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

NCT03293329 | Completed

• 2 other identifiers: UComplutenseMadrid Fasisifer12017-003316-39
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injury; Diaphragm; Relaxation

Keywords

rotator cuff injury; diaphragm; physical therapy; manual therapy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Diaphragm manual therapy

EXPERIMENTAL

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

Diaphragm hipopressive exercise

EXPERIMENTAL

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

Shoulder myofascial trigger points treatment

ACTIVE COMPARATOR

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

Interventions

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 manual therapy

Diaphragm mobilization through active hipopressive gymnastic exercise OTHER

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

Diaphragm hipopressive exercise

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.

Shoulder myofascial trigger points treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2017
• First Posted: September 26, 2017
• Study Start: March 9, 2020
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

ES (1)