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求翻译：Previous research shows that asymmetric information triggers a decrease是什么意思？
Previous research shows that asymmetric information triggers a decrease
问题补充：
以往的研究表明，减少信息不对称引发
以前的研究表明,减少信息的不对称将导致
正在翻译，请等待...
先前的研究显示的信息不对称触发减少
上一步调查显示不对称的信息触发减少
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请输入您需要翻译的文本！当前位置： &
求翻译：以往研究表明（吉林省地质局，1979），该旱玛珥由上至下的沉积层序如下：（1）草根层，厚度约20-30 cm，由植物根及未分解的植物残体组成；是什么意思？
以往研究表明（吉林省地质局，1979），该旱玛珥由上至下的沉积层序如下：（1）草根层，厚度约20-30 cm，由植物根及未分解的植物残体组成；
问题补充：
Previous studies have shown (Jilin Province, Geological Bureau, 1979), the sedimentary sequence of the Maar from top to bottom as follows: (1) grass-roots layer thickness of about 20-30 cm by the plant roots and undecomp
Previous studies have shown that (geological, Jilin Province, 1979), the ecological communities of the layer of sediment sequence is as follows: (1) grass-roots level, the thickness is approximately 20 - 30 cm, with plant roots and not break do
Formerly studied indicated (Jilin Province geology bureau, 1979), this dry Masurium arc of contact of halo top-down sequence of sedimentation was as follows: (1) stock level, thickness approximately 20-30 cm, and the decomposition plant remains has not been compos
Previous studies have shown that (Jilin provincial Bureau of geology, 1979), dry Maar from top to bottom in the sedimentary sequence is as follows: (1) grass-roots level, the thickness of about 20-30 cm, by plant roots and are not composed of decomp
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请输入您需要翻译的文本！每周一译 | 干针联合物理疗法和康复训练治疗非特异性的慢性机械性肩痛_突袭网
当前位置&:&&&&每周一译 | 干针联合物理疗法和康复训练治疗非特异性的慢性机械性肩痛
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每周一译 | 干针联合物理疗法和康复训练治疗非特异性的慢性机械性肩痛
编辑：张俊评论：
干针联合物理疗法和康复训练治疗非特异性的慢性机械性肩痛的随机对照试验
肌肉骨骼引起的肩部疼痛是造成非创伤性的上肢疼痛的主要原因。尽管是最常见的咨询原因之一，但由于其病因的复杂性，目前还没有既定的治疗方案。然而，有证据显示肩痛患者通常在肩部肌肉存在激痛点。我们创建了一个设计方案来描述一组随机对照试验，用来评估用包含干针的人工物理治疗和治疗性锻炼治疗非特异性慢性肩部疼痛的有效性。
招聘36名年龄在18 - 65岁之间符合纳入标准的由不明原因引起的无意识的慢性肩痛患者。参与者被随机的分为两组，(i)干针、物理治疗和康复训练或者 (ii)假干针、物理治疗和康复训练。治疗时间为6周，6个月之后随访。主要观察指标为疼痛视觉模拟量表。
这是第一个结合使用干针、物理治疗和康复训练的并且有6个月随访的研究,因此成为治疗慢性肩痛的新贡献,并且可以建立研究的新线路来帮助确定干针对慢性肩痛的效果、频率和适当的剂量。
试验注册：
国际标准随机对照试验数字编号:
ISRCTN(http://www.controlled-trials.com)日。
干针，肩痛，物理治疗，康复训练，激痛点。
肩痛是一种常见的肌肉骨骼问题，每年的发病率为20%到50%，是造成非创伤性上肢疼痛的主要原因。它表现出高度的慢性和复发[2]，40%-50%的患者症状持续6到12个月[2]。然而，对于肩痛的临床定义没有标准[3]。
临床试验倾向于使用非特异性肩痛这一术语，因为缺乏对诊断标准的一致性，缺乏临床证据的特异性，多肩病的共存，缺乏任何被认为是“金标准”的诊断试验[4]。最常见的体征和症状在三角肌、前臂和肩部均有，表现为肩部僵硬，运动范围受限[5]，从而导致日常生活活动受限[6]。
肩峰撞击综合症在基层是最常见的诊断[7 - 9]，虽然认为它是导致肩部疼痛的原因，但没有确凿的证据来支持这一说法。此外，在健康的受试者和有肩痛的受试者中，钙化、骨刺、肩袖下的水肿、肩袖的退行性损伤、肌腱炎症和退化在健康者和肩痛患者中都很普遍，所以只有诊断不能证明症状的存在。
此外，在肩部肌肉存在激痛点(MTrPs)是肩痛患者的常见症状[3]，可能在肌肉拉伸、收缩或压迫时引起疼痛。这些MTrPs是紧绷的骨骼肌群上的过敏性点，MTrPs可引起按压痛、运动障碍和牵涉痛。
现已知总共有17块肌肉会重现类似于其他痛苦的肩膀综合症的症状 ，包括休息、运动和睡眠障碍(1,13,14)。因此，激痛点的存在被认为是对肩痛的一种替代解释，无论是否存在肩峰下疾病[1,14]。
