NCT00567736已完成3 期
Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Visual analogue scale (0-100 mm) low back pain
研究概览
简要总结
The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.
详细描述
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, 30 to 75 years
- •Willingness of following the study protocol
- •Clinical diagnosis of chronic low back pain
- •Low back pain since at least 3 months
- •Average pain intensity of at least 40 mm on VAS (0-100 mm) in the last 7 days
- •In the last 4 weeks only oral NSAD and muscle relaxation treatment
- •Effective oral contraception in woman
- •Informed consent
排除标准
- •Previous treatment with DISCI comp.
- •Treatment with other than NSAID
- •Routine use of pain drugs for other diseases
- •Protrusio or prolapse of one or more intervertebral discs with neurological symptoms
- •Previous spine surgery
- •(Suspicious) infectious spondylopathy
- •Low back pain because of malignant or infectious disease
- •Other causes of back pain symptoms (e.g. M. Bechterev, M. Reiter)
- •Congenital deformity of spine (without minor lordosis or kyphosis or scoliosis
- •(Suspicious) osteoporosis with compression fracture
- •(Suspicious) spinal stenosis
- •Spondylolysis or spondylolisthesis
- •Physiotherapy in the last four weeks or planed during trial
- •Begin of a new treatment for low back pain
- •Complementary treatment in the last four weeks or planed during trial
- •Patients who are not able to cooperate in a sufficient way
- •Patients with alcohol or substance abuse
- •Participation in another clinical trial
- •Severe chronical or acute disease which does not allow study participation
- •Patients with bleeding disorders or oral anticoagulation treatment
- •Pregnancy and breast feeding
- •Patients with application for pension
- •Patients involved in planning or coordination of the study
- •Hypersensitivity against drug components
研究组 & 干预措施
1
Active Comparator
Disci/Rhus toxicodendron comp.®
干预措施: Disci/Rhus toxicodendron comp.® (Drug)
2
Placebo Comparator
placebo solution
干预措施: placebo solution (Drug)
结局指标
主要结局
Visual analogue scale (0-100 mm) low back pain
时间窗: once after 8 weeks
次要结局
- Back function (back function scale FFbHR)(once at week 8 and 26)
- visual analogue scale (0-100 mm) low back pain(once after week 26)
- days with medication(week 4 to 8)
- quality of life (SF-36)(once at week 8 and 26)
- pain disability scale (PDI)(once at week 8 and 26)
- emotional pain scale (SES)(once at week 8 and 26)
- influence of patient expectancy(once at week 8 and 26)
- influence of physician expectancy(once at week 8 and 26)
- Responder rate 36% VAS pain intensity(once at week 8 and 26)
- numbers of days with absence from work(between week 4 and 8)
- days with physician visits because of low back pain(between week 4 and 8)
研究者
研究点 (1)
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