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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003316-39 | EudraCT Number |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense de Madrid | Madrid | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2017 | Sep 24, 2017 |
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| Diaphragm mobilization through active hipopressive gymnastic exercise | Other | Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward. |
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| 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. |
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| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2017 | Sep 24, 2017 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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