Randomised Controlled Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.
详细描述
see above
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75
- •permanent neck pain for at least three months in a row
- •a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)
- •having been in treatment to an orthopaedic or to a neurologist
排除标准
- •neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.
- •invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.
- •serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.
- •non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
结局指标
主要结局
Pain intensity
时间窗: at T2 (Day 25)
100mm Visual Analogue Scale
次要结局
- pain related to movement(at T2 (Day 25))
- pain diary(from T0 (Day 0) to T2 (Day25))
- Neck disability index(at T2 (Day 25))
- Quality of Life SF-36(at T2 (Day 25))
- mechanical detection threshold MDT(at T2 (Day 25))
- vibration detection threshold VDT(at T2 (Day 25))
- pressure pain threshold PPT(at T2 (Day 25))
- Side effects(from T1 (Day 7) to T2 (Day 25))
- Medication diary(From T0 (Day 0) to T2 (Day 25))