An interventional study of HIRO® 3.0 and Sham laser in Osteoarthritis of the Shoulder, sponsored by University of Rzeszow. Completed at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by University of Rzeszow · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
High-intensity laser therapy application through HIRO 3.0 device
Device: HIRO® 3.0
Sham high-intensity laser therapy application through HIRO 3.0 device
Device: Sham laser
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).
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.
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
Time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Rzeszow