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Motor Control Training in Individuals With Subacromial Pain Syndrome

2021年4月29日 更新者:Jamilson Simões Brasileiro、Universidade Federal do Rio Grande do Norte

Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial

The porpusose of this study is to evaluate the repercussions of a motor control exercise protocol in patients with subacromial pain syndrome without indication of surgical repair.

研究概览

详细说明

Methods: This is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers will be randomly divided into two groups to carry out the intervention: exercises (GE - conventional exercises with elastic band) and motor control (GCM - motor control training). The intervention protocol will last eight weeks. After four weeks, the second assessment (AV2), similar to AV1, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (AV3), similar to AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to AV3.

The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov. The study will only begin after approval of the ethics and research committee. All volunteers should read and sign the terms of free and informed consent.

研究类型

介入性

注册 (实际的)

34

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

    • RN
      • Natal、RN、巴西、59140-840
        • Jamilson S Brasileiro
      • Parnamirim、RN、巴西、59152820
        • Karinna Sonálya Aires da Costa

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

35年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Present subacromial pain with a score greater than or equal to 2 (Visual Analog Scale) for more than 2 months;
  • Positive Neer test;
  • Positive Hawkins test;
  • Positive Jobe test (pain);
  • Positive Patte test (pain);
  • Involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by Magnetic Nuclear Resonance (MRI) examination.

Exclusion Criteria:

  • Intense pain during the evaluations;
  • Fail to properly perform the evaluation procedures;
  • Two consecutive or five alternating absences during the training protocol.

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:motor control training
8-week exercise program, twice a week, with motor control training
The volunteers of the motor control group will initiate the exercises on a stable and rigid basis. These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol). For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.
有源比较器:exercises
8-week exercise program, twice a week.
the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.

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
Shoulder pain
大体时间:Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Evaluation of pain level in the shoulder using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.
Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
肩部功能
大体时间:干预方案后 4 周、8 周和 4 周随访时肩功能相对于基线的变化
使用手臂、肩部和手部残疾 (DASH) 评估肩部疼痛和功能。 该问卷是一种自我管理的特定区域结果工具,用于衡量自评上肢残疾和症状。 DASH 主要由 30 项残疾/症状量表组成,评分为 0(无残疾)至 100。 分数越高,功能障碍越严重。
干预方案后 4 周、8 周和 4 周随访时肩功能相对于基线的变化

次要结果测量

结果测量
措施说明
大体时间
Root Mean Square (RMS)
大体时间:Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Analyze of the electromyographic activity of the muscles shoulder complex, after 4 and 8 weeks of the protocol and a follow up of 4 weeks after the intervention protocol, by Root Mean Square (RMS)
Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
The kinematics of the scapula
大体时间:Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Analyze the kinematics of the scapula and glenohumeral in the slow and habitual movements after 8 weeks of the protocol and a follow up of 4 weeks.
Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Peak of muscular torque
大体时间:Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Peak torque time
大体时间:Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Range of motion
大体时间:Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Measure the range of motion for flexion, hyperextension, internal and external shoulder rotation 8 weeks of protocol and a follow up of 4 weeks, through the inclinometer.
Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

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。

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)

2019年6月17日

初级完成 (实际的)

2020年1月30日

研究完成 (实际的)

2020年1月30日

研究注册日期

首次提交

2019年6月28日

首先提交符合 QC 标准的

2019年9月24日

首次发布 (实际的)

2019年9月26日

研究记录更新

最后更新发布 (实际的)

2021年4月30日

上次提交的符合 QC 标准的更新

2021年4月29日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • KSACO2019

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

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