研究疾病:
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冻结期肩周炎
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研究疾病代码:
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Target disease:
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Freezing period periarthritis of shoulder
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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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1.开展“整肩三步九法”治疗冻结期肩周炎的前瞻性临床研究,对该特色技术的中医基础理论和渊源进行系统梳理,形成该技术的规范化标准操作文本和操作视频,建立培训和技术考核方案;
2.通过临床研究,对该技术的安全性、有效性和卫生经济学进行评价,形成高级别循证医学证据等级和卫生经济学成本-效果比分析报告。
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Objectives of Study:
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1. Carry out a prospective clinical study on the treatment of frozen shoulder periarthritis with ''three steps and nine methods of whole shoulder'', systematically sort out the basic theory and origin of traditional Chinese medicine of this characteristic technique, form a standardized standard operation text and operation video of this technique, and establish Training and technology assessment plan;
2. Through clinical research, evaluate the safety, effectiveness and health economics of the technology, and form a high-level evidence-based medical evidence level and health economics cost-effectiveness ratio analysis report.
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药物成份或治疗方案详述:
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治疗组:整肩三步九法,包括第一步理筋平衡法、第二步整骨平衡法、第三步通络平衡法,手法治疗每周3次,共治疗2周。
对照组:使用温热式中低频治疗仪治疗,每周3次,共治疗2周。
基础治疗:以上两者配合基础治疗可选用爬墙法、画圆运动、手拉牵引康复器训练,每天做3次,每次10-15min。
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Description for medicine or protocol of treatment in detail:
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Treatment group: shoulder three steps and nine methods, including the first step of tendon balance method, the second step of bone balance method, the third step of collateral-dredging balance method, manipulation treatment 3 times a week, a total of 2 weeks.
Control group: the use of warm medium and low frequency treatment instrument treatment, 3 times a week, a total of 2 weeks.
Basic treatment: the combination of the above two basic treatment can choose the wall climbing method, circular exercise, hand-pulled rehabilitation device training, 3 times a day, 10-15min each time.
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纳入标准:
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1.符合肩周炎诊断标准患者,病情分期为冻结期;
2.年龄40~65岁,性别不限;
3.研究前1周内未使用激素或非甾体类消炎药物,未接受过其他相关的治疗;
4.自愿接受手法和物理治疗;
5.已经签署进入知情同意书,并保证完成疗程的患者。
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Inclusion criteria
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1. Patients who meet the diagnostic criteria for shoulder periarthritis, the disease stage is the freezing period;
2. Aged 40 to 65 years;
3. Have not used hormones or non-steroidal anti-inflammatory drugs within 1 week before the study, and have not received other related treatments;
4. Voluntarily receive manual and physical therapy;
5. Patients who have signed the informed consent form and guaranteed to complete the course of treatment.
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排除标准:
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1.哺乳妊娠或正准备妊娠的妇女;
2.过敏体质及对多种药物过敏者;
3.合并肝、肾、造血系统、内分泌系统、心脑血管、神经系统等严重原发性疾病、结核、椎体畸形、恶性肿瘤及精神病患者;怀疑镇静催眠药、阿片类镇痛药及酒精滥用史者;有皮肤性疾病及传染性疾病的患者;
4.病情较重,应该行手术治疗者;
5.其他原因不宜或不能应用本治疗方法的患者;
6.有精神障碍、语言障碍、运动功能障碍、心理疾病的患者。
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Exclusion criteria:
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1. Patients who are breastfeeding pregnant or planning to become pregnant;
2. Allergic constitution and allergic to various drugs;
3. Patients with serious primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardiovascular and cerebrovascular systems, nervous system, tuberculosis, vertebral malformation, malignant tumor and mental illness; suspected history of sedative-hypnotics, opioid analgesics and alcohol abuse; patients with skin diseases and infectious diseases;
4. Those with severe disease who should undergo surgery;
5. Patients who are inappropriate or unable to apply this treatment method for other reasons;
6. Patients with mental disorders, language disorders, motor dysfunction, and mental illnesses.
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研究实施时间:
Study execute time:
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从From
2021-01-01
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2021-08-01
至To
2022-07-31
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