感谢（1）国家自然科学基金（81973877）、（2）《上海市进一步加快中医药传承创新发展三年行动计划》（ZY （2021-2023）-0201-01）、（3）浦东新区卫生系统浦东名医师培训计划（PWRzm2020-15）和（4）中医康复服务提升项目（医疗032）的财政支持。

本研究方案已获得上海中医药大学附属龙华医院人体研究伦理委员会批准（批准文号：2023-LHXS-030）。在试验之前，研究中的每位患者都提供了书面知情同意书。选取2022年12月至2023年5月上海中医药大学附属龙华医院康复科I-II.期腰周炎患者76例，符合纳入标准，随机分为对照组和治疗组，每组38例。操作者必须熟悉肩关节的解剖结构和具体的手术方法。
1. 招募患者
<ol><li>使用以下纳入标准将患者纳入本研究：符合肩周炎的诊断标准;I期或II期肩周炎;不分性别，40-65岁;VAS 评分≤ 7;同时没有其他治疗。</li>
	<li>使用以下排除标准不包括本研究的患者：凝血功能障碍患者;血糖控制不稳定的糖尿病患者;孕妇和哺乳期妇女;治疗部位受损或严重感染的患者;对麻醉过敏的患者。</li>
</ol>2. 对照组的练习制度
<ol><li>对照组患者进行如下所述的功能锻炼疗程19.<ol><li>手攀岩：让患者面向墙壁站立，双脚张开，举起双手沿墙向上攀爬。要求患者将手放在最大公差的最高刻度上，并为每位患者记录下来。</li>
		<li>辅助手：在站立姿势下，要求患者将患上肢保持在向后伸展的状态，并用健康的上肢拉动患上肢的手腕，向另一侧进行内旋，然后保持向上拉的状态，直到患者的最大耐受性。</li>
		<li>摆锤摆动：在站立和弯腰姿势下，要求患者支撑每个患者的健康手臂并下降到患侧，进行来回、左右以及圆圈运动。当症状改善时，增加运动范围，并通过握住1-2公斤的物体（如水瓶、哑铃）画圈，以增加伸展运动的强度。</li>
	</ol></li>
	<li>功能锻炼过程：确保对照组患者每天进行功能锻炼，包括爬墙、辅助手和摆动，每天 30 次，持续 4 周。 注意： 功能锻炼必须在公差范围内进行;否则，可能会导致肩部软组织拉伤并导致病情恶化。</li>
	<li>在功能锻炼过程中，遵循从轻到重，从小到大，循序渐进，持续不断的原则。要求患者避免长期肩部工作、提重物或剧烈活动，尽管患者可以在治疗期间进行所有日常活动。</li>
</ol>3. 治疗组的运动方案
<ol><li>对治疗组的患者进行小针刀治疗和功能锻炼。</li>
	<li>术前准备<ol><li>材料准备（图1）：一次性医用塑料杯、医用镊子、吸水棉球、敷料块、40 mm x 40 mm一次性无菌小针刀、记号笔、II型皮肤消毒剂、2%盐酸利多卡因、无菌注射用水、10mL一次性无菌注射器、一次性无菌注射针、橡胶手术手套、不干胶敷料。</li>
		<li>患者信息检查：检查每个患者的基本信息（姓名、年龄、受影响的肩部）。说明小针刀疗法的工艺和优点。确保患者在手术过程中完全理解和放松。</li>
		<li>患者准备：以坐姿完全暴露受影响的肩膀。</li>
		<li>体位（图2）：标记患肩的明显压痛点，如喙突点（肱二头肌短头的附着点）、大结节的小结节（肩胛下肌的附着点）、结节间沟（肱二头肌长头的附着点）、肩峰下滑囊（冈上肌的附着点）、 肱骨大结节（圆小肌附着点）后方 2 厘米20。</li>
		<li>消毒：在II型皮肤消毒剂中准备棉球。常规对皮肤进行 3 次消毒，从标记点周围 15 厘米开始逐渐减小直径。</li>
	</ol></li>
	<li>操作程序（图2）<ol><li>将 5 mL 2% 利多卡因和 5 mL 无菌水加载到 10 mL 注射器中，以制备 10 mL 1% 利多卡因工作溶液。</li>
		<li>将22G针头换成25G针头（使用较细的针头缓解疼痛）。左手戴上无菌手套，右手握住注射器。</li>
		<li>将针头插入标记处，并确保抽吸时没有血液回流。在每个标记点垂直注射 1-2 mL 1% 利多卡因工作溶液。</li>
		<li>小针刀插入（图2）：右手戴上无菌手套握住小针刀。将小针刀垂直垂直插入利多卡因注射部位，深度约为1-3厘米。确保小针刀的刀刃与肌肉纤维平行，以免损伤重要的血管和神经。</li>
		<li>执行纵向切口的3步操作，剥离和释放粘附物7,15。患者会感到局部酸痛和疼痛，操作者会在刀下感到阻力。</li>
		<li>当操作者感觉到刀下有松动感时，拔出针头。</li>
	</ol></li>
	<li>术后护理（图2）<ol><li>用干燥的无菌棉球按压注射部位1分钟。用无菌自粘敷料覆盖操作区域。</li>
		<li>协助患者穿好衣服。 注意： 将医疗废物放入医疗废物垃圾桶中。</li>
		<li>请患者在离开手术室前静坐约15分钟，以免术后不适。建议患者保持自粘敷料干燥，直到 48 小时后取出，以避免出血和感染。</li>
	</ol></li>
	<li>小针刀治疗疗程 21：对治疗组患者进行小针刀治疗，每周一次，共 4 次。对治疗组的患者进行与对照组相同的功能锻炼。</li>
</ol>4. 干预后结果评估
<ol><li>评价指标 22,23,24<ol><li>使用视觉模拟评分 （VAS）、常数和默雷评分 （CMS） 以及超声下 CHL 的厚度来评估结果。 注意：基线测量是在治疗前和治疗后一周进行的。</li>
	</ol></li>
	<li>评估工具<ol><li>使用GJJDC01高精度关节运动电子测量仪器进行肩关节运动测量和便携式彩色超声系统（图3）。</li>
	</ol></li>
	<li>评估工具操作方法（图3）<ol><li>测量肩关节活动度。<ol><li>按 ON 打开电源。要求受试者将肩膀抬高到尽可能大的角度。旋转测量尺，得到测量值。</li>
			<li>将测量仪器刻度设置回 0 并重复测量 2 次。按住 OFF 可关闭电源。</li>
		</ol></li>
		<li>使用超声波测量 CHL 的厚度。<ol><li>按 电源 按钮打开超声波机。按 “患者 ”按钮，单击 “新建患者”，然后输入受试者的姓名。</li>
			<li>要求患者以坐姿完全暴露患肩。被动移动患者的肩关节以定位 CHL。 将超声探头与 CHL 对齐。</li>
			<li>按 冻结 按钮保存超声图像。按卡 尺 按钮测试 CHL 厚度。记录测量结果并将其关闭。</li>
		</ol></li>
	</ol></li>
</ol>5. 统计分析
<ol><li>将连续变量表示为平均值±标准差 （SD）。使用独立样本 t 检验来比较两组之间的差异。所有统计检验均为双侧检验， P<0.05 被认为具有统计学意义。所有分析均使用统计软件进行。</li>
</ol>