肩痛通常首选保守治疗，如休息、物理治疗、抗炎药(NSAIDs)和皮质类固醇注射[15,16]。然而，目前已有研究表明联合多种疗法治疗肩痛的疗效，包括干针、拉伸、物理治疗、动员技术、冷敷、家庭锻炼、激痛点的缺血压缩和符合人体工程学的建议[1,17]。
治疗方法的选择通常是主观的，取决于治疗师的技能和训练，然而康复训练联合物理疗法通常有好的疗效[5,18]。Kietrys等[5]最近的一项Meta分析[5]表明与安慰剂组比较干针可减少疼痛，在治疗后和四周后随访上象限肌筋膜疼痛综合征患者。然而，我们需要新的研究来支持这一推论。
有人建议，干针结合物理疗法可改善术后患者肩痛程度以及肩部运动范围[19]。然而，我们还没有发现关于非特异性慢性肩痛患者的类似研究。
因此，本研究的主要目的是确定干针联合物理治疗和康复训练治疗非特异性慢性肩痛的临床疗效。我们的假设是，干针联合物理疗法和康复训练可减轻肩痛患者的症状以及改善肩痛患者的功能。
这是一个随机对照平行单盲试验。这项研究是在国际标准随机对照试验号(ISRCTN)注册的，并符合《2013年精神宣言》的建议。
参与者被随机分配，接受真实的或者假的干针针刺。通过计算机生成的随机数序列来分组。分配序列是由一名不相干的物理治疗师创建并执行的，负责电话筛选和处理在各种评估中获得的数据。
图1显示了该测试各个阶段的进度流程图。这项研究得到了阿尔卡拉大学人类研究委员会的批准(Reference:CISM /HU/2015/ 19)。
来自Alcala de Henares(马德里)，年龄在18到65岁之间患有非特异性慢性机械性损伤肩痛的患者，疼痛持续至少3个月，并且假设他们在被告知参与研究后得到他们的同意。通过电子邮件给阿尔卡拉的工作人员和学生招募参与者，并将海报张贴在Alcala de Henares市附近的一些社会和体育中心以提供研究和联系信息。随后，第一次电话采访旨在解释受试者的任何疑问，并进行第一次纳入研究的筛选。
受试者的个人资料将被编码并储存在一个计算机数据库中，该数据库只能由负责参与随机化和致盲的物理治疗师访问。
将知情同意书，以及所有研究信息通过电子邮件发送给受试者。随后，在数据收集和基线测量之前，参与者应该签署知情同意，受试者在治疗期间可随时退出。
非特异性的慢性机械性肩痛持续至少3个月。
年龄在18到65岁之间。
在肌肉中出现活跃的触发点或机械高度敏感区域(上斜方肌，冈下肌，肩胛下肌和中三角肌)，并在一个或多个肌肉中产生疼痛。
参与者将由一个有超过10年治疗激痛点经验的临床医生检查肌群中是否有活跃的触发点。激痛点的诊断满足下列标准:[1]在明显的紧绷带中有高度敏感点，[2]触摸激痛点显而易见或局部出现痉挛，[3]触摸敏感点可出现牵涉痛。当一个有经验的评估者应用这些标准是可确保可靠性[20]。
之前做过肩部手术。
既往有肩部脱臼病史。
神经根型颈椎病。
患有纤维肌痛。
针刺恐惧症或任何对干针刺的禁忌(例如抗凝血剂或精神障碍)。
两侧肩痛。
在过去的6个月里接受干针治疗。
目前正在接受肩痛的其他物理治疗。
这项研究有7名理疗师；1名有10年使用干针治疗激痛点的临床治疗师，2名评估者和2名物理治疗师对受试者进行物理治疗和康复训练，1名理疗师负责面试,初步筛选和受试者分组,1名位理疗师负责统计分析。
疼痛作为研究的主要观察指标。认为效应值TE = 0.25[21]。假设重复测量的测量值为0.5。假设在干针刺和术后一周6次测量的基础上，1周，1个月，3个月，6个月，2个治疗组，球度校正将在0.5。统计功率为0.95,alpha水平为0.05，总样本量为28人，因考虑到25%的脱落率，一共需要36名患者，两组均为18例，使用Gpower 3.0.18软件[22]。
随机和盲法
在基线时，不干涉的物理治疗师，通过随机分配软件，用排列区组随机分配[4,8]，5名物理治疗师实施36名受试者的相关治疗。负责操作干针的物理治疗师——可能是A(实验组)或B(对照组)，2组物理治疗师，G1和G2，每组都有一个评估者和治疗师。4个可能的治疗组(AG1,AG2,BG1,BG2)将被平均分配到每个随机组。
通过电话筛选的参与者依据随机化表格将随机的分配一个数字;治疗组(A或B)和物理治疗师组(G1或G2)是指定的。理疗师负责干针治疗，同时给理疗师提供每个受试者的名字以及受试者接受何种治疗方案。
在第一次治疗时，每个参与者接受真干针或假干针治疗，这是由一名具有十年以上激痛点治疗经验的物理治疗师进行。物理治疗师不知道参与者的基线资料数据。另一方面，评估参与者和进行物理治疗及康复训练的理疗师都不知道参与者的基线资料。
此外，在评估期间收集的数据将不会向实施治疗的物理治疗师透露，进行第一次干针治疗的受试者不公开他们的感受和相关信息。
最后，对统计分析负责的物理治疗师都对参与者不知情。一旦干预完成，他将获得一个包含二进制代码的所有必要数据的excel数据表。
本次研究的参与者将接受6次治疗(每周1次)，并在每次治疗开始前进行相应的评估。另外，在完成最后一次治疗后，评估参与者治疗一周、一个月、三个月、六个月后的情况。
干针治疗激痛点
为了完成干针针刺过程，病人应被放置在:他们的健康或良好的一侧，为冈下肌和三角肌;下肩胛下肌的上斜方肌的下斜肌。物理治疗师治疗位于肌肉上的每一个激痛点:上斜方肌、冈下肌、肩胛下肌和中三角肌。
然后,使用0.30 x40mm针(AGU-PUNT APS)刺入肌肉。使用“快进快出”手法把针刺入和拔出肌肉[23]。每块肌肉上针刺操作重复12次，干针操作类似香港的针灸操作(23,24)。针刺每个肌肉上最明显的激痛点。如果触摸肌肉时没有发现MTrP，则不需要在肌肉上进行治疗。
同时,对照组将接受相同的治疗,但使用0.30 x30mm假针(Asiamed Streitberger安慰剂——针),之前在另一项研究中已使用[25]。
两组参与者接受相同的干针治疗过程的感受。接受治疗之前，他们被告知他们可能感觉到或感受不到针刺入皮肤。这跟针刺的部位和受试者的敏感性有关。然后，他们会感到物理治疗师反复地进行针刺操作。此外，治疗过程中参与者应与理疗师交流针刺感受。
物理疗法和康复训练
先前的研究表明，物理疗法联合康复训练比单独的训练在减少疼痛、增加关节活动范围、改善力量和功能等方面更有效[26,27]。然而，没有证据表明一种训练模式优于另一种，也没有证据表明最佳训练频率和强度[27]。
治疗过程由两名物理治疗师实施，分为两部分;第一部分使用手法治疗受影响的肩痛，第二部分基于治疗性锻炼。另外，参与者将被指定治疗性家庭锻炼，每周两次(隔日)。
