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| Name | Class |
|---|---|
| Castilla-La Mancha Health Service | OTHER |
| Hospital General Nuestra Señora del Prado | OTHER |
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The purpose of this study is to assess the effectiveness of high intensity laser therapy in the treatment of subacromial impingement syndrome.
Shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain.
Symptoms of pathologies of subacromial space impingement syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life. Because of the need to implement research to assess the effectiveness of high intensity laser therapy with new studies mayor methodological quality of obtaining conclusive results, and based on the scientific evidence supporting the low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we consider very interesting the realization of this research project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity laser therapy | Experimental | High-intensity laser therapy application through iLux Laser device |
|
| Sham device | Sham Comparator | Sham high-intensity laser therapy application through sham iLux Laser device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iLux Laser | Device | Treatment during 15 sessions. It is divided in two phases: 1. 12W. 50 Hz 20% duty cycle. 50 J/cm² in painful zone. 2. 15 W. Burst (10 pulses-900 msec each train) 250 J/cm² in painful zone. Trough the iLux Laser (Mectronic Medicale, Italy) + Physical Therapy protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain and Disability Index (SPADI) | SPADI test | Baseline |
| Shoulder Pain and Disability Index (SPADI) | SPADI test | At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-) |
| Shoulder Pain and Disability Index (SPADI) | SPADI test | one month after the end of the protocol treatment |
| Shoulder Pain and Disability Index (SPADI) | SPADI test | three months after the end of the protocol treatment |
| Constant-Murley Score | Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points. | Baseline |
| Constant-Murley Score | Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points. | At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-) |
| Constant-Murley Score | Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points. | one month after the end of the protocol treatment |
| Constant-Murley Score |
| Measure | Description | Time Frame |
|---|---|---|
| Painful pressure threshold | The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton. | Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment |
| Painful pressure threshold after first session |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | EQ-5D™ is a standardised instrument for use as a measure of health outcome. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Aceituno-Gomez, PT | Castilla-La Mancha Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Nuestra Señora del Prado | Talavera de la Reina | Toledo | 45600 | Spain |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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|
| Sham ilux Laser | Device | Sham treatment during 15 sessions trough the iLux Laser (Mectronic Medicale, Italy), It is applies the same time than experimental one but with 0 W + Physical Therapy protocol. |
|
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points. |
| three months after the end of the protocol treatment |
| Quick-Dash Abbreviated | Quick- Dash Abbreviated test | Baseline |
| Quick-Dash Abbreviated | Quick- Dash Abbreviated test | At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-) |
| Quick-Dash Abbreviated | Quick- Dash Abbreviated test | one month after the end of the protocol treatment |
| Quick-Dash Abbreviated | Quick- Dash Abbreviated test | three months after the end of the protocol treatment |
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton. |
| First session - 15 minutes after laser or sham treatment. |
| VAS | Visual analogue scale | Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment |