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Completed

NCT Number: NCT03293329

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

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.

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Key information

Conditions

Rotator Cuff Injury Diaphragm; Relaxation Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Diaphragm manual therapy techniques

Other

3 diaphragm manual therapy techniques 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.

Diaphragm mobilization through active hipopressive gymnastic exercise

Other

Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.

Ischemic compression techniques in shoulder myofascial trigger points

Other

Ischemic compression techniques in infraespinatus and supraespinatus myofascial trigger points during one minute each muscle. The pressure increases gradually until the individual feels a tolerable pain.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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