Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in pain, using visual analogue scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy.
60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. They are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. Additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The clinical outcome will be primarily measured by pain intensity using a visual analogue scale. Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale, Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the difference in change of scores between groups using one-way t-test.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low back pain for less than 3 months
排除标准
- •Patients with relevant leg pain
- •Patients with spine operations in the past
- •neurologic symptoms
- •scoliosis with Cobb angle > 10°
- •Patients experienced in shock wave therapy
- •Patientes with ongoing therapy with blood diluting drugs such as phenprocumon
- •Patients with osteoporosis
- •Patients with back pain after trauma
- •Patients with infective diseases or tumor diseases
- •Patients with relevant psychological diseases
结局指标
主要结局
Change in pain, using visual analogue scale (VAS)
时间窗: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Change in pain, using visual analogue scale (VAS 1-10)
次要结局
- Change in other clinical questionnaires (Beck's depression scale)(day 0; 7; 14; 21, after 6 and 8 weeks.)
- Change in other clinical questionnaires (Oswestry disability Index)(day 0; 7; 14; 21, after 6 and 8 weeks.)
- Change in other clinical questionnaires (EQ-5D)(day 0; 7; 14; 21, after 6 and 8 weeks.)
- Change in other clinical questionnaires (Roland-Morris-Score)(day 0; 7; 14; 21, after 6 and 8 weeks.)
研究者
Niklas Deventer
Dr. med. Niklas Deventer
University Hospital Muenster