Wet Cupping (AlHijamah); Double Versus Single Cupping Technique in Chronic Low Back Pain Patients: Randomized Comparative Clinical Trial, Pilot Study Saudi Arabia, 2015
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain Numeric rating scale (NRS) before and after intervention
研究概览
简要总结
Randomized clinical trial to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain.
详细描述
Chronic Low Back Pain is a very common pain disorder in the primary care. As in many chronic pain conditions, patients are usually asking for alternative options, especially local traditional and therapies including wet cupping, to replace the long-term use of painkillers. The majority of the wet cupping trials conducted abroad used different techniques, which is different from our local traditional wet cupping technique. This study can identify the technique that is more efficacious in reducing pain, prolonging the pain relieve period, and decrease patient dependence on painkillers in chronic low back pain.The aim of this study is to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping techniques in chronic low back pain. This a randomized comparative effectiveness pilot clinical trial. After taking written informed consent, patient with chronic low back pain will be randomized into two groups, one group to receive wet cupping therapy with the Traditional double technique, the other group to receive it with the Asian single technique. Numeric Rating Scale, Present Pain Intensity and Oswestry Disability Questionnaire will be used to measure the outcome before and after the intervention, one week after the intervention, then two weeks after. Wilcoxon rank sum test for the continuous dependent data analysis and the analysis of covariance ANCOVA, to compare both groups mean scores will be used. The outcome baseline for each score will be used as the covariate. Chi square or Fisher's exact test will be used to compare categorical data with Minimal Clinical Improvement Difference within and between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •Age equal or more than 18 years up to 60 years
- •Chronic low back pain (at least the duration ≥ 3 months)
- •Not on anti-inflammatory or pain killers for the last 15 days.
排除标准
- •Patients received wet-cupping therapy before in the last three months
- •Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, and cauda equinal syndrome)
- •Patients who are inappropriate to the wet cupping treatment (AIDS, Hepatitis, Tuberculosis, Syphilis. The referring physicians will be advised to exclude those patients)
- •Patients currently receiving any anticoagulant, antiplatelet medications
- •Anemia, thrombocytopenia, Coagulopathy or Hemorrhagic disease like hemophilia
- •Had undergone a surgery, or had bleeding injury, or had blood donation
- •Uncontrolled hypertension, Ischemic heart disease, previous transient ischemic attack or stroke
- •Diabetes, known renal and / or hepatic diseases
- •Patients who are in pregnancy or have plan to conception
- •Previously or currently drug addicts
- •Any other severe disease or disabling medical condition
研究组 & 干预措施
wet cupping : double cupping
wet cupping: (traditional cupping technique): cupping (suction) - Scarification - cupping (suction)
干预措施: wet cupping (Procedure)
wet cupping: single cupping
wet cupping:(Asian cupping): Puncture by needles then cupping (suction):
干预措施: wet cupping (Procedure)
结局指标
主要结局
Pain Numeric rating scale (NRS) before and after intervention
时间窗: 14 DAYS
numeric pain scale to be measured before intervention then two weeks after
次要结局
- pain: McGill, Persistent Pain Intensity (PPI)(14 days)
- functioning (Disability) using the Oswestry Disability Questionnaire (ODQ)(14 days)
- the Safety of the two wet cupping techniques, by collecting safety data after two weeks of the intervention(up to 14 days)
