Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Median time in days to recovery of pain.
研究概览
简要总结
Acute low back pain is a common disorder in general practice. Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition.
The aim of this study is to evaluate whether a single treatment-session with acupuncture can reduce time to recovery when applied in addition to standard LBP-treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out.
The investigators hypotheses are:
- Acupuncture treatment contributes to faster pain-recovery in acute LBP compared to standard treatment in general practice provided in accordance with the Norwegian national guidelines.
- Acupuncture treatment for acute LBP improves function, and reduces drug use and sick leave, compared to the standard treatment in general practice provided in accordance with national guidelines.
- Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.
The investigators intend to include a total of 270 patients, 135 in the intervention group and 135 in the control group.
The investigators planned to do an interim analysis when reaching inclusion of 150 patients. However, this might lead to reduced overall significance level, and as a result of slow inclusion rate (by December 2015), the investigators plan to extend the inclusion time with one year and then complete the study in March 2017.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
排除标准
- •Nerve root affection and/or radiating pain below the knee.
- •Low back pain with suspected "red flags", i.e. infections, tumors and metastatic disease, rheumatic disease, fractures and significant deformities of the spine.
- •Low back pain which starts in pregnancy.
- •Physician reported sick leave of 14 days or more during the last month before the back pain, for any reason.
结局指标
主要结局
Median time in days to recovery of pain.
时间窗: 1 year
The median time in days to recovery of pain is measured at the first day the patient scores 0 or 1 point on the Numerical Rating Scale (NRS).
次要结局
- Back specific functional status(1 year)
- Visits at the GP(1 year)
- Use of medication(1 year)
- Side effects of treatment(1 year)
- Reduction in pain(1 year)
- Global measure of improvement(1 year)
- Sick leaves(1 year)
研究者
Arne Fetveit
Associate Professor
University of Oslo