Wet Cupping Therapy in Ankylosing Spondylitis: a Multicenter Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics
详细描述
In addition to the medical treatment, WCT will be applied once a month, 3 times (Day 0, 30, 60) to the intervention group whereas the control group will not receive any intervention. The BASFI, BASDAI, VAS and Schober test will be applied to both groups at 0 and 3 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of ankylosing spondylitis 18-65 years of age Consent to participate
排除标准
- •Any ongoing medical treatment other than NSAIDs Pregnancy At least one contraindication to WCT that was detected in subject's history or in the routine blood examinations prior to enrollment (Hgb <9.5; INR> 1.2; history of hemophobia, bleeding disorder, malignant disorder).
研究组 & 干预措施
Wet cupping arm
This arm is the interventiom group and will receive three consecutive sessions of wet cupping therapy once a month.
干预措施: wet cupping therapy (Procedure)
Control arm
This arm is the control group and will not receive any intervention other than the routine medications
结局指标
主要结局
VAS
时间窗: At 0 and 3 months
Change in the scores of Visual Analogue Scale
BASFI
时间窗: At 0 and 3 months
Change in the scores of The Bath Ankylosing Spondylitis Functional Index
BASDAI
时间窗: At 0 and 3 months
Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index
BASDAI
时间窗: At 0 and 9th weeks
Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index
次要结局
- Schober(At 0 and 3 months)
- Schober(At 0 and 9th weeks)
- BASFI(At 0 and 9th weeks)
- VAS(At 0 and 9th weeks)
- C Reactive Protein (CRP)(At 0 and 9th weeks)
- fingertip-to-floor distance (FFD),(0 th and 9 th weeks)
研究者
SULEYMAN ERSOY
Head of the complementary medicine department
Karabuk University