Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome

Conditions
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Subacromial Impingement

Intervention / Treatment
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* Device: iLux Laser
* Device: Sham ilux Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 75 years old with diagnosis of subacromial impingement syndrome or any of the pathologies that compose it (tendinosis-tendinitis supraspinatus and rest of the rotator cuff, subacromial bursitis and tendinitis of the long head of the biceps). Visual Analogue Scale (VAS) less than or equal to 7. Forward flexion at least of 100º Exclusion Criteria: Calcific tendinitis Complete rupture of the rotator cuff. Adhesive capsulitis. Clinical history of pathologies that without affecting the shoulder joint refer to painful shoulder symptoms (cervical root involvement, cervical surgery, cervical osteoarthritis and neurological pathologies) Fibromyalgia Be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment. Patients with alterations of thermal sensitivity. Derived from the absolute and relative contraindications of Laser Therapy: Photosensitive patients Neoplastic processes Hyperthyroidism Pregnancy Patients with a history of epileptic seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity laser therapy<br>High-intensity laser therapy application through iLux Laser device | Device: iLux Laser<br>* 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.<br>|
| Sham Comparator: Sham device<br>Sham high-intensity laser therapy application through sham iLux Laser device | Device: Sham ilux Laser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |