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This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HILT group | Experimental | High-intensity laser therapy application through HIRO 3.0 device |
|
| Placebo group | Sham Comparator | Sham high-intensity laser therapy application through HIRO 3.0 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIRO® 3.0 | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justyna Wyszyńska, PhD | University of Rzeszow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rzeszów | Rzeszów | 35-205 | Poland |
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| Sham laser | Device | 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. |
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| 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 |