小针刀治疗肩周炎的疗效

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F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Effect+of+small+needle+knife+and+local+closure+on+pain+mediators+and+inflammatory+factors+in+patients+with+frozen+shoulder.">Effect of small needle knife and local closure on pain mediators and inflammatory factors in patients with frozen shoulder.</a> Clin Res Chinese Med. 10 (8), 82-84 (2018).</li><li>Bunker, T. D., Reilly, J., Baird, K. S., Hamblen, D. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Expression+of+growth+factors,+cytokines+and+matrix+metalloproteinases+in+frozen+shoulder.">Expression of growth factors, cytokines and matrix metalloproteinases in frozen shoulder.</a> J Bone Joint Surg Br. 82 (5), 768-773 (2000).</li><li>Millar, N. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Frozen+shoulder.">Frozen shoulder.</a> Nat Rev Dis Primers. 8 (1), 59 (2022).</li><li>Li, H. Y., Chen, S. Y., Zhai, W. T., Chen, J. W. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Expression+of+TGF-&#946;+and+MMPs+in+capsula+tissue+of+frozen+shoulder+patients.">Expression of TGF-&#946; and MMPs in capsula tissue of frozen shoulder patients.</a> J Shanghai Jiaotong Uni. 29 (11), 1363-1366 (2009).</li><li>Cher, J. Z. B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Alarmins+in+Frozen+Shoulder:+A+Molecular+Association+Between+Inflammation+and+Pain.">Alarmins in Frozen Shoulder: A Molecular Association Between Inflammation and Pain.</a> Am J Sports Med. 46 (3), 671-678 (2018).</li><li>Wang, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Experimental+study+on+the+treatment+of+frozen+shoulder+in+rats+with+&amp;#34;C&amp;#34;+shaped+small+needle+knife.">Experimental study on the treatment of frozen shoulder in rats with &amp;#34;C&amp;#34; shaped small needle knife.</a> Hubei Uni Chinese Med. , (2020).</li><li>Bai, Y., Chen, B., Qin, Y. N., Du, Y. H. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Thoughts+on+constructing+the+core+outcome+index+set+of+clinical+research+on+frozen+shoulder.">Thoughts on constructing the core outcome index set of clinical research on frozen shoulder.</a> Chinese Med J. 36 (1), 69-73 (2019).</li><li>Buchbinder, R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+Preliminary+Core+Domain+Set+for+Clinical+Trials+of+Shoulder+Disorders:+A+Report+from+the+OMERACT+2016+Shoulder+Core+Outcome+Set+Special+Interest+Group.">A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.</a> J Rheumatol. 44 (12), 1880-1883 (2017).</li><li>Fan, Z. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+role+of+measurement+of+coracohumeral+ligament+thickness+in+diagnosis+and+evaluation+of+curative+effect+of+frozen+shoulder.">The role of measurement of coracohumeral ligament thickness in diagnosis and evaluation of curative effect of frozen shoulder.</a> Soochow University. , (2018).</li><li>Xiu, Z. B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Clinical+guidelines+of+small+needle+knife+for+knee+osteoarthritis.">Clinical guidelines of small needle knife for knee osteoarthritis.</a> J Rehabil. 33 (3), 193-201 (2019).</li></ol>