物理治疗持续大约45分钟。治疗方案选用先前的研究中使用的操作，,例如触发点压力释放[28],纵向按摩[28],活动肩关节,活动盂肱关节,盂肱滑翔不紧密接触和主动活动(34、35)。表1描述了具体操作过程。
监督的治疗训练持续大约25分钟，分为3个渐进性治疗阶段，每阶段2周。选用先前的研究中使用的锻炼,如肩关节稳定运动、关节囊,科德曼运动[26],本体感受,积极自学肩部练习[26],加强肩袖和肩胛肌肉的训练。锻炼的描述和剂量见表2。
在家的治疗性锻炼将持续15到20分钟左右。每周进行两次(隔日)，在治疗过程中理疗师提供指导和训练。
如上所述训练将分为3个阶段，并遵循每项锻炼的相关说明。在每次治疗时询问的家里锻炼情况，了解遇到的任何困难，并作必要的修正。干预完成要求参与者继续在家进行治疗性锻炼直到最后一次评估(治疗后6个月)。
在研究干预期间，参与者不能接受任何物理治疗或药物。如果在研究期间发生任何不良事件，或在研究的任何时候，参与者将停止参与。
在基线测量期间，将收集以下描述性特征:(i)性别，(II)年龄，(III)体重，(IV)身高(V)惯用手，(VI)当前职业，(VII)运动。此外，还要收集下列有关受影响肩痛的信息:(i)疼痛侧，(II)疼痛持续时间，(III)既往病史，(IV)服药。主要和次要的测量结果如表3所示。
主要结果测量
这项研究的主要通过视觉模拟量表(VAS)评估肩痛程度。参与者在一条100m的线上标注他们疼痛的程度，0分表示无痛，10分表示最痛。,VAS已经证明了检测疼痛变化的能力，在13毫米(41,42)的临床意义上有显著差异。在治疗肩袖疾病的患者中，14毫米的差异[43]。
次要结果测量
1 .手臂，肩膀和手的残疾(DASHe)，西班牙版本。它将用于确定与肩痛有关的伤残率。DASHe是一份自我管理的问卷，由30个项目的中心机构和2个可选模块组成，每个模块有4个项目，旨在通过演奏乐器和表演体育或工作来衡量上肢受伤的影响。每一项的得分都是1到5，随着症状的严重程度的增加，分值也会增加。这些项目的分数相加得到总分，可以从30分到150分，从0(最好的可能的分数)转换到100(最糟糕的可能分数)。
如果有可选模块，也是用同样的方法单独得分。DASHe调查有4个及以上未回答的问题则问卷无效。DASHe调查表允许评估病人进行各项活动的感知残疾，包括日常生活的活动和诸如疼痛、僵硬和力量丧失等症状[44]。在成人肌肉骨骼上肢的DASHe的最小显著的是10.2[45]。
2.压力痛阈(PPT)。在最严重的机械痛觉过敏患者的肩膀,棘突的C7和胫骨前的最大的机械痛觉过敏区域执行压力痛觉计(基线30公斤)。PPT的定义是在一个痛苦的感觉出现之前，需要评估的压力值。进行三次测量并计算平均值，用于数据分析。在测量之间要留出30秒的休息时间。C7和胫前测量将用于确定肩部疼痛的中枢调节作用[28,46]。
已经确定，如果考官受过良好的训练，痛觉测量是一种非常可靠的PPT测量技术。切斯特顿等[47]表示，可以肯定地认为，大于17.39 N/ cm2(1.77 kg/ cm2)的变化可以代表真正的变化。在一个月的随访[28]中，使用了痛觉测量法测量了手法治疗对肩部疼痛的触发点的治疗效果。
3 .肩关节的活动范围。用标准18厘米的塑料测角仪(萨蒙斯Preston-Rolyan)测量。以下肩膀运动将被测量:屈肌，伸展，内旋，外旋和外展，一直到不疼痛的范围。每一个运动测量三次，计算平均值用于分析。
通用测角仪显示了良好的可靠性(内相关系数从0.91到0.99)，如果使用一致的基准测试[34]，则为屈曲、伸展、外展和旋转[48]。需要6°到11°活动范围来确定肩部测量的真正范围[34]。
测量屈曲的活动范围受试者采用坐位，腹部和椅背有带子环绕，限制躯干活动的代偿。测角轴与关节轴的中心(在肩峰下外侧)对齐。角度仪的固定臂会跟随躯干的线，和移动臂，与肱部的纵轴平行，它将积极地抬起手臂在矢状面;大拇指指向上方[34]。
测量伸展运动范围，参与者采用俯卧位;肩膀的中立立场,肘部弯曲90°和前臂在中立位置。角度仪轴将被放置在盂肱关节的侧面的中点上。固定臂与病人的躯干平行，移动手臂平行于肱部纵轴。最后，手臂会在矢状面积极伸展[34]。
对于外展运动，参与者采用坐位，用皮带绕着腹部和椅背，以限制躯干补偿。测角轴位于肩关节后部的中点。固定臂与躯干平行，移动臂平行于肱部纵轴。最后，手臂在正面的平面上被积极地绑架，大拇指向上指向以允许必要的外部旋转[34]。
测量肩关节内旋活动范围参与者采用俯卧位；90°的肩膀外展,90°屈肘和前臂在中立位置。为了避免代偿活动，将拇指放在喙突上施加压力，其余手指放在肩胛骨的脊柱上，以控制肩胛骨上提。角度仪轴将与肘部鹰嘴对齐。固定的手臂将直立，垂直于地板，而角度仪的移动臂将沿着前臂的中线排列。最后进行内旋[34]。
参与者仰卧进行外旋;臀部和膝盖弯曲45°，肩90°外展，屈肘90°并且前臂中立。角度仪轴将与肘部鹰嘴对齐。固定的手臂垂直于地板，移动手臂在前臂的中线对齐，最终进行外旋[34]。
4.肩部活动力量。使用手测力仪测量(microFET2霍根科学LLC)。测量值将以磅数换算成千克-力。下列运动的强度将被测量:弯曲、外展、外旋和内旋。
为了测量ER(外旋)和IR(内旋)的等距力，我们发现，它的内部相关系数(ICC)是0.93到0.99。最小可检测的变化从7.87 N(外旋)到22.11 N(内旋)[48]。
理疗师应在执行测试时被另一人或用带子固定住手或肩、肩胛骨和躯干。测量弯曲的强度将与参与者进行坐姿与肩部在45°的弯曲和肘部延伸;测力计将放在外侧上髁上。箱子将被捆住，以避免躯体代偿活动[49]。外展与参与者进行坐姿90°的肩膀外展,90°屈肘和前臂中立,定位测功器只是近端外侧上髁[50]。
测量肩关节的内旋力量受试者采用仰卧位；肩外展，90°屈肘和前臂中立。该测力计将停留在前臂的腹侧，2厘米的近端到茎突[48]。对于外部旋转测量，参与者仰卧；90°的肩膀外展,90°屈肘和前臂中立。该测力计将在前臂的后部，2厘米的近端到茎突的过程[48]。
在执行基线测量时，也会收集参与者健康方面的次要结果测量数据，以确定在开始干预之前是否有基线差异。
理疗师培训
在开始研究之前会实施一系列的评估和治疗的培训，目的是为了对研究中实施的行动进行原型化。在这些训练阶段，将实施治疗技术和测量，以便在相关的物理治疗师之间达成共识。此外，外部观察者也会重视物理治疗师之间的干预。
数据分析将按照与对照组实验研究设计的评价标准进行。实验组(干针+物理治疗和康复训练)将与对照组比较(假干针刺+物理治疗和康复训练)。
使用SPSS v22 Windows软件进行数据。采用95%的可信区间(p值& 0.05)，以确定两种干预方法的有效性。在统计比较之前分析所有数据，以确定夏皮罗-威尔克检验法测试的正常分布。随后，对两个干预组的同质性进行研究，使用t检验的独立样本数据，以符合正常的数据和mann - whitney检验数据。性别变量将研究通过皮尔森χ2或确切概率法,如果是前者无法使用。然后对相关变量的数据进行描述性分析。在这些分析中，将计算出正态分布的因变量的均值和标准差(SD)。对于不符合正常的变量，数据将用中位数和第一和第三个四分位数表示。
在组间比较中，我们可以找到一个“差”的变量;对于每一个因变量，减去基线测量值——在针刺后的一个星期，基线-后1周，基线-后1个月，基线-后3个月和基线-后6个月(对于DASHe变量，测量在针刺一周后不会被收集)。
对于VAS变量，将在基线-第2周、第3周、第4周、第5周、第6周之间找到“差异”变量。确定两干预组之间因变量的差异,t检验适用于相关样本变量的遵循正常概率的数据,在这种情况下,影响大小将根据公式d = 2 t / g√计算。在数据不符合正常的变量情况下，将进行mann - whitney测试的分析，并根据Grissom程序对估算效应值。
本方案将进行随机的单盲临床试验，旨在研究干针联合物理疗法和康复训练对非特异性慢性机械性损伤肩痛患者的疼痛改善和致残是否有更好的疗效。
慢性肩痛是一种复杂的痛苦状态，没有明确的临床定义[3]，其高复发和持续的症状[1,2]，使其难以选择最适当的治疗。此外，有证据表明肩关节周围的激痛点和疼痛之间存在相关性[1,3,13,14]，因此这类患者可通过治疗肌肉而缓解疼痛。
此外，先前的研究已证明物理疗法联合康复训练治疗肩痛是有疗效的，尽管治疗的最佳频率和程度仍然不明确。[5,17]。在上象限肌筋膜疼痛综合征患者中建议使用干针[4]，而在手术后肩部疼痛的病例中，观察到单次干针的好处[19]。
此外，使用康复训练治疗肩关节疼痛的病例(26,36)显示有效，包括它们在执行本方案的重要性，不仅在治疗期间，而且在家里也有效。在本方案包含的练习中，肩胛的训练是一个基本的方面，因为观察到肩关节疼痛的患者在训练之后其肩胛下肌和下斜方肌的肌电图激活程度呈减少，以及上斜方肌的更大的活化，反映在肩胛肱骨上的肌肉不平衡[36]。
因此，依据相关文献，我们选择了不同的物理治疗方法和康复训练，以建立干预方案，其中还包括一组干针刺或假干针，以研究其潜在的好处。由于这些方法副作用少，成本效益更低，相比较手术和短效作用的药物它可能是更有利的干预措施的替代疗法。
因此,由于缺少类似非特异性慢性肩痛患者的研究、这项研究的实施和其结果的公布将对慢性肩痛的治疗做出新的贡献,并可能在研究干针对慢性肩痛患者的疗效和确定治疗方法的最佳频率及强度方面建立新的研究线路。
原文链接：
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.-017-1746-3
Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial
Background: Shoulder pain of musculoskeletal origin is the main cause of upper limb pain of non-traumatic origin.Despite being one of the most common reasons for consultation, there is no established protocol for treatment due to the complexity of its etiology. However, it has been shown that the presence of myofascial trigger points on the shoulder muscles is a common condition associated with patients suffering from shoulder pain. This protocol has been created which describes the design of a randomized controlled trial to evaluate the effectiveness of the
inclusion of dry needling (DN) within a protocol of manual physiotherapy and therapeutic exercise in the treatment of chronic shoulder pain of unspecific origin.
Methods: Thirty-six participants aged 18–65 years will be recruited having mechanical chronic shoulder pain on unspecific origin and meeting the inclusion criteria. These will be randomized to one of two interventions, (i) DN, manual physiotherapy and therapeutic exercise or (ii) sham DN, manual physiotherapy and therapeutic exercise. The protocol will cover 6 weeks of treatment, with a 6-month follow-up. Our main outcome measure will be the Visual Analogue Scale for pain.
Discussion: This is the first study to combine the use of DN, manual physiotherapy and an exercise program with a 6-month follow-up, thus becoming a new contribution to the treatment of chronic shoulder pain, while new lines of research may be established to help determine the effects of DN on chronic shoulder pain and the frequency and proper dosage.
