Wet Cupping Therapy in Ankylosing Spondylitis: a Multicenter Quasi- Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- BASDAI
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 every 28 days , 3 times (Day 0, 28, 56) to the intervention group whereas the control group will not receive any intervention. The BASFI, BASDAI, CRP, FFD, VAS and Modified Schober (MSI) tests 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
- •Age between 18-65 years
- •Confirmed diagnosis of ankylosing spondylitis (AS) according to the modified New York criteria or the ASAS classification criteria for axial spondyloarthritis
- •Active disease at enrolment, confirmed by a PM&R specialist
- •Written informed consent and compliance with the study protocol
排除标准
- •Having received WCT within the previous 3 months
- •Contraindications to WCT (hemoglobin <9.5 g/dL, known bleeding or coagulation disorders, anticoagulant use or antiplatelet therapy other than aspirin <100 mg, INR >1.5, etc.)
- •Pregnancy or breastfeeding
- •Severe uncontrolled comorbidities (e.g., advanced cardiovascular disease, uncontrolled diabetes, active malignancy, severe psychiatric illness)
- •Any change in AS medication during the study period
- •Failure to complete either baseline or follow-up visits
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
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 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