研究疾病:
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腱病
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研究疾病代码:
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Target disease:
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Tendinopathy
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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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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针对腱病保守治疗及腱病修复术后康复治疗,开展随机对照临床试验研究,建立规范化的中西医联合治疗方案,证实其在腱病治疗全过程中的重要作用,形成规范化的中西医联合治疗方案。并向基层及社区医院推广应用,提供更为便捷、优质的治疗方法。为中西医整体治疗在运动损伤及其术后康复治疗中的重要作用提供理论依据,从而进一步提升中医药在运动损伤术后治疗水平和服务能力。
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Objectives of Study:
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For the conservative treatment of tendinopathy and the rehabilitation treatment after tendinopathy repair surgery, randomized controlled clinical trial studies are conducted to establish standardized Chinese and Western medicine combined treatment protocols, confirming their important role in the whole process of tendinopathy treatment and forming standardized Chinese and Western medicine combined treatment protocols. We will also promote its application to grassroots and community hospitals to provide more convenient and high-quality treatment methods. To provide theoretical basis for the important role of Chinese and Western medicine holistic treatment in sports injuries and their postoperative rehabilitation, so as to further enhance the level and service ability of Chinese medicine in postoperative treatment of sports injuries.
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药物成份或治疗方案详述:
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对所有符合纳入标准的患者行放散式冲击波治疗1疗程(3-5次,每次间隔1周)。试验组患者在上述冲击波治疗基础上,增加中药足浴6周,方用筋骨通络方,具体组成为:伸筋草12、透骨草12g、川椒6g、威灵仙10g、鸡血藤15g、海桐皮12g、川芎10g,为控制因药物煎煮等方面产生的差异选取配方颗粒,并使用2L水稀释,足浴水温控制在38℃-40℃,时长20分钟,每日1次。
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Description for medicine or protocol of treatment in detail:
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All patients who met the inclusion criteria were treated with discharging shockwave therapy for 1 course of treatment (3-5 times, each time with an interval of 1 week). On the basis of the above shockwave treatment, the patients in the test group were given a Chinese herbal footbath for 6 weeks, using the Jingu Tongluo Fang, which consisted of 12g of Elongated Tendon Grass, 12g of Turbinaria Bone Grass, 6g of Chuanjiao Pepper, 10g of Wellingtonia Sinensis, 15g of Chickweed Vine, 12g of HaiTongPi, 10g of Chuanxiong Ligustici, and the formula granules were selected to control the difference due to decoction of the medicines, etc., and the formula granules were diluted using 2L of water. The water temperature of the footbath was controlled at 38℃-40℃, and the duration was 20 minutes, once a day.
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纳入标准:
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(1)符合诊断标准;(2)18周岁≤年龄≤65周岁;(3)言语流利,神志清晰,可准确评价及描述自身不适症状;(4)签署知情同意书。
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Inclusion criteria
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(1) meet the diagnostic criteria; (2) 18 years old ≤ age ≤ 65 years old; (3) speak fluently, have clear mental clarity, and can accurately evaluate and describe their own discomfort; (4) sign the informed consent form.
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排除标准:
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1)患侧肢体存在跟骨骨折;(2)跟腱断裂;(3)扁平足、高弓足、踝关节内外翻畸形等;(4)瘢痕体质、过敏体质或存在既往外用中药过敏史;(5)既往肿瘤病史或关节特异及非特异性滑膜炎症患者;(6)BMI体重指数超过正常范围20%;(7)存在体外冲击波疗法禁忌证 (装有心脏起博器、出血性疾病、肿瘤、血栓形成、妊娠、治疗部位感染及皮肢破溃等)
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Exclusion criteria:
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(1) Achilles fracture of the affected limb; (2) Achilles tendon rupture; (3) flat foot, high arched foot, ankle inversion deformity, etc.; (4) keloid, allergy, or history of allergic reactions to previous topical herbs; (5) history of tumors or joint-specific and nonspecific synovitis; (6) BMI exceeding 20% of the normal range; (7) contraindications to extracorporeal shockwave therapy (cardiac pacemakers, bleeding disorders, tumors, thrombosis, pregnancy, infections of the treatment site, and ulceration of the skin limb, etc.).
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研究实施时间:
Study execute time:
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从From
2023-12-01
至To
2025-12-31
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征募观察对象时间:
Recruiting time:
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从From
2024-04-23
至To
2025-02-01
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