Trial registrations: International Standard Randomized Controlled Trial Number Register: ISRCTN (http://www.controlled-trials.com) 29 June 2016.
Keywords: Dry needling, Shoulder pain, Physical therapy, Therapeutic exercise, Myofascial trigger point.
Background
Shoulder pain is a common musculoskeletal problem, with an annual prevalence of 20 to 50%, being the main cause of non-traumatic upper limb pain. It presents a high chronicity and recurrence [1] and the symptoms persist for 6 to 12 months in 40 to 50% of patients [2]. However, there is no standard for the clinical definition of shoulder pain [3].
Clinical trials tend to use the term nonspecific shoulder pain due to the lack of agreement on diagnostic criteria, lack of specificity of clinical evidence, coexistence of multiple shoulder pathologies and lack of any diagnostic test that is considered a “gold standard” [4]. The most common signs and symptoms are localized in the deltoid, forearm and shoulder region, presenting shoulder stiffness and limited range of motion [5] which restrict daily living activities [6].
Shoulder Impingement Syndrome is the most common diagnosis in primary care [7–9] and although it is believed to be the cause of shoulder pain, there is no solid evidence to support this. Furthermore, the presence of calcifications, acromial bone spurs, subacromial swelling, degenerative rupture of the rotator cuff, tendon inflammation and signs of degeneration are prevalent in both healthy subjects and in subjects with shoulder pain [10–12] so its diagnosis alone would not justify the presence of symptoms.
Moreover, it has been shown that the presence of myofascial trigger points (MTrPs) in the shoulder muscles is a common condition in patients with shoulder pain [3], and may cause pain during muscle stretching, contraction or compression. These MTrPs are hyperirritable points in taut bands of skeletal muscle and are painful to compression, producing motor dysfunction and referred pain [13].
As many as 17 muscles are known to reproduce similar symptoms to those of other painful shoulder syndromes, including pain at rest, upon movement and sleep disorders [1, 13, 14]. Therefore, the presence of MTrPs has been suggested as an alternative explanation for shoulder pain, regardless of the presence of subacromial disorders [1, 14]. Treatment of shoulder pain usually begins with conservative therapies such as rest, physical therapy, anti-inflammatory drugs (NSAIDs) and corticosteroid injections [15, 16]. However, current studies have shown the benefits of a multimodal treatment for shoulder pain including techniques such as dry needling, stretching, manual therapy, mobilization techniques, applying cold, home exercise, ischemic compression of MTrPs and ergonomic recommendations [1, 17].
The choice of treatment is often subjective and depends on the therapist’s skill and training, while therapeutic exercise programmes in combination with manual therapy techniques often show good results [5, 18]. A recent meta-analysis by Kietrys et al. [5] recommends using dry needling, compared against placebo, to reduce pain, following treatment, and at 4 weeks follow-up in patients with Myofascial Pain Syndrome of the Upper Quadrant. However, new studies to support this recommendation are required.
It has been suggested that the inclusion of dry needling, in a single session, within a multimodal physiotherapy programme for patients with post-surgery shoulder pain, produces improvements in on and range of motion [19]. However, we have not found similar studies in patients with chronic shoulder pain of unspecific origin.
Therefore, the main aim of this study is to determine the effectiveness of including dry needling in a manual physiotherapy and therapeutic exercise programme, for the treatment of chronic shoulder pain of unspecific origin. Our hypothesis is that by including a single session of dry needling in a manual physiotherapy and therapeutic exercise programme, treatment outcomes improve, reducing symptoms and improving function in patients with shoulder pain.
Study protocol for a randomized controlled parallel group single-blind trial. This study was registered with the International Standard Randomized Controlled Trial Number (ISRCTN) and complies with the recommendations of The SPIRIT 2013 Statement.
Participants will be randomized to receive dry needling, either real or sham. Allocation to either group, namely real or sham dry needling, will be achieved through a computer-generated sequence of random numbers. The allocation sequence is created and carried out by a non-interventionist physiotherapist, in charge of telephone screening and of handling the data obtained in the various assessment sessions.
Figure 1 shows a flowchart of the progress of the various stages of this test. This study was approved by the Committee on Human Research, Universidad de Alcalá (Reference: CISM/HU/2015/19).
Participants
From the town of Alcalá de Henares (Madrid), aged between 18 and 65 years with chronic mechanical shoulder pain of unspecific origin, lasting at least 3 months and provided they give their consent after being informed about participation in the study. The recruitment of participants will be conducted via email for University of Alcalá workers and students and by placing posters in a number of social and sports centres around the city of Alcala de Henares, where information about
the study and contact information will be provided. Subsequently, a first telephone interview will be conducted to clarify any doubts of the participants, and the first screening for inclusion in the study will be carried out.
Participants’ personal data will be numerically coded and stored in a computer database, which may only be accessed to by the physiotherapist in charge of participant randomization and blinding. Informed consent, as well as all study information will be emailed to the participants. Subsequently, prior to data collection and baseline measurement, participants should sign the informed consent, which could be revoked at any time during the intervention.
Inclusion criteria:
Chronic mechanical shoulder pain of unspecific origin lasting at least 3 months.
Aged between 18 and 65 years.
Presence of active trigger points or areas of mechanical hypersensitivity in the muscles to be treated (upper trapezius, infraspinatus, subscapularis and middle deltoids) with pain reproduced in one or more muscles.
Participants will be examined for the presence of active trigger points in the muscles selected by a clinician with more than 10 years of experience in the treatment of MTrPs. Diagnosis of MTrPs will be determined by the presence of the following criteria: [1] hypersensitive point in a palpable taut band, [2] visible or palpable local spasm in response to MTrP palpation, and [3] reproduction of referred pain by palpation of the sensitive spot. These criteria have shown good interexaminer reliability (κ, kappa between 0.84 to 0.88) when applied by an experienced evaluator [20].
Exclusion criteria:
Previous surgery on the shoulder.
Previous history of shoulder dislocations.
Cervical radiculopathy.
Diagnosis of fibromyalgia.
Needle phobia or any contraindication to dry needling
(e.g. anticoagulants or psychiatric disorders).
