Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-01-02
2019-08-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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HILT group
High-intensity laser therapy application through HIRO 3.0 device
HIRO® 3.0
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).
Placebo group
Sham high-intensity laser therapy application through HIRO 3.0 device
Sham laser
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.
Interventions
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HIRO® 3.0
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).
Sham laser
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.
Eligibility Criteria
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Inclusion Criteria
2. not engage in any other treatment during treatment period
3. pain ≥4 on the visual analog scale (VAS) in the previous 3 months
Exclusion Criteria
2. receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months
3. absolute and relative contraindications of Laser Therapy
18 Years
75 Years
ALL
No
Sponsors
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University of Rzeszow
OTHER
Responsible Party
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Justyna Wyszyńska
Principal Investigator
Principal Investigators
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Justyna Wyszyńska, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rzeszow
Locations
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University of Rzeszów
Rzeszów, , Poland
Countries
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Other Identifiers
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HILT-osteoarthritis
Identifier Type: -
Identifier Source: org_study_id
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