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

Primary Purpose

Rotator Cuff Injury, Diaphragm; Relaxation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diaphragm manual therapy techniques
Diaphragm mobilization through active hipopressive gymnastic exercise
Ischemic compression techniques in shoulder myofascial trigger points
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injury focused on measuring rotator cuff injury, diaphragm, physical therapy, manual therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Diaphragm manual therapy

Diaphragm hipopressive exercise

Shoulder myofascial trigger points treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2017
Last Updated
March 9, 2020
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03293329
Brief Title
Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
Official Title
Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury, Diaphragm; Relaxation
Keywords
rotator cuff injury, diaphragm, physical therapy, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragm manual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Diaphragm hipopressive exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Shoulder myofascial trigger points treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragm manual therapy techniques
Intervention Description
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
Intervention Name(s)
Diaphragm mobilization through active hipopressive gymnastic exercise
Intervention Description
Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.
Intervention Type
Other
Intervention Name(s)
Ischemic compression techniques in shoulder myofascial trigger points
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline to post intervention shoulder range of motion with a digital inclinometer
Description
Pre and post treatment assessment of flexion, abduction and external rotation at 90º abduction movements in supine, registered with a Baseline digital inclinometer
Time Frame
Baseline and Immediately Post Intervention
Title
Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer
Description
Pre and post treatment Pressure pain threshold in supraespinatus tendon and xiphoid process registered with a pressure algometer in a supine position
Time Frame
Baseline and Immediately Post Intervention
Title
Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility
Description
Pre and post treatment Numerical Rating Pain Scale in shoulder mobility: flexion, abduction and external rotation at 90º abduction standing
Time Frame
Baseline and Immediately Post Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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