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

Rotator Cuff Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293329
• Other study ID #: UComplutenseMadrid Fasisifer1
• Secondary ID: 2017-003316-39
• Status: Completed
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: March 9, 2020

Study information

• Verified date: March 2020
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. - 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.

2. - Experimental group 2: diaphragm mobilization through active hipopressive gymnastic exercise according to Caufriez in two different postures.

3. - 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm; Relaxation
• Rotator Cuff Injuries
• Rotator Cuff Injury
• Wounds and Injuries

Intervention

Other:
• Diaphragm manual therapy techniques
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
Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.
• Ischemic compression techniques in shoulder myofascial trigger points
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.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to post intervention shoulder range of motion with a digital inclinometer	Pre and post treatment assessment of flexion, abduction and external rotation at 90º abduction movements in supine, registered with a Baseline digital inclinometer	Baseline and Immediately Post Intervention
Primary	Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer	Pre and post treatment Pressure pain threshold in supraespinatus tendon and xiphoid process registered with a pressure algometer in a supine position	Baseline and Immediately Post Intervention
Primary	Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility	Pre and post treatment Numerical Rating Pain Scale in shoulder mobility: flexion, abduction and external rotation at 90º abduction standing	Baseline and Immediately Post Intervention