Osteoarthritis of the ShoulderNCT03385408
Effectiveness of HILT in Shoulder Osteoarthritis
A study testing HIRO® 3.0 in people with Osteoarthritis of the Shoulder, run by University of Rzeszow at 1 site in Poland.
Trial summary
This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- HIRO® 3.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2018to 21 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study
This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.
Read the detailed description
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.
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- HIRO® 3.0, Sham laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIRO® 3.0Device
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 laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HILT group | Experimental | High-intensity laser therapy application through HIRO 3.0 device Receives: Device: HIRO® 3.0 |
| Placebo group | Sham comparator | Sham high-intensity laser therapy application through HIRO 3.0 device Receives: Device: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start2 Jan 2018
- Primary completion21 Feb 2018
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Wyszyńska, University of Rzeszow
- Investigators
- Justyna Wyszyńska, PhD, Principal investigator, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385408
- Sponsor's protocol ID
- HILT-osteoarthritis
- Status last verified
- Feb 2023
- First submitted
- 20 Dec 2017
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03385408
- Acronym / sponsor ID
- HILT-osteoarthritis
- Conditions
- Osteoarthritis of the Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT group | Experimental | Device: HIRO® 3.0High-intensity laser therapy application through HIRO 3.0 device |
| Placebo group | Sham comparator | Device: Sham laserSham high-intensity laser therapy application through HIRO 3.0 device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIRO® 3.0Patients 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). | Device | HILT group |
| Sham laserFor 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. | Device | Placebo group |
Primary outcome
Change in the pain perception
Time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
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
3 secondary outcomes
Change in the quality of life
Time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Change in the range of motion
Time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Change in the pressure pain
Time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justyna Wyszyńska, PhD principal investigator
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIRO® 3.0 in people with Osteoarthritis of the Shoulder, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the pain perception (time frame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.