Osteo Arthritis KneeNCT03924128
Study of the Effects of Photobiomodulation in Patients With Osteoarthritis
A study testing Photobiomodulation in people with Osteo Arthritis Knee and Pain, Chronic, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
PhotoBioModulation (PBM) is a mature science with therapeutic efficacy in humans and animals, and with excellent results in different medical specialties without side effects. However there are gaps that prevent adoption on a large scale. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Pain, Chronic, Inflammation
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects age ≥ 20 years old
- Diagnosed with Osteoarthritis stages III and IV according to the American College of Rheumatology
- Pain
- Functional impairment for more than 3 months, able to wander with or without canes.
Who cannot join
- History of cancer
- Unstable cardiovascular disease
- uncontrolled hypertension
- morbid obesity, that is, BMI ≥ 40
- terminal illness
- cerebrovascular disease
Show all 9Show fewer
- dementia
- heart pacemaker
- superior or inferior limb fractures.
Trial locations and contacts
1 site in 1 country.
About this study
PhotoBioModulation (PBM) is a mature science with therapeutic efficacy in humans and animals, and with excellent results in different medical specialties without side effects. However there are gaps that prevent adoption on a large scale. Recent research developed by our group and partners allowed us to understand the mechanisms of action of PBM, from Molecular Physics through Biochemistry and with consequent clinical validation, with precise, replicable and personalized therapeutic results. These findings have led to treatments for many kinds of pains with industrial predictability and accuracy, phenotypic adequacy technologies that are encapsulated, prescribed, and applied. Photobiomodulation applications cover treatments for pain, inflammation, tissue regeneration, healing, immune system activation, all of which are essential characteristics for osteoarthritis therapy. Our idea is to formulate great challenges of Photobiomodulation as a solution to osteoarthritis as follows: 1) Make PBM-based therapies as predictable as drug-based therapies; this is possible with precise dose calculation performed by our team; 2) Map the biochemical and molecular effects of PBM, including those related to gene expression; 3) Unify PBM theory by synthesizing and giving meaning to the millions of PBM data associated with osteoarthritis and correlating with clinical study to be performed under this thematic project. Overcoming these challenges, PBM will become a complementary (or supplementary) alternative to medications, physiotherapy and surgical procedures for the treatment of osteoarthritis.
Read the detailed description
Treatment Procedure Treatment was administered twice a week on the same days over a period of 5 weeks with the system Light-Aid (Bright Photomedicine, SP, Brazil), operated at continuous wave, with 100 LED of 850 nm wavelength) or with a placebo probe of same appearance and display. The irradiation parameters were customized based on the disease, pain intensity, skin phototype and BMI. The probes were numbered A (active) and B (placebo). Treatment was administered in contact to the skin over the patient's knee. Both knees were treated but statistical analysis was done only for the worst one.
Knee Pain scores Visual analogue scale (VAS) was used to evaluate pain. Patients were instructed to number their level of pain from 0 (absence of pain) to 10 (worst possible pain). The VAS was applied after each PBMT session, and weekly for sixteen weeks after treatment Quality of life Two Quality of Life (QOL) questionnaires were used: Knee injury and Osteoarthritis Outcome Score (KOOS) and World Health Organization Quality of Life-bref (WHOQOL-abbreviated). Both evaluations were recorded and compared before and after the last session of treatment.
The KOOS evaluate both short-term and long-term consequences of knee injury and OA. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
The WHOQOL assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Physical Function For functional assessments, the timed up and go test (TUG) and the sit-to-stand test (STS) were used. TUG determines fall risk and measures the progress of balance, sit to stand and walking. STS test is a method for lower extremity strength assessment. Both evaluations were recorded and compared before and after the last treatment session and the details of it can be found in supplementary material.
For the TUG and STS, patients were instructed to initiate the test at a sitting position, with the trunk in an erect posture, arms crossed over the chest, and feet on the floor. TUG is a mobility test that evaluates the time that the patient takes to get up from a chair, walk a distance of 3 m at a normal speed until he/she reaches a mark on the ground, then turn around, walk back and sit on the chair without the support of the arms. Patients were instructed to perform the sit-to-stand movements as fast as possible in 30 seconds. The number of completed sit-to-stands in 30 seconds was recorded.
