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

NCT ID: NCT03293329

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2020-03-09

Brief 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.

Detailed 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.

Conditions

Rotator Cuff Injury; Diaphragm; Relaxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diaphragm manual therapy

3 diaphragm stretching 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. 20 people are recruited in order to the inclusion criteria for the study. They have rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.

Group Type: EXPERIMENTAL

Diaphragm manual therapy techniques

Intervention Type: 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 hipopressive exercise

Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures. 20 people are recruited in order to the inclusion criteria for the study. They have rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.

Group Type: EXPERIMENTAL

Diaphragm mobilization through active hipopressive gymnastic exercise

Intervention Type: OTHER

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

Shoulder myofascial trigger points treatment

A ischemic compression technique in infraespinatus and supraespinatus myofascial trigger points performed by a physical therapist is employed in this group. 20 people are recruited in order to the inclusion criteria for the study. They had rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.

Group Type: ACTIVE_COMPARATOR

Ischemic compression techniques in shoulder myofascial trigger points

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Diaphragm mobilization through active hipopressive gymnastic exercise

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Isidro Fernández López

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003316-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UComplutenseMadrid Fasisifer1

Identifier Type: -

Identifier Source: org_study_id