Bilateral shoulder pain.
Pregnancy.
Having received dry needling in the last 6 months.
Currently receiving other physiotherapy treatment for shoulder pain.
Research team
This study will involve 7 1 Clinical physiotherapist with more than 10 years of experience in the use of dry needling for MTrP treatment, 2 evaluator physiotherapists and 2 physiotherapists responsible for carrying out the manual physiotherapy and therapeutic exercise treatment of the participants, one physiotherapist responsible for the interview, initial screening and randomization of participants, and one physiotherapist who will perform the statistical analysis.
Sample size
The pain variable is chosen as the primary measurement of the study results. An effect size TE = 0.25 will be considered [21]. A correlation between repeated measures of 0.5 shall be assumed. Assuming the performance of 6 measurements -basal and a week after the dry needling, and posttreatment: at one week, at one month, at 3 months and at 6 months- in two treatment groups, sphericity correction will be determined at 0.5. With a statistical power of 0.95, with an alpha level of 0.05, a total sample size of 28 patients is estimated, and taking into account 25% for losses, a total of 36 patients needs to be reached, being 18 in both groups, using the Software Gpower 3.0.18 [22].
Randomization and blinding
At baseline, the non-interventionist physiotherapist, through the Random Allocation Software, will randomize by permuted blocks [4, 8], the participation of the 5 intervening physiotherapists with respect to a sample of 36 participants. The physiotherapist in charge of performing dry needling –which may be A (experimental) or B (control)- and 2 groups of 2 physiotherapists, G1 and G2, with an evaluator and a therapist in each group. 4 possible treatment groups (AG1, AG2, BG1, BG2) will be obtained evenly in each randomization block.
Participants who successfully pass the phone screening will be assigned a number on the randomization table in order of in the treatment group (A or B) and physiotherapist group (G1 or G2) in which they will be included are specified. The physiotherapist responsible for carrying out the dry needling, will provide a list with the names of the participants, showing the type of intervention that each will receive (A or B).
Each participant will receive a single dry needling or sham dry needling intervention at the start of the first treatment session, conducted by a physiotherapist with more than 10 years of experience in MTrP treatment with dry needling. Said physiotherapist will be blinded to the baseline data of participants. On the other hand, both the physiotherapists who evaluate the participants and those who perform manual physiotherapy treatment and therapeutic exercise, will be unaware of the group of each participant.
In addition, data collected during the assessment of participants will not be revealed to the physiotherapists who perform the treatment, and participants will be instructed not to disclose their experience and information related to the first treatment session of dry needling.
Lastly, the physiotherapist responsible for the statistical analysis will be blinded. Once the intervention is finished he will receive a data table in excel with all the necessary data in binary code.
Interventions
Participants included in this study will receive 6 treatment sessions (one per week), with a corresponding evaluation before the start of each treatment session. In addition, the participants after completing the last treatment session, will receive post-t at one week, at one month, at 3 months and at 6 months.
Dry needling of myofascial trigger points
To perform the dry needling procedure, patients should be placed on: their healthy or good side for infraspinatus supine decubitus for
and prone decubitus for upper trapezius muscle. The physiotherapist will treat each MTrP that have previously been located in the muscles: upper trapezius, infraspinatus, subscapularis and middle deltoid.
After this, a 0.30x40mm monofilament needle (AGU-PUNT, APS?) will be inserted towards the muscle mass. Said needle should be inserted into and extracted from the muscle using the “fast in and fast out” technique [23]. Needle insertion will be repeated 12 times in each muscle, the dry needling procedure being similar to that used by Hong [23, 24]. At most one MTrP (the one producing most pain) in each of the muscles will be needled. If no MTrP is found during muscle palpation, the needling procedure will not be performed on that muscle.
Meanwhile, the control group will receive the same treatment but using 0.30x30mm sham needles (Streitberger Placebo - needle?, Asiamed), which have been used before in another study [25].
Participants in both groups, will receive the same information about the sensations of dry needling procedure. They will be informed, at the beginning of the technique,that they may or may not feel the introduction of a needle through the skin. This will be related to the area of the body where the puncture is performed and according to the sensitivity of the subject. Afterwards, they will feel as the physiotherapist manipulates the needle with his hand repeatedly. In addition, participants should communicate to the physiotherapist the sensations they notice during the performance of the technique.
Manual physiotherapy and therapeutic exercise programme
Previous studies have shown that the inclusion of manual physical therapy in an exercise programme is more effective than exercise alone in reducing pain, increasing range of motion, strength and functionality [26, 27]. However, evidence has failed to show if an exercise mode is better than another, or which are the optimal frequencies or intensities thereof [27].
Treatment sessions will be implemented by two physiotherapists and di the first part will be based on manually treating the affected shoulder and the second part will be based on supervised therapeutic exercise. In addition, participants will be prescribed therapeutic home exercises, twice weekly (alternate days).
Manual physiotherapy treatment will last approximately 45 min. Techniques used in previous studies have been chosen for the treatment protocol, such as trigger point pressure release technique [28], longitudinal massage [28], scapulohumeral mobilization [19, 29], glenohumeral mobilization [19, 30], glenohumeral gliding and gapping [31–33] and mobilizations with active movement [34, 35]. The deion and dosage of the techniques are contained in Table 1.
The supervised therapeutic exercise will last approximately 25 min, which will be conducted in 3 progressive stages, 2 weeks each stage. Exercises used in previous studies have been selected such as scapulohumeral stabilization exercises [26, 29, 36], anterior [26] and posterior [37] flexibilization of the joint capsule, Codman exercises [26], proprioception, active and self-paced shoulder exercises [26], full-can exercise [26, 38], strengthening of the rotator cuff and scapular muscles [26, 39, 40]. The deion and dosage of the exercises are set out in Table 2.
Therapeutic exercises at home will last 15 to 20 min or so. Exercises will perform twice per week (alternate days) and for which the physiotherapist will provide the guidelines and training in the treatment sessions.
The exercises will comprise 3 progressive stages as mentioned above, following an information sheet with the relevant instructions for each exercise. In each treatment session participants will be asked about the exercises performed at home, to learn about any difficulties encountered and make the necessary corrections. Participants will be instructed to continue performing therapeutic exercises at home once the intervention is completed and until the last evaluation (at 6 months post-treatment).