- Conditions
- Osteo Arthritis Knee, Pain, Chronic, Inflammation
- Being tested
- Photobiomodulation
- Medical subject headings
- Chronic Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
The Photobiomodulation device should cover the entire knee junction, with time of application from 6 to 8 minutes and device turned on.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marucia chacur, University of Sao Paulo
- Investigators
- Nathalia Lopes Ferreira, graduate, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924128
- Sponsor's protocol ID
- 93744418.5.0000.0068
- Status last verified
- Oct 2022
- First submitted
- 17 Apr 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Photobiomodulation in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03924128
- Acronym / sponsor ID
- 93744418.5.0000.0068
- Conditions
- Osteo Arthritis Knee, Pain, Chronic, Inflammation
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- First posted
- 23 Apr 2019 (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.
PhotoBioModulation (PBM) is a mature science with therapeutic efficacy in humans and animals, and with excellent results in different medical specialties without side effects. However there are gaps that prevent adoption on a large scale. Recent research developed by our group and partners allowed us to understand the mechanisms of action of PBM, from Molecular Physics through Biochemistry and with consequent clinical validation, with precise, replicable and personalized therapeutic results. These findings have led to treatments for many kinds of pains with industrial predictability and accuracy, phenotypic adequacy technologies that are encapsulated, prescribed, and applied. Photobiomodulation applications cover treatments for pain, inflammation, tissue regeneration, healing, immune system activation, all of which are essential characteristics for osteoarthritis therapy. Our idea is to formulate great challenges of Photobiomodulation as a solution to osteoarthritis as follows: 1) Make PBM-based therapies as predictable as drug-based therapies; this is possible with precise dose calculation performed by our team; 2) Map the biochemical and molecular effects of PBM, including those related to gene expression; 3) Unify PBM theory by synthesizing and giving meaning to the millions of PBM data associated with osteoarthritis and correlating with clinical study to be performed under this thematic project. Overcoming these challenges, PBM will become a complementary (or supplementary) alternative to medications, physiotherapy and surgical procedures for the treatment of osteoarthritis.
Detailed description
Treatment Procedure Treatment was administered twice a week on the same days over a period of 5 weeks with the system Light-Aid (Bright Photomedicine, SP, Brazil), operated at continuous wave, with 100 LED of 850 nm wavelength) or with a placebo probe of same appearance and display. The irradiation parameters were customized based on the disease, pain intensity, skin phototype and BMI. The probes were numbered A (active) and B (placebo). Treatment was administered in contact to the skin over the patient's knee. Both knees were treated but statistical analysis was done only for the worst one.
Knee Pain scores Visual analogue scale (VAS) was used to evaluate pain. Patients were instructed to number their level of pain from 0 (absence of pain) to 10 (worst possible pain). The VAS was applied after each PBMT session, and weekly for sixteen weeks after treatment Quality of life Two Quality of Life (QOL) questionnaires were used: Knee injury and Osteoarthritis Outcome Score (KOOS) and World Health Organization Quality of Life-bref (WHOQOL-abbreviated). Both evaluations were recorded and compared before and after the last session of treatment.
The KOOS evaluate both short-term and long-term consequences of knee injury and OA. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
The WHOQOL assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Physical Function For functional assessments, the timed up and go test (TUG) and the sit-to-stand test (STS) were used. TUG determines fall risk and measures the progress of balance, sit to stand and walking. STS test is a method for lower extremity strength assessment. Both evaluations were recorded and compared before and after the last treatment session and the details of it can be found in supplementary material.
For the TUG and STS, patients were instructed to initiate the test at a sitting position, with the trunk in an erect posture, arms crossed over the chest, and feet on the floor. TUG is a mobility test that evaluates the time that the patient takes to get up from a chair, walk a distance of 3 m at a normal speed until he/she reaches a mark on the ground, then turn around, walk back and sit on the chair without the support of the arms. Patients were instructed to perform the sit-to-stand movements as fast as possible in 30 seconds. The number of completed sit-to-stands in 30 seconds was recorded.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects age ≥ 20 years old
- Diagnosed with Osteoarthritis stages III and IV according to the American College of Rheumatology
- Pain
- Functional impairment for more than 3 months, able to wander with or without canes.
Key exclusion criteria (9 listed)
- History of cancer
- Unstable cardiovascular disease
- uncontrolled hypertension
- morbid obesity, that is, BMI ≥ 40
- terminal illness
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 |
|---|---|---|
| PhotobiomodulationThe Photobiomodulation device should cover the entire knee junction, with time of application from 6 to 8 minutes and device turned on. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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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.
Nathalia Lopes Ferreira, graduate principal investigator
University of Sao Paulo
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 in people with Osteo Arthritis Knee and Pain, Chronic, run by University of Sao Paulo 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 9 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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. 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?
Results are not available in the source record.
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.
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 4 Nov 2022.