作者报告没有利益冲突。

在这项研究中，我们发现小针刀治疗显着缓解了I-II期肩周炎患者的疼痛症状，改善了肩关节功能，减少了CHL的厚度，并改善了生活质量。小针刀疗法对肩周炎有确切的效果。然而，手术地点是有争议的。由于知识背景不同，可以选择许多手术部位，用小针刀治疗肩周炎。主要手术部位是压痛穴、穴位和特定的解剖部位。因为治疗原理相似，无论选择什么手术部位，都能达到一定的治疗效果，但治...

肩周炎是一种以疼痛和主动和被动肩部运动受限为特征的疾病，对患者的工作和生活造成极大的不便1。全球肩周炎发病率在女性中为2%-5%2,3且高于男性，显示出一定的遗传趋势4。肩周炎患者多为40-60岁5.此外，肩周炎由于恢复周期较长且临床实践中缺乏既定的治疗共识，带来了沉重的社会负担。
肩周炎的主要治疗方法有口服或外用草药、针灸、按摩、功能锻炼等6;然而，由于治疗频率高、耗时较长，患者依从性较差，无法满足患者改善疼痛和功能受限的迫切需求。因此，迫切需要在肩周炎患者的临床管理中寻找更有效的治疗方法。
小针刀疗法是中医药的一种特殊而有效的外疗，近几十年来在中医药领域迅速兴起7。具有见效快、疗效明确、重复性高等优点。而且，操作仪器价格便宜，容易获得，操作过程简单，方法不受环境和条件的限制。小针刀治疗后患者的正常工作和生活不受影响，因为微切口会很快恢复，而不会对身体造成伤害，引起感染或其他副作用8,9,10,11。系统评价表明，小针刀治疗肩周炎的疗效明显优于针灸、按摩和口服中药12,13。现代研究表明，小针刀治疗肩周炎的机理是疏通经络和侧支，促进气血循环，切剥离病变组织，去除粘连，促进组织修复，恢复人体的动态平衡14,15。
这里介绍的方案演示了小针刀在治疗肩周炎中的操作，包括患者管理、材料准备、定位、手术和术后护理。该协议的目的是缓解肩周炎患者的疼痛和功能限制，提高其生活能力。
随着小针刀疗法的发展，其应用已从治疗颈、肩、腰、腿痛等肌肉骨骼疾病扩展到内科、外科、妇科、儿科等疾病，在康复医学领域发挥着越来越重要的作用16。近年来，由于超声引导小针刀可视化疗法的应用，小针刀显示出更加准确、科学和安全的治疗效果，其发展进入了一个新的阶段17,18。

