Effectiveness of HILT in Shoulder Osteoarthritis

Study Overview
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Brief Summary
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This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.

Detailed Description
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Shoulder osteoarthritis (SO) is a musculoskeletal joint disease that affects the elderly. SO is characterized by degeneration of the articular cartilage in the involved joints and its underlying bone within a joint as well as bony overgrowth. It is one of the major causes of physical disability that has a social and public health impact due to pain, stiffness, joint instability, and muscle weakness. The diagnosed patients with SO will be treated with HILT for a total of ten sessions during the entire duration of the treatment protocol. Parameters to be evaluated are: range of motion, pressure pain (algometer), pain perception (Visual Analog Scale (VAS), Modified Laitinen Pain Questionnaire), quality of life (WHOQoL-BREF) These parameters will be recorded before the first treatment (baseline), after completion of treatment, three and 12 months after completion treatment. A change in above parameters will be evaluated.

Official Title
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Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study

Conditions
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Osteoarthritis of the Shoulder

Intervention / Treatment
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* Device: HIRO® 3.0
* Device: Sham laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: painful osteoarthritis of the shoulder for at least 6 months not engage in any other treatment during treatment period pain ≥4 on the visual analog scale (VAS) in the previous 3 months Exclusion Criteria: presence of any other musculoskeletal problems associated with the shoulder joint, such as fracture, tendon or ligament tears, meniscus injury, rheumatoid arthritis, or shoulder surgery receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months absolute and relative contraindications of Laser Therapy

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HILT group<br>High-intensity laser therapy application through HIRO 3.0 device | Device: HIRO® 3.0<br>* Patients will receive pulsed Nd:YAG (yttrium aluminum garnet) laser, produced by HIRO 3.0 device (ASA, Vicenza, Italy). The total energy deliver to the patient during one session will be 3.000 J through three phases of treatment. HILT will be applied for a total of 4 weeks (three sessions/week).<br>|
| Sham Comparator: Placebo group<br>Sham high-intensity laser therapy application through HIRO 3.0 device | Device: Sham laser<br>* For sham laser, the patient will attended the physical therapy clinic three times a week for 4 weeks and receive sham laser. It is applies the same time than experimental one but with 0 W.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the pain perception | Evolution of pain (Visual Analogic Scale and the Modified Laitinen Pain Questionnaire) between baseline, after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment | at baseline, immediately after treatment completion, 3 and 12 months after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the quality of life | Comparison of the WHOQOL-BREF questionnaire mean between baseline, immediately after treatment the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment. Quantitative evaluation of the primary outcome. | at baseline, immediately after treatment completion, 3 and 12 months after treatment completion | 
| Change in the range of motion | Comparison of the range of motion between baseline, immediately after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment. Quantitative evaluation of the primary outcome. | at baseline, immediately after treatment completion, 3 and 12 months after treatment completion | 
| Change in the pressure pain | Comparison of the pressure pain (algometer) between baseline, immediately after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment. Quantitative evaluation of the primary outcome. | at baseline, immediately after treatment completion, 3 and 12 months after treatment completion |