Participants will not receive any physiotherapy or medical treatment for shoulder pain during the study intervention. Should any adverse event occur during the execution of the dry needling, or at any time during the ntervention in the study, participants will discontinue participation.
Evaluations
During the baseline measurement, the following deive characteristics will be collected: (i) gender, (II) age, (III) weight, (IV) height (V) dominant hand, (VI) current occupation, (VII) sport. In addition, the following information concerning the affected shoulder will be collected: (I) painful side, (II) duration of pain, (III) prior illness, (IV) taking medication. The chronology of the evaluation of the primary and secondary outcome measures is shown in Table 3.
Primary outcome measures
The main result of this study will be the intensity of shoulder pain measured by Visual Analogue Scale (VAS) for pain. Participants will mark the intensity of their pain on the VAS, consisting of a 100-mm long horizontal line, which is anchored by the classifications of “no pain” at the left end (score 0) and “worst pain imaginable” rightmost (score 10), asking to the participant for the most intense pain episode perceived meanwhile doing daily activity. The VAS has demonstrated the ability to detect changes in pain, establishing a minimal clinically significant difference at 13 mm [41, 42]. And in patients treated for rotator cuff disease a difference at 14 mm [43].
Secondary outcome measures
1. Disabilities of Arm, Shoulder and Hand (DASHe), Spanish version. It will be used to determine the disability rate related to shoulder pain. The DASHe is a self-administered questionnaire consisting of a central body of 30 items and 2 optional modules, each with 4 items, intended to measure the impact of injury of the upper limb by playing musical instruments and performing sport or work. Each item is scored 1 to 5, with increasing values depending on the severity of symptoms. The score of the items are summed to obtain a total score, which can range from 30 to 150 points, which is converted to a scale from 0 (best possible score) to 100 (worst possible score).
Optional modules, if any, are scored separately by the same method. The limit to invalidate the DASHe questionnaire is 4 or more unanswered questions. DASHe questionnaire allows assessing the perceived disability for the patient to perform various activities, including activities of daily life and symptoms such as pain, stiffness and loss of strength [44]. The minimally significant clinical difference in the DASHe for musculoskeletal upper limb problems in adults is 10.2 [45].
2.Pressure Pain Threshold (PPT).Performed with a pressure algometer (Baseline? 30 kg) on the point of greatest mechanical hyperalgesia of the patient’s shoulder, on the spinous process of C7 and on the area of greatest mechanical hyperalgesia of the tibialis anterior. PPT is defined as the amount of pressure applied on the point to be assessed until a painful sensation appears. Three measurements will be carried out and the average will be calculated, to be used for data analysis. 30 s rest will be left between measurements. C7 and tibialis anterior measurements will be used to determine the effect of the central modulation of shoulder pain [28, 46].
It has been established that algometry is a highly reliable technique for PPT measurements when the examiners are well trained. Chesterton et al. [47] showed that changes of more than 17.39 N/cm2 (1.77 kg/cm2) can be considered with certainty to represent real change. Algometry has been used to measure the impact of manual therapy on the treatment of trigger points in cases of shoulder pain with a one month follow-up [28].
3. Shoulder range of motion.It will be measured with a standard 18 cm plastic goniometer (Sammons Preston-Rolyan?). The following shoulder movements will be measured: flexion, extension, internal rotation, external rotation and abduction to end range without pain. Each movement will be measured three times, of which the average will be calculated, to be used in the analysis.
The universal goniometer has shown good intraobserver reliability (intraclass correlation coefficient from 0.91 to 0.99), if consistent benchmarks are used [34], for flexion, extension, abduction and rotation [48]. A change of 6° to 11°is needed to be certain that there has been a real change in the goniometric measurements of the shoulder [34].
Flexion will be measured with the participant in a sitting position with a strap around the abdomen and the back of the chair to limit trunk compensation. The goniometer axis will be aligned with the centre of the joint axis (inferior and lateral to the acromion). The fixed arm of the goniometer will follow the line of the trunk, and the mobile arm, parallel to the longitudinal axis of the humerus and it proceeds to actively raise the arm i with the thumb pointing upwards [34].
For the extension movement, the participant
with the shoulder in the neutral position, elbow flexed 90°and the forearm in the neutral position. The goniometer axis will be placed at the midpoint of the lateral aspect of the glenohumeral joint. The fixed arm will be placed parallel to the patient’s trunk, and the mobile arm, parallel to the longitudinal axis of the humerus. And finally the arm will be actively extended in the sagittal plane [34].
For the abduction movement, the participant will be placed in a sitting position with a strap around the abdomen and the back of the chair to limit trunk compensation. The goniometer axis will be located at the midpoint of the posterior side of the glenohumeral joint. The fixed arm will be placed parallel to the trunk, and the mobile arm, parallel to the longitudinal axis of the humerus. And finally the arm will be actively abducted in the frontal plane, with the thumb pointing upwards to allow the necessary external rotation [34].
As for the internal rotation movement, it will be performed with t 90° shoulder abduction, 90° elbow flexion and forearm in the neutral position. To avoid compensation, the thumb will be placed on the coracoid exerting pressure and the other fingers on the spine of the scapula, to control scapular rise. The goniometer axis will be aligned with the elbow olecranon. The fixed arm will stand upright, vertical to the floor and the mobile arm of the goniometer will be aligned along the midline of the forearm. Finally performing internal rotation [34].
External rotation will be performed with th hips and knees bent at 45°, 90° shoulder abduction, 90° elbow flexion and forearm in neutral. The goniometer axis will be aligned with the elbow olecranon. The fixed arm vertical to the floor and the mobile arm of the goniometer aligned along the midline of the forearm, finally performing
external rotation [34].
4. Strength in shoulder movements.It will be measured with a hand dynamometer (microFET2? Hoggan Scientific LLC). The measurements will be taken in pounds and converted to kilograms-force. Strength in the following movements will be measured: flexion, abduction, external rotation and internal rotation.
