followed for 12 months. Variables will be: demographic,intensity of pain, disability, quality of life, patient satisfaction, medication intake for current episode, non-pharmacologic treatment for current episode, co-morbidity, diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with nonspecific low back pain by the primary care physician
- •more than or equal to 18 and less than or equal to 65 years of age
排除标准
- •not signing the informed consent form
- •pregnancy
- •diagnosis of inflammatory rheumatologic disease, cancer, or fibromyalgia
- •signs for suspicion of fibromyalgia
- •having red flags for systemic disease
- •presenting criteria for urgent referral to surgery
- •presenting criteria for non-urgent referral to surgery
- •inability to read, understand, or follow verbal orders (dementia,blindness, doesn´t know how to read)
- •bedridden
- •having received physiotherapy in last 12 months
结局指标
主要结局
Low back pain, referred pain and disability
时间窗: Baseline, 2, 6 and 12 months
次要结局
- Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments(Baseline, 2, 6 and 12 months)
研究者
Francisco M. Kovacs
Director of Scientific Department, Kovacs Foundation
Kovacs Foundation