Rotator Cuff InjuryNCT03293329
Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
A study testing Diaphragm manual therapy techniques, Diaphragm mobilization through active hipopressive gymnastic exercise and Ischemic compression techniques in shoulder myofascial trigger points in people with Rotator Cuff Injury and Diaphragm; Relaxation, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injury, Diaphragm; Relaxation
- What is being tested?
- Diaphragm manual therapy techniques, Diaphragm mobilization through active hipopressive gymnastic exercise and Ischemic compression techniques in shoulder myofascial trigger points
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2020to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Injury, Diaphragm; Relaxation
- Being tested
- Diaphragm manual therapy techniques, Diaphragm mobilization through active hipopressive gymnastic exercise, Ischemic compression techniques in shoulder myofascial trigger points
- Keywords
- rotator cuff injury, diaphragm, physical therapy, manual therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm manual therapy techniquesOther
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 exerciseOther
Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.
Ischemic compression techniques in shoulder myofascial trigger pointsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Ischemic compression techniques in shoulder myofascial trigger points |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline and Immediately Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start9 Mar 2020
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidro Fernández López, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293329
- Sponsor's protocol ID
- UComplutenseMadrid Fasisifer1
- Other IDs
- 2017-003316-39, 2017
- Status last verified
- Mar 2020
- First submitted
- 16 Sep 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
- ClinicalTrials.gov ID
- NCT03293329
- Acronym / sponsor ID
- UComplutenseMadrid Fasisifer1
- Conditions
- Rotator Cuff Injury, Diaphragm; Relaxation
- Keywords
- rotator cuff injury, diaphragm, physical therapy, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diaphragm manual therapy | Experimental | Other: Diaphragm manual therapy techniques3 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 hipopressive exercise | Experimental | Other: Diaphragm mobilization through active hipopressive gymnastic exerciseDiaphragm 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. |
| Shoulder myofascial trigger points treatment | Active comparator | Other: Ischemic compression techniques in shoulder myofascial trigger pointsA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm manual therapy techniques3 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. | Other | Diaphragm manual therapy |
| Diaphragm mobilization through active hipopressive gymnastic exerciseDiaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward. | Other | Diaphragm hipopressive exercise |
| Ischemic compression techniques in shoulder myofascial trigger pointsIschemic 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. | Other | Shoulder myofascial trigger points treatment |
Primary outcome
Change from baseline to post intervention shoulder range of motion with a digital inclinometer
Time frame: Baseline and Immediately Post Intervention
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
Time frame: Baseline and Immediately Post Intervention
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
Time frame: Baseline and Immediately Post Intervention
Pre and post treatment Numerical Rating Pain Scale in shoulder mobility: flexion, abduction and external rotation at 90º abduction standing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm manual therapy techniques, Diaphragm mobilization through active hipopressive gymnastic exercise and Ischemic compression techniques in shoulder myofascial trigger points in people with Rotator Cuff Injury and Diaphragm; Relaxation, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to post intervention shoulder range of motion with a digital inclinometer (time frame: Baseline and Immediately Post Intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.