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振动疗法与IASTM在肩峰下撞击综合征中的应用

2026年7月23日 更新者:Emre DANSUK

振动疗法和器械辅助软组织松动术对肩峰下撞击综合征患者疼痛、活动范围、功能、关节位置觉和生活质量的影响

这项随机对照临床研究旨在探讨在传统物理治疗基础上增加振动疗法和器械辅助软组织松动术(IASTM)对诊断为肩峰下撞击综合征(SAIS)患者的疼痛、关节活动度、本体感觉、功能状态和生活质量的影响。 SAIS是肩痛最常见的原因之一,常与肩胛骨运动学异常、肩袖功能障碍、软组织紧张和肩关节活动度下降相关。

研究将招募48名年龄40-60岁、经MRI确诊的SAIS参与者,随机分为三组:(1) 振动疗法+传统物理治疗,(2) IASTM+传统物理治疗,(3) 传统物理治疗(对照组)。 所有干预措施将每周进行三次,持续四周。 评估指标包括疼痛强度(视觉模拟评分法)、肩关节活动度(角度测量仪Pro应用)、屈曲和外展60°时的本体感觉、功能状态(手臂、肩部和手部残疾问卷)和生活质量(肩袖生活质量问卷)。

本研究旨在确定在标准物理治疗基础上增加振动疗法或IASTM是否能为肩峰下撞击综合征患者带来减轻疼痛、改善关节活动度、增强本体感觉敏锐度和提高功能能力的额外短期益处。

研究概览

详细说明

肩峰下撞击综合征(SAIS)是最常见的肌肉骨骼疾病之一,影响约20-30%的普通人群,是肩痛的主要原因。 SAIS与肩胛骨运动学改变、肩袖肌群失衡、软组织紧张、姿势异常和神经肌肉控制受损有关。 传统物理治疗——包括治疗性锻炼、拉伸、电疗方式和手法技术——在临床实践中被广泛应用。 然而,证据表明,将手法或软组织干预与标准物理治疗相结合,可能在疼痛、活动度和肩关节功能方面带来更有效的改善。

器械辅助软组织松动术(IASTM)是一种手法治疗技术,使用符合人体工程学设计的不锈钢工具对软组织提供受控的机械刺激。 IASTM最近因其能够增加软组织延展性、促进肌筋膜释放和增强关节活动范围而受到关注。 同样,基于振动的干预——包括冲击按摩疗法——已被证明通过机械振荡和感觉受体的刺激来改善循环、减轻疼痛、减少肌肉僵硬并增强活动度。 尽管它们越来越受欢迎,但关于振动疗法和IASTM在SAIS患者中的直接比较的证据有限。

这项随机对照试验旨在评估在传统物理治疗基础上增加振动疗法或IASTM是否比单独使用传统物理治疗提供更优的结果。 总共48名年龄在40-60岁之间、经MRI确诊为SAIS的成年人将被随机分配到三组:(1)振动疗法+传统物理治疗,(2)IASTM+传统物理治疗,和(3)传统物理治疗(对照组)。 所有干预措施将每周进行三次,持续四周。 振动疗法将使用冲击按摩设备(33赫兹)沿起止点路径应用于三角肌和肩袖肌群。 IASTM将使用标准化的扫刷技术以45度角应用于肩部前侧和后侧肌群。 对照组将接受由物理治疗师监督的传统物理治疗,包括超声波、经皮神经电刺激、冷冻疗法、被动拉伸、Codman练习、棒操、手指爬梯练习和渐进性强化训练。

结果测量包括疼痛强度(视觉模拟量表)、使用Goniometer Pro移动应用测量的肩关节活动范围、在60度屈曲和外展时评估的本体感觉、使用DASH问卷评估的功能障碍,以及使用RC-QoL量表测量的肩部相关生活质量。 评估将在基线和4周干预期后进行。

本研究旨在通过直接比较SAIS人群中两种常用的软组织干预——振动疗法和IASTM——为当前文献做出贡献。 研究结果有望为临床医生提供信息,了解将这些模式与传统物理治疗相结合的潜在附加益处,以优化肩峰下撞击综合征患者的疼痛减轻、功能改善和神经肌肉结果。

研究类型

介入性

注册 (实际的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

纳入标准:

  • 经MRI确诊为肩峰下撞击综合征的患者
  • 年龄在40至60岁之间的男性和女性
  • 症状持续超过一个月

排除标准:

  • 受影响手臂有手术史
  • 手臂存在开放性伤口
  • 存在感染
  • 炎性关节疾病
  • 肩关节骨关节炎
  • 存在风湿性疾病
  • 恶性或良性肿瘤
  • 无法耐受振动疗法

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Percussion Massage Therapy Plus Conventional Physiotherapy
Participants received the standardized conventional physiotherapy programme for four weeks and additionally received percussion massage therapy three times per week for four weeks.

Percussion massage therapy was administered using a handheld Hypervolt device (Hyperice, California, USA) at 33 Hz, corresponding to level 2 of the device. A flat-head attachment was used to provide uniform contact with the treated tissues.

The intervention was applied to the deltoid, supraspinatus, infraspinatus, and teres minor muscles along their anatomical fibre orientation. Each muscle was treated for three minutes using controlled longitudinal strokes applied alternately in proximal-to-distal and distal-to-proximal directions. The intervention was administered by the same licensed physiotherapist three times per week for four weeks, concurrently with the conventional physiotherapy programme.

其他名称:
  • Hypervolt Percussion Massage Device

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme.

The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

实验性的:IASTM Plus Conventional Physiotherapy
Participants received the standardized conventional physiotherapy programme for four weeks and additionally received instrument-assisted soft tissue mobilization three times per week for four weeks.

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme.

The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

Instrument-assisted soft tissue mobilization was administered to the deltoid, supraspinatus, infraspinatus, and teres minor muscles three times per week for four weeks. All applications were performed by the same licensed physiotherapist.

Standardized sweep and brush stroke techniques were applied at an approximate treatment angle of 45 degrees and in accordance with the anatomical fibre orientation of each muscle. For each muscle, 20 seconds of parallel strokes were followed by 20 seconds of perpendicular strokes using controlled sweeping movements. The intervention was provided in addition to the conventional physiotherapy programme.

其他名称:
  • 国际标准协会
有源比较器:Conventional Physiotherapy
Participants received a standardized, supervised conventional physiotherapy programme five sessions per week for four weeks.

Participants received a standardized, supervised conventional physiotherapy programme for four weeks, administered five sessions per week by a licensed physiotherapist. Each session included transcutaneous electrical nerve stimulation applied to the symptomatic shoulder for 20 minutes at 100 Hz, followed by a structured exercise programme.

The exercise programme included wand-assisted active range-of-motion exercises for shoulder flexion, abduction, extension, internal rotation, and external rotation; Codman pendulum exercises; active and passive stretching; and finger ladder exercises. Progressive strengthening exercises using elastic resistance bands were performed for shoulder flexion, abduction, internal rotation, external rotation, and extension. Resistance was progressively adjusted according to pain severity, functional capacity, and treatment tolerance, while a standardized volume of 10 repetitions per set was maintained.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Shoulder Joint Position Sense Error
大体时间:Baseline and immediately after the 4-week intervention

Shoulder joint position sense was assessed using a digital goniometer at target positions of 60 degrees of shoulder flexion and 60 degrees of shoulder abduction. The affected shoulder was passively positioned at the target angle, and the participant was allowed up to 10 seconds to memorize the position. The arm was then returned to the neutral position, and the participant was asked to actively reproduce the target position with the eyes closed.

The absolute angular difference between the target position and the reproduced position was calculated in degrees. Three trials were conducted for flexion and three trials for abduction, and the mean absolute error for each direction was used in the analysis. Lower values indicate greater joint position sense accuracy.

Baseline and immediately after the 4-week intervention

次要结果测量

结果测量
措施说明
大体时间
Change in Shoulder Range of Motion
大体时间:Baseline and immediately after the 4-week intervention
Active shoulder range of motion was measured in degrees using a digital goniometer under standardized assessment conditions. Shoulder flexion, abduction, internal rotation, and external rotation were assessed. Higher values represent greater shoulder range of motion.
Baseline and immediately after the 4-week intervention
Change in Resting and Activity-Related Shoulder Pain
大体时间:Baseline and immediately after the 4-week intervention
Resting and activity-related shoulder pain intensity were assessed separately using a 10-centimetre Visual Analog Scale. The scale was anchored by 0, indicating no pain, and 10, indicating the worst imaginable pain. Participants marked their pain intensity on the scale, and the distance from the zero anchor was measured in centimetres. Lower scores indicate lower pain intensity.
Baseline and immediately after the 4-week intervention
Change in Upper-Extremity Disability
大体时间:Baseline and immediately after the 4-week intervention
Upper-extremity disability was assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire. The questionnaire contains 30 items and generates a total score ranging from 0 to 100. Higher scores indicate greater upper-extremity disability, whereas lower scores indicate better function.
Baseline and immediately after the 4-week intervention
Change in Rotator Cuff-Related Quality of Life
大体时间:Baseline and immediately after the 4-week intervention
Rotator cuff-related quality of life was assessed using the Rotator Cuff Quality of Life questionnaire. The questionnaire contains 34 items covering physical symptoms, work, daily activities, social functioning, and emotional well-being. Scores are expressed on a scale from 0 to 100, with higher scores indicating better rotator cuff-related quality of life.
Baseline and immediately after the 4-week intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Emre DANSUK, PhD、Medipol University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月10日

初级完成 (实际的)

2026年2月1日

研究完成 (实际的)

2026年2月15日

研究注册日期

首次提交

2025年12月6日

首先提交符合 QC 标准的

2025年12月6日

首次发布 (实际的)

2025年12月18日

研究记录更新

最后更新发布 (实际的)

2026年7月24日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes. Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements.

IPD 共享时间框架

Beginning immediately after publication and available for five years.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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