Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Visual Analogue Scoring (VAS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the immediate analgesic effect and patients' evaluation of the treatment of cheek acupuncture in patients with acute gouty arthritis. The main question it aims to answer are: Does cheek acupuncture has immediate pain relief effects on patients with acute gouty arthritis. Participants will received cheek acupuncture for 30 mins.
If there is a comparison group: Researchers will compare etoricoxib group to see if cheek acupuncture is superior to etoricoxib for improvement of acute pain in subjects with acute gouty arthritis.
详细描述
The symptoms of acute gouty arthritis (AGA) are extremely painful, but most patients do not begin to experience pain relief until after they have been seen by a doctor and have taken their medication, leaving a time lag between the time they are seen and the time the treatment is effective. In clinical practice, researchers have found that the use of cheek acupuncture at the first visit to the patient often provides some immediate pain relief, but there is no evidence-based evidence for this.
This project was designed as a prospective, randomized, controlled clinical trial, in which patients with AGA who were seen for the first time were studied, and the treatment group was given cheek acupuncture and the control group was given oral etoricoxib tablets. VAS will be recorded before treatment, 0 min, 30 min, 1 h and 2 h after the start of treatment to depict the immediate analgesic efficacy curve and compare the immediate analgesic effect of the two groups at different time points. If the project is successfully completed, it will explore a treatment method for acute gouty arthritis that is fast-acting, painless and effective, eliminating the time lag between consultation and efficacy for the benefit of gout patients.
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 (Outcomes Assessor)
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
- •Meet the diagnostic criteria for acute gouty arthritis and with attacks in the unilateral ankle or first metatarsophalangeal joint;
- •Age ≥18 years old and ≤75 years old, regardless of gender; ③ The gouty arthritis attack is within 48h; ④ Without therapy with targeted topical treatment or self-administered medications including colchicine, anti-inflammatory pain medications, hormones, herbs, etc.
- •Agreement to comply with the clinician's treatment plan.
排除标准
- •Pregnant or breast-feeding
- •Patients with malignant tumors, severe dysfunction of the heart, liver, and kidneys, diabetes mellitus and hypertension
- •Mental disorders that render the patient unable to understand the nature of the study, its scope, and possible outcomes or unable to follow the doctor's advice
- •Allergic to the components of the drug in this study
- •Patients with active peptic ulcers/bleeding, or previous recurrent ulcers/bleeding.
- •History of asthma, urticaria or allergic reactions induced by taking aspirin or other non-steroidal anti-inflammatory drugs
- •Congestive heart failure (New York Heart Association [NYHA] cardiac function class II-IV)
研究组 & 干预措施
acupuncture group
subjects will received cheek acupuncture for one time
干预措施: cheek acupuncture (Other)
etoricoxib
subjects will received etoricoxib 120mg for one time
干预措施: Etoricoxib (Drug)
结局指标
主要结局
Visual Analogue Scoring (VAS)
时间窗: baseline, 0 minute, 30 minutes, 1 hour and 2 hours after the start of treatment
a 10 cm long horizontal or vertical line that divides the pain level into 10 levels (i.e., 1 level for every 1 cm), with the leftmost (or upper) end representing "no pain" and the rightmost (or lower) end representing "severe pain The leftmost (or upper) end represents "no pain" and the rightmost (or lower) end represents "severe pain", and the patient is asked to mark the pain level he/she feels with an "I" on this line.
次要结局
- Patient feedback score(2 hours after the start of treatment)
- Immediate pain relief(2 hours after the start of treatment)
研究者
Yuping Lin
Clinical Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine