OsteoarthritisNCT05975957
Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis
A study testing Photomodulation Therapy with the Light-Aid system in people with Osteoarthritis and Gonarthrosis, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is approximately 13% in women and 10% in men. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Gonarthrosis
- What is being tested?
- Photomodulation Therapy with the Light-Aid system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2023to 31 Aug 2025
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, aged between 50 and 75 years;
- Uni or bilateral symptomatic gonarthrosis grades II or III according to the Kellgren-Lawrence classification confirmed on radiographs with weight bearing in anteroposterior, lateral and axial patella. When the disease is bilateral, the knee indicated by the patient as being the most symptomatic will be included;
- Complaint of knee pain ≥4 on the Visual Analogue Scale at the time of inclusion in the study;
- Able to walk independently, with or without walking aids;
- Cognitive ability to answer questionnaires and perform physical tests;
- Agreement to participate in the study by signing the Free and Informed Consent Form (TCLE).
Who cannot join
- Diagnosis of active malignancy except basal cell carcinoma (BCC);
- Diseases or neurological conditions that compromise the ability to perform the physical tests;
- Epilepsy;
- Skin lesions on the lower limb, close to the TFBM application site;
- Tattoos on the lower limb, close to the TFBM application site;
- Unicompartmental or total knee arthroplasty in the knee included in the study;
Show all 13Show fewer
- History of direct trauma to the knee included in the study within the last six months;
- Active systemic inflammatory disease;
- Rheumatological diseases;
- Any previous procedure with an intra-articular approach to the knee in the last six months;
- Anticipation of adopting another form of treatment during the study period, including arthroplasty;
- Patients undergoing knee shock wave treatment in the knee included in the study;
- Absence, inability or refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Glória D'Or
Rio de Janeiro, 22211-230
Maria EL Duarte, +5521981111294, maria.leite@idor.org
About this study
Official title: Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis: a Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main risk factors, in addition to age, female gender and obesity. Pharmacological treatment of gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement (arthroplasty) being reserved for more advanced forms of the disease. In general, currently available treatments have only moderate effects and low satisfaction rates among patients. Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals to treat a variety of clinical conditions, especially those associated with chronic pain. TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or Light Emitting Diodes (LED), with near-infrared wavelengths. The aim of this study is to evaluate the intensity of knee pain in the short and medium term after photobiomodulation therapy in patients with gonarthrosis. In this multicenter, randomized, placebo-controlled, double-blind clinical trial, 238 volunteers with gonarthrosis grades II and III according to the Kellgren-Lawrence classification will be recruited to be administered adjuvant treatment with TFBM. The TFBM will be performed in the knee region, twice a week, for five weeks, totaling 10 sessions. Volunteers will be allocated in the intervention group (n=119) or in the placebo group, which will be treated with 10 sessions of inert light (n=119). The hypothesis is that the photobiomodulation therapy will have a positive impact, in the short and medium term, on improving pain, functionality and quality of life of patients with symptomatic gonarthrosis.
Read the detailed description
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main risk factors, in addition to age, female gender and obesity. It can involve all three compartments of the knee and is clinically characterized by pain and progressive impairment of cartilage, bone, synovial membrane and ligaments. Pharmacological treatment of gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement (arthroplasty) being reserved for more advanced forms of the disease. In general, currently available treatments have only moderate effects and low satisfaction rates among patients. Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals to treat a variety of clinical conditions, especially those associated with chronic pain. TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or Light Emitting Diodes (LED), with near-infrared wavelengths. The technique does not emit heat, is painless and non-invasive and does not have significant side effects, and can be used as an adjuvant therapy to control pain associated with gonarthrosis. The aim of this study is to evaluate the intensity of knee pain in the short and medium term after photobiomodulation therapy in patients with gonarthrosis. In this multicenter, randomized, placebo-controlled, double-blind clinical trial, 238 volunteers with gonarthrosis grades II and III according to the Kellgren-Lawrence classification will be recruited to be administered adjuvant treatment with TFBM. The TFBM will be performed in the knee region, twice a week, for five weeks, totaling 10 sessions. Volunteers will be allocated in the intervention group (n=119) or in the placebo group, which will be treated with 10 sessions of inert light (n=119). The evaluations will be made before and after TFBM or placebo and will consist of (i) measurement of pain intensity through the application of questionnaires; (ii) verify the functional mobility of the knee joint and the muscle strength of the lower limb through physical tests; (iii) evaluate the quality of life and levels of anxiety and depression through the application of questionnaires; and (iv) record the consumption of medication for analgesic purposes and the frequency of physical therapy during the trial period. The hypothesis is that the photobiomodulation therapy will have a positive impact, in the short and medium term, on improving pain, functionality and quality of life of patients with symptomatic gonarthrosis. It is also expected to observe a reduction in pain on the Visual Analog Scale of more than 20% after 10 treatment sessions.
