研究疾病:
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急性痛风性关节炎
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研究疾病代码:
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Target disease:
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acute gouty arthritis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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治疗新技术临床试验
New Treatment Measure Clinical Study
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研究目的:
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科学评价颊针治疗急性痛风性关节炎的即时止痛效果、镇痛效应及患者对治疗的评价,为探索一种起效迅速、容易为患者接受、易于推广的新型AGA外治途径提供循证依据,形成颊针治疗急性痛风性关节炎的操作规范。
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Objectives of Study:
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To evaluate the immediate analgesic effect and patients' evaluation of the treatment of cheek acupuncture on patients with acute gouty arthritis.
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药物成份或治疗方案详述:
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以全息理论及大三焦理论为依据,在颊针基础指导下取穴,选双侧三焦穴、双侧头穴,患侧足穴及踝穴,配穴为足穴与踝穴局部加强穴,采用三角针加强法。治疗时患者仰卧,舒适体位,局部常规消毒,对准穴位快速透皮进针,留针30分钟后出针,出针后,用棉球压迫针孔片刻。
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Description for medicine or protocol of treatment in detail:
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Based on the theory of holography and the theory of the Great Sanjiao, the acupoints were chosen under the guidance of the foundation of cheek acupuncture, selecting bilateral Sanjiao acupoints, bilateral head acupoints, foot and ankle acupoints on the affected side, and matching acupuncture points for local strengthening of the foot and ankle acupuncture points, using the triangular needle strengthening method. The treatment was performed with the patient lying on his back in a comfortable position, with routine local disinfection, rapid transdermal needle entry to the acupuncture points, and needle discharge after 30 minutes of needle retention, after which the needle hole was compressed with a cotton ball for a few moments.
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纳入标准:
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?符合AGA西医诊断标准,单侧踝关节或第一跖趾关节发作患者;
?年龄在18~75岁之间,男女不限;
?患者疾病处于AGA发作48小时内;
?本次AGA发作首次就诊且未接受针对性外治法治疗或者自行服用药物包括秋水仙碱、抗炎止痛药物、激素、中药等;
?愿意服从医生的治疗方案并配合随访。
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Inclusion criteria
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① Meet the diagnostic criteria for acute gouty arthritis and with attacks in the unilateral ankle or first metatarsophalangeal joint;
② 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.
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排除标准:
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?妊娠或哺乳期妇女;
?不符合AGA诊断标准者;
?正在参加其它类似干预治疗者;
?合并严重肝肾功能不全、心脑血管疾病、肿瘤、血液系统疾病、糖尿病、高血压病等;
?精神病患者,不能理解研究性质、范围或不能遵守医嘱者;
?对中药或者西药任何一种成份过敏;
?有活动性消化道溃疡/出血,或者既往曾复发溃疡/出血的患者;
?服用阿司匹林或其他非甾体类抗炎药后诱发哮喘、荨麻疹或过敏反应的患者;
?充血性心衰(纽约心脏病学会[NYHA]心功能分级 II-IV)。
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Exclusion criteria:
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① Pregnant or breast-feeding
② Patients with malignant tumors, severe dysfunction of the heart, liver, and kidneys, diabetes mellitus and hypertension
③ 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
④ Allergic to the components of the drug in this study
⑤ Patients with active peptic ulcers/bleeding, or previous recurrent ulcers/bleeding.
⑥ History of asthma, urticaria or allergic reactions induced by taking aspirin or other non-steroidal anti-inflammatory drugs
⑦ Congestive heart failure (New York Heart Association [NYHA] cardiac function class II-IV)
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研究实施时间:
Study execute time:
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从From
2021-07-01
至To
2023-07-31
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征募观察对象时间:
Recruiting time:
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从From
2022-01-01
至To
2023-07-31
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