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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injury; Diaphragm; Relaxation
• Intervention / Treatment: Other: Diaphragm manual therapy techniques; Other: Diaphragm mobilization through active hipopressive gymnastic exercise; Other: Ischemic compression techniques in shoulder myofascial trigger points

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
EXPERIMENTAL: 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.	Other: Diaphragm mobilization through active hipopressive gymnastic exercise; Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2020
• Primary Completion (ACTUAL): March 9, 2020
• Study Completion (ACTUAL): March 9, 2020

Study Registration Dates

• First Submitted: September 16, 2017
• First Submitted That Met QC Criteria: September 24, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: manual therapy; physical therapy; rotator cuff injury; diaphragm
• Additional Relevant MeSH Terms: Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Wounds and Injuries
• Other Study ID Numbers: UComplutenseMadrid Fasisifer1; 2017-003316-39 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No