For measurements of isometric force in ER (external rotation) and IR (internal rotation), it has been found that the intraclass correlation coefficient (ICC) is 0.93 to 0.99. The minimum detectable change varies from 7.87 N (External Rotation) to 22.11 N (Internal Rotation) [48].
The physiotherapist should stabilize manually or with straps the upper arm, shoulder, scapula and trunk, while performing the tests. Measuring the strength in flexion will be conducted with the participant in a sitting position with the shoulder at 45° of flexion an the Dynamometer will be placed above the lateral epicondyle. The trunk will be strapped to avoid compensation [49]. Abduction will be carried out with the participant in a sitting position with 90° shoulder abduction, 90° elbow flexion and forearm neutral, positioning the dynamometer just proximal to the lateral epicondyle [50].
Measurement of the internal rotation will be carried out with th shoulder abduction, 90° elbow flexion and forearm neutral. The dynamometer will rest on the ventral side of the forearm, 2 cm proximal to the styloid process [48]. For the measurement of external rotation, th 90° shoulder abduction, 90° elbow flexion and forearm neutral. The dynamometer will rest on the back of the forearm, 2 cm proximal to the styloid process [48].
While performing the baseline measurement, data for secondary outcome measures of the participant’s healthy side will also be collected in order to establish whether there is a baseline difference between the two sides before starting the intervention.
Physiotherapist training
For the assessment and treatment, a series of training stages prior to starting the study will be implemented, intended to protocolize the actions carried out in the study. In these training stages, treatment techniques and measuring will be practiced in order to reach a consensus among the physiotherapists involved. Moreover, an external observer will value similarities of interventions between physiotherapists.
Statistical analysis
Data analysis will be carried out following the evaluation standards of the design of experimental studies with a control group. The experimental group (dry needling + manual physiotherapy and therapeutic exercise) will be compared with the control group (sham dry needling + manual physiotherapy and therapeutic exercise).
Data will be analysed using SPSS v.22 software for Windows. All statistical tests will be carried out considering a confidence interval of 95% (p-value &0.05) to determine the effectiveness of the 2 interventions by the method of intention to treat. Prior to statistical comparisons, all data will be analysed to determine the distribution of normality by the Shapiro-Wilk test. Subsequently, the homogeneity of the two intervention groups will be studied using Student’s t test for independent samples for data conforming to normal and the Mann-Whitney test for data that do not. The sex variable will be studied through Pearson χ2 or Fisher’s exact test, if the former cannot be used. Then a deive analysis of the data for the dependent variables will be performed. In these analyses, the mean and standard deviation (SD) for the dependent variables with normal distribution will be calculated. For variables that do not conform to normal, the data will be expressed with the median and first and third quartiles.
For the sex variable, frequencies are used. The existence of differences within each group will be determined, taking into account each group in isolation, between the different measurements (baseline and one wee and post-treatment: at one week, at one month, at 3 months and at 6 months) in each of the study variables. In the VAS variable, measurements will also be taken in th 2nd week, 3rd week, 4thweek, 5th week, 6th week, using ANOVA for repeated measures, supplemented with simple and Helmert-type contrasts for variables that follow normal or Friedman’s ANOVA test, supplemented by Dunn’s multiple comparison test for those variables that will not conform to normal. ANCOVA will be performed to see the effect through different analyzes of the results and to intensify statistical power of the study. For this, the existence of a linear relationship and the homogeneity between the crude and basal scores of the dependent variables will be previously studied.
For comparison between groups, a variable that we define as “difference” for each dependent variable, by subtracting the baseline measurement - at oneweek following needling, baseline - post 1 week, baseline -post 1 month, baseline - post 3 months and baseline - post 6 months (for the DASHe variable, the measurement will not be collected at one week after needling).
For the VAS variable, the “difference” variables will be found between baseline - week 2, week 3, week 4, week 5, week 6. To determine differences in dependent variables between the two intervention groups, the Student t test will be applied for related samples in variables whose data follow normal, in this case the effect size will be calculated according to the formula d = 2 t/√g. In the case of variables whose data do not follow normal, an analysis by the Mann-Whitney test will be performed and the effect size will be estimated according to Grissom procedures according to the formula.
Discussion
This protocol will be carried out for a randomized single-blind clinical trial, in order to investigate whether the inclusion of dry needling in a manual physiotherapy and therapeutic exercise programme has a greater effect in reducing pain and disability in subjects with chronic shoulder pain of unspecific origin.
Chronic shoulder pain is a complex painful condition, with no clear clinical definition [3], whose high recurrence and persistence of symptoms [1, 2], make it difficult to choose the most appropriate treatment. Also a relationship has been shown between high prevalence of myofascial trigger points in the shoulder muscles and the presence of pain [1, 3, 13, 14], so these patients could benefit from an approach focused on muscle treatment.
Moreover, previous studies have shown the efficacy of the combination of manual therapy techniques and therapeutic exercise for shoulder pain, although the best frequency and dosing are not clear [5, 17]. The use of dry needling is recommended in patients with Myofascial Pain Syndrome of the Upper Quadrant [4], while the benefits of a single session of dry needling in a multimodal programme has been observed in cases of post-surgical shoulder pain [19].
Moreover, the benefits of therapeutic exercises in cases of shoulder pain [26, 36], show the importance of including them in the implementation of this protocol, not only during treatment sessions but also at home. Among the exercises included in this protocol, scapular training is a fundamental aspect, as a reduction in electromyographic activation in the serratus anterior and lower trapezius has been observed in patients with shoulder pain, as well as greater activation of the upper trapezius, reflected in a scapulohumeral muscle imbalance [36].
Thus, and based on the literature, we selected different techniques of manual physiotherapy and therapeutic exercise for the creation of this intervention protocol, which also includes a single session of dry needling or sham dry needling to study its potential benefits. Being techniques with few adverse effects and being cheaper in terms of cost-effectiveness, it may be an alternative to more aggressive interventions such as surgery and infiltrations for which similar short-term results have been obtained [51].
Therefore, due to the lack of similar studies for patients with chronic shoulder pain of unspecified origin, the implementation of this study and publication of the results will make a new contribution in the field of chronic shoulder pain treatment, and may establish new research lines in which the effects of dry needling in chronic shoulder pain can be studied and the best frequency and dosage can be established.
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