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>Disposable sterile injection needle</td>
			<td>Shanghai Mishava Medical Industry Co., Ltd</td>
			<td>601900973</td>
			<td>Type specification:0.5 x 38 RWLB</td>
		</tr>
		<tr>
			<td>Disposable sterile small needle-knife</td>
			<td>Wujiang Yunlong Medical equipment Co., Ltd</td>
			<td>PR-4040</td>
			<td>Type specification:40 mm x 40 mm&#160;</td>
		</tr>
		<tr>
			<td>Disposable sterile syringe</td>
			<td>Shandong Weigo Group Medical polymer Products Co., Ltd</td>
			<td>601909174</td>
			<td>Type specification:10 mL</td>
		</tr>
		<tr>
			<td>Lidocaine hydrochloride</td>
			<td>Shanghai Hefeng Pharmaceutical Co., Ltd</td>
			<td>6904996104121</td>
			<td>Type specification:5 mL</td>
		</tr>
		<tr>
			<td>Marker pen</td>
			<td>Zebra Trading (Shenzhen) Co., Ltd</td>
			<td>4901681518111</td>
			<td>Type specification:1.0 mm/0.5 mm</td>
		</tr>
		<tr>
			<td>Sterile absorbent cotton ball</td>
			<td>Shanghai Honglong Medical Supplies Equipment Co., Ltd</td>
			<td>601905637</td>
			<td>Type specification:0.3&#160; 25 g</td>
		</tr>
		<tr>
			<td>Sterile disposable medical plastic cup</td>
			<td>Shanghai Honglong Medical Supplies Equipment Co., Ltd</td>
			<td>709008633</td>
			<td>Type specification:Waist-shaped disc</td>
		</tr>
		<tr>
			<td>Sterile dressing block</td>
			<td>Ningbo Haishu Shenyuan Medical Materials Co.,&#160; Ltd</td>
			<td>601909470</td>
			<td>Type specification:7.5 cm x 7.5 cm x 8 floors</td>
		</tr>
		<tr>
			<td>Sterile medical tweezers</td>
			<td>Shanghai Honglong Medical Supplies Equipment Co.,Ltd</td>
			<td>603917444</td>
			<td>Type specification:Small size</td>
		</tr>
		<tr>
			<td>Sterile rubber surgical gloves</td>
			<td>Guilin Hengbao health protection Co.,&#160; Ltd</td>
			<td>6971787071320</td>
			<td>Type specification:6.5</td>
		</tr>
		<tr>
			<td>Sterile self-adhesive dressing</td>
			<td>Shanghai ISO Medical Products Co., Ltd</td>
			<td>601909414</td>
			<td>Type specification:10 cm x 15 cm</td>
		</tr>
		<tr>
			<td>Sterile water for injection</td>
			<td>Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd</td>
			<td>6938493300953</td>
			<td>Type specification:5 mL</td>
		</tr>
		<tr>
			<td>Type II skin disinfectant</td>
			<td>Shanghai Likang Disinfection high-tech Co., Ltd</td>
			<td>6909157000359</td>
			<td>Type specification:500 mL/ bottle</td>
		</tr>
		<tr>
			<td>Ultrasound</td>
			<td>Suzhou Daer Medical Equipment Co., Ltd</td>
			<td>100018857</td>
			<td>uSmart3300 portable color ultrasound system</td>
		</tr>
	</tbody>
</table>

clinical efficacy of small needle knife therapy on stage i-ii frozen shoulder

肩周炎是一种由劳损、外伤等原因引起的肩部无菌性炎症性疾病，导致肩关节疼痛和功能受限。这里介绍的方案演示了小针刀治疗肩周炎的操作，包括患者管理、材料准备、定位、操作和术后护理。该协议的目的是缓解肩周炎患者的疼痛和功能限制，提高其生活能力。在我们的研究中，76 名符合纳入标准的 I-II 期肩周炎患者被随机分为对照组和治疗组 （n=38）。对照组患者接受功能性运动，治疗组患者接受小针刀治疗和功能性运动。评估超声下的视觉模拟评分 （VAS）、Constant 和 Murley 评分 （CMS） 以及喙肱韧带 （CHL） 的厚度。小针刀治疗后，治疗组VAS评分（5.11±0.89）显著低于对照组（5.49±0.65;t=-2.065，p<0.05）; 治疗组的CMS评分（64.72±4.78）显著高于对照组（60.97±6.00;t=2.947，p<0.05）; 治疗组（2.38 ± 0.36）的CHL厚度显著降低，而对照组（2.57 ± 0.42;t=-2.117，p<0.05）。 这些结果表明，小针刀显著缓解了疼痛症状，改善了肩部功能，减少了CHL厚度，提高了生活质量，因此在I-II期肩周炎患者中具有显著的治疗效果。