- Conditions
- Osteoarthritis, Gonarthrosis
- Being tested
- Photomodulation Therapy with the Light-Aid system, Control
- Keywords
- photobiomodulation, gonarthrosis, analgesia
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photomodulation Therapy with the Light-Aid systemDevice
Patients in the intervention group (FBM) will be submitted to 10 treatment sessions (twice a week/five weeks) with the Light-Aid system (Bright Photomedicine, SP, Brazil), operated in continuous mode, with 100 LEDs of 850nm wave per tip, with application time varying from 4 to 8 minutes. Irradiation parameters will be customized based on pain intensity, skin phototype and Body Mass Index (BMI).
ControlDevice
Patients in the placebo group will undergo the same therapeutic protocol as the FBM group using a device with the same appearance as the Light-Aid System, but with inert light emission. In both groups, the treatment will be administered in contact with the skin over the knee, with the patient positioned in dorsal decubitus. The three tips of the device will be positioned horizontally over the anterior region of the knee with the central tip over the patella.
| Study group | Role | What they receive |
|---|---|---|
| FBM | Experimental | volunteers who will receive adjuvant photobiomodulation therapy (n=119) Receives: Device: Photomodulation Therapy with the Light-Aid system |
| Control | Placebo comparator | volunteers who will receive placebo treatment with inert light (n=119) Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of knee pain scale by at least 20% in the FBM group assessed using the Visual Analog Scale (VAS).
The Visual Analogue Scale (VAS) evaluation is an instrument uses a scale of 0-10 to grade pain intensity, where 0 represents no pain and 10 the worst imaginable pain. The VAS will be applied daily until the 5th week of treatment and weekly from the sixth week to three months after treatment, through an online form sent daily to the patient via cell phone using an integrated application to the RedCap system or similar.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- 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
- Model description
- Prospective, multicenter randomized, double-blind, placebo-controlled clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- TERGOS PESQUISA E ENSINO S.A
- Responsible party
- Sponsor
- Investigators
- Veronica Vianna, Principal investigator, Instituto D'Or de Pesquisa e Ensino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975957
- Sponsor's protocol ID
- ID 369-22-ORTOP-IDOR-RJ-M-I
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.
PubMed 23912778Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.
PubMed 8731275Chow R, Armati P, Laakso EL, Bjordal JM, Baxter GD. Inhibitory effects of laser irradiation on peripheral mammalian nerves and relevance to analgesic effects: a systematic review. Photomed Laser Surg. 2011 Jun;29(6):365-81. doi: 10.1089/pho.2010.2928. Epub 2011 Apr 1.
PubMed 21456946Brosseau L, Welch V, Wells G, Tugwell P, de Bie R, Gam A, Harman K, Shea B, Morin M. Low level laser therapy for osteoarthritis and rheumatoid arthritis: a metaanalysis. J Rheumatol. 2000 Aug;27(8):1961-9.
PubMed 10955339Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PubMed 3377516Fukuda VO, Fukuda TY, Guimaraes M, Shiwa S, de Lima Bdel C, Martins RA, Casarotto RA, Alfredo PP, Bjordal JM, Fucs PM. SHORT-TERM EFFICACY OF LOW-LEVEL LASER THERAPY IN PATIENTS WITH KNEE OSTEOARTHRITIS: A RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL. Rev Bras Ortop. 2015 Dec 6;46(5):526-33. doi: 10.1016/S2255-4971(15)30407-9. eCollection 2011 Sep-Oct.
PubMed 27027049Geurts J, Juric D, Muller M, Scharen S, Netzer C. Novel Ex Vivo Human Osteochondral Explant Model of Knee and Spine Osteoarthritis Enables Assessment of Inflammatory and Drug Treatment Responses. Int J Mol Sci. 2018 Apr 28;19(5):1314. doi: 10.3390/ijms19051314.
PubMed 29710775Goldring SR. Alterations in periarticular bone and cross talk between subchondral bone and articular cartilage in osteoarthritis. Ther Adv Musculoskelet Dis. 2012 Aug;4(4):249-58. doi: 10.1177/1759720X12437353.
PubMed 22859924de Paula Gomes CAF, Politti F, de Souza Bacelar Pereira C, da Silva ACB, Dibai-Filho AV, de Oliveira AR, Biasotto-Gonzalez DA. Exercise program combined with electrophysical modalities in subjects with knee osteoarthritis: a randomised, placebo-controlled clinical trial. BMC Musculoskelet Disord. 2020 Apr 20;21(1):258. doi: 10.1186/s12891-020-03293-3.
PubMed 32312265de Paula Gomes CAF, Dibai-Filho AV, Politti F, de Oliveira AR, de Souza Bacelar Pereira C, da Silva ACB, Biasotto-Gonzalez DA. Photobiomodulation therapy and the clinical reality in Brazil: response to the letter to the editