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临床试验/NCT03293329
NCT03293329已完成不适用

Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer

研究概览

简要总结

A randomised and controlled trial to people diagnosed with rotator cuff injuries who are divided into 3 groups of treatment: shoulder myofascial trigger points release, manual diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. The pain and range of shoulder movement are assessed before and after the treatment in all the participants.

Hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or active mobilization, has impact on rotator cuff injury symptoms comparing with a standard treatment of shoulder myofascial trigger points release.

Discussion: The relation between shoulder and diaphragm muscle, through innervation (phrenic nerve and brachial plexus), embryology and myofascial connections, could lead to include in clinical practice the examination and treatment of other structures besides shoulder girdle such as diaphragmatic region in rotator cuff injuries.

详细描述

This study is a randomised controlled trial evaluating clinical effects of a diaphragm treatment, via manual release or active mobilization, comparing with a standard treatment of shoulder myofascial trigger points release.

A description of the 3 groups of treatment:

    • Experimental group 1: 3 diaphragm stretching techniques according to Chaitow, Ward and Ricard, performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position.
    • Experimental group 2: diaphragm mobilization through active hipopressive gymnastic exercise according to Caufriez in two different postures.
    • Active comparator group: A ischemic compression technique in most painful myofascial trigger points in the infraespinatus and supraespinatus muscle during one minute each one.

The shoulder flexion, abduction and external rotation range of motion will be assessed pre and postinterventions, as well as the pressure pain threshold with an algometer and the pain experienced by the individual in shoulder mobility with a Numerical Rating Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of both genders aged between 18 and 65 years old
  • Ultrasound and/or magnetic resonance imaging diagnosis of rotator cuff injury
  • Pain or range of movement restriction in active shoulder flexion and/or abduction

排除标准

  • Use of analgesic or anti-inflammatory drugs 72 hours prior to the study
  • Individuals with glenohumeral instability due to shoulder luxation or subluxation or Bankart labrum injury
  • Individuals who have received physical therapy treatment in last week
  • Individuals who underwent thoracic or shoulder surgery or people suffering from rheumatisms
  • Diabetic patients
  • People with a diagnosed neurological pathology
  • Individuals with a diagnosed mental health problem
  • Not being able to understand and sign the informed consent and information sheet

结局指标

主要结局

Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer

时间窗: Baseline and Immediately Post Intervention

Pre and post treatment Pressure pain threshold in supraespinatus tendon and xiphoid process registered with a pressure algometer in a supine position

Change from baseline to post intervention shoulder range of motion with a digital inclinometer

时间窗: Baseline and Immediately Post Intervention

Pre and post treatment assessment of flexion, abduction and external rotation at 90º abduction movements in supine, registered with a Baseline digital inclinometer

Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility

时间窗: Baseline and Immediately Post Intervention

Pre and post treatment Numerical Rating Pain Scale in shoulder mobility: flexion, abduction and external rotation at 90º abduction standing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isidro Fernández López

Principal Investigator

Universidad Complutense de Madrid

研究点 (1)

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