Frozen shoulder is a disease characterized by pain and limitation of active and passive shoulder movement, which causes great inconvenience to the work and life of patients1. The global incidence of frozen shoulder is 2%-5%2,3 and higher in females than in males, showing a certain genetic tendency4. The majority of frozen shoulder patients are 40-60 years old5. Moreover, the frozen shoulder brings about a heavy social burden due to the longer recovery cycle and the absence of established treatment consensus in the clinic practice.
The main treatment methods for frozen shoulders include oral or external use of herbal medicine, acupuncture, massage, functional exercise, and so on6; however, the compliance of the patients is poor due to the multiple treatment frequency and longer time-consuming, and cannot meet the urgent necessities of patients to improve pain and functional limitations. Therefore, it is urgently needed to identify more effective therapeutics in the clinical management of frozen shoulder patients.
Small needle knife therapy is a special and effective external treatment of traditional Chinese medicine, which has arisen rapidly in the field of traditional Chinese medicine in recent decades7. It has the advantages of quick effect, definite curative effect, and high repeatability. Moreover, the operation instrument is cheap and easy to obtain, the operation process is simple, and the method is not limited by the environment and condition. The normal work and life of patients are not affected after the small needle knife therapy since the micro-incision will be recovered quickly without damage to the body, causing infection, or other side effects8,9,10,11. Systematic reviews showed that the efficacy of small needle knife on frozen shoulder was significantly superior to acupuncture, massage, and oral Chinese medicine12,13. Modern studies show that the mechanism of small needle knife treatment of frozen shoulder is to dredge the meridians and collaterals, promote the circulation of qi and blood, cut and strip the lesion tissue, remove adhesion, promote tissue repair, and restore the dynamic balance of the human body14,15.
The protocol presented here demonstrates the operation of small needle knife in treating frozen shoulders including patient management, material preparation, positioning, operation, and postoperative care. The purpose of this protocol is to relieve the pain and functional limitations and improve the living ability of patients with frozen shoulders.
With the development of small needle knife therapy, its application has been extended from the treatment of neck, shoulder, waist, leg pain, and other muscle and bone diseases to internal medicine, surgery, gynecology, pediatrics, and other diseases, playing an increasingly important role in the field of rehabilitation medicine16. In recent years, the small needle knife shows a more accurate, scientific, and safe therapeutic efficacy due to the application of ultrasound-guided small needle knife visualization therapy, whose development has entered a new stage17,18.

作者聚焦：用小针刀疗法治疗肩周炎 

小针刀治疗I-II期肩周炎的临床疗效

Our study investigated the therapeutic efficacy of small needle knife in patients with frozen shoulders, and evidence that the improvement of pain function and the life ability. Our protocol addresses the detailed operation process of small needle knife in frozen shoulder patients. Our protocol has the advantages of quicker and definite therapeutic effects, high repeatability, broader availability, also there are less physical injury in patients.

对照组1例患者因疼痛加重而接受其他治疗（关节内类固醇注射），故终止试验，对照组其余37例患者纳入最终统计分析。对于治疗组2例超声检测不到CHL的患者，因此取消了检测，治疗组其余36例患者进入最终统计分析。
基线特征 两组患者在性别、年龄、患侧、病程和分期方面的差异相当（p > 0.05）。对照组男性13例，女性24例，治疗组男性19例，女性17例?...

Watch this Scientific Journal Video about Treating Frozen Shoulder with Small Needle Knife Therapy at JoVE.com

这里介绍的方案描述了详细的手术方法，并证明了小针刀治疗肩周炎的有效性。

Frozen shoulder is a kind of aseptic inflammatory disease of the shoulder caused by strain, trauma, and other reasons, resulting in shoulder joint pain ...

本研究调查了小针刀对肩周炎患者的治疗效果，以及改善疼痛功能和生活能力的证据。我们的方案解决了肩周炎患者小针刀的详细操作过程。我们的方案具有更快和明确的治疗效果、高可重复性、更广泛的可用性以及患者身体伤害更少的优点。

clinical-efficacy-small-needle-knife-therapy-on-stage-i-ii-frozen

Research

JoVE Journal

Medicine

Clinical Efficacy of Small Needle Knife Therapy on Stage I-II Frozen Shoulder

957 次观看.  Shanghai University of Traditional Chinese Medicine. 本研究调查了小针刀对肩周炎患者的治疗效果，以及改善疼痛功能和生活能力的证据。我们的方案解决了肩周炎患者小针刀的详细操作过程。我们的方案具有更快和明确的治疗效果、高可重复性、更广泛的可用性以及患者身体伤害更少的优点。