OsteoarthritisNCT05041231
Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis
A study testing Photobiomodulation therapy (PBT) in people with Osteoarthritis and Osteoarthritis Finger, run by Vita Care at 1 site in Brazil.
Trial summary
Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis Finger, Osteoarthritis Hand
- What is being tested?
- Photobiomodulation therapy (PBT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Aug 2021to 20 Jan 2023
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological diagnosis of OA of the fingers of the hand and Rizarthrosis
- Patients with pain for at least 3 months
- Patients undergoing treatment and rehabilitation for finger OA and rhizarthrosis
- Patient with good understanding of the Portuguese language who agrees to participate and sign the ICF
Who cannot join
- Posttraumatic arthritic changes
- Systemic inflammatory arthritis (Rheumatoid Arthritis, Lupus Erythematosus, Psoriasis…)
- Patients with local or systemic, acute or chronic infections
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed with the aim of both interrupting the natural evolution of the disease and alleviating or stopping the symptoms. This study aims to evaluate the effectiveness of personalized Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the quality of life of these patients with the disease.
- Being tested
- Photobiomodulation therapy (PBT), Sham Photobiomodulation therapy (Sham PBT)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapy (PBT)Device
Also called Laser
Any invasive procedures will be done. The treatment in question will be done by a device that looks like a bracelet, which is placed on the hand/fingers to emit light/laser and does not cause pain or temperature change. There will be 8 photobiomodulation sessions, 2 per week, 10 minutes each session.
The dosimetric parameters of the therapy will be carried out in a standardized and personalized way, with programming of the light and all the necessary information so that the device can carry out the application of the treatment application of electromagnetic waves in the red and infrared spectral range 660-1000 nm).
Sham Photobiomodulation therapy (Sham PBT)Device
Also called Sham Laser
Similar to active PBT, however, the device will not provide the active electromagnetic waves)
| Study group | Role | What they receive |
|---|---|---|
| Sham (group A) | Sham comparator | Treatment procedure performed with the device that will not provide the bioactive light (laser) Receives: Device: Sham Photobiomodulation therapy (Sham PBT) |
| PBT (group B) | Experimental | Treatment procedure performed with the device that will provide the bioactive light (laser) Receives: Device: Photobiomodulation therapy (PBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain at
Visual analogue scale for pain
Measured: 4 weeks and 2 months
Change from Baseline Arm, Shoulder and Hand Disability
The Disabilities of the Arm, Shoulder and Hand Score
Measured: 4 weeks and 2 months
Secondary outcomes (4)
Change from Baseline Hand grip
Hand grip strenght measured by Digital Hand Dynamometer
Measured: 4 weeks and 2 months
Change from Baseline Pinch force
Pulp to pulp (pinch) force
Measured: 4 weeks and 2 months
Willingness to recommend the treatment
Net Promoter Score
Measured: 4 weeks and 2 months
Change from Baseline Hand Disability
Brief Michigan questionnaire
Measured: 4 weeks and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start25 Aug 2021
- Primary completion31 Dec 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vita Care
- Sponsor type
- University, hospital or other
- Collaborators
- Tegos S.A.
- Responsible party
- Sponsor
- Investigators
- Mateus Saito, PhD, Principal investigator, Medical Director Instituto Vita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041231
- Sponsor's protocol ID
- 133
- Status last verified
- Jan 2023
- First submitted
- 25 Aug 2021
- Last updated
- 23 Jan 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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis
- ClinicalTrials.gov ID
- NCT05041231
- Acronym / sponsor ID
- 133
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Vita CareUniversity, hospital or other
- Collaborators
- Tegos S.A.
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 10 Sep 2021 (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.
Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed with the aim of both interrupting the natural evolution of the disease and alleviating or stopping the symptoms. This study aims to evaluate the effectiveness of personalized Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the quality of life of these patients with the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham (group A) | Sham comparator | Device: Sham Photobiomodulation therapy (Sham PBT)Treatment procedure performed with the device that will not provide the bioactive light (laser) |
| PBT (group B) | Experimental | Device: Photobiomodulation therapy (PBT)Treatment procedure performed with the device that will provide the bioactive light (laser) |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and radiological diagnosis of OA of the fingers of the hand and Rizarthrosis
- Patients with pain for at least 3 months
- Patients undergoing treatment and rehabilitation for finger OA and rhizarthrosis
- Patient with good understanding of the Portuguese language who agrees to participate and sign the ICF
Key exclusion criteria (3 listed)
- Posttraumatic arthritic changes
- Systemic inflammatory arthritis (Rheumatoid Arthritis, Lupus Erythematosus, Psoriasis…)
- Patients with local or systemic, acute or chronic infections
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 |
|---|---|---|
| Photobiomodulation therapy (PBT)Also: LaserAny invasive procedures will be done. The treatment in question will be done by a device that looks like a bracelet, which is placed on the hand/fingers to emit light/laser and does not cause pain or temperature change. There will be 8 photobiomodulation sessions, 2 per week, 10 minutes each session. The dosimetric parameters of the therapy will be carried out in a standardized and personalized way, with programming of the light and all the necessary information so that the device can carry out the application of the treatment application of electromagnetic waves in the red and infrared spectral range 660-1000 nm). | Device | PBT (group B) |
| Sham Photobiomodulation therapy (Sham PBT)Also: Sham LaserSimilar to active PBT, however, the device will not provide the active electromagnetic waves) | Device | Sham (group A) |
Primary outcome
Change from Baseline Pain at
Time frame: 4 weeks and 2 months
Visual analogue scale for pain
Change from Baseline Arm, Shoulder and Hand Disability
Time frame: 4 weeks and 2 months
The Disabilities of the Arm, Shoulder and Hand Score
4 secondary outcomes
Change from Baseline Hand grip
Time frame: 4 weeks and 2 months
Change from Baseline Pinch force
Time frame: 4 weeks and 2 months
Willingness to recommend the treatment
Time frame: 4 weeks and 2 months
Change from Baseline Hand Disability
Time frame: 4 weeks and 2 months
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 23 Jan 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.
Mateus Saito, PhD principal investigator
Medical Director Instituto Vita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (PBT) in people with Osteoarthritis and Osteoarthritis Finger, run by Vita Care at 1 site in Brazil.
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 4 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 23 Jan 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 Brazil. 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 from Baseline Pain at (time frame: 4 weeks and 2 months). The study lists 2 primary outcomes in all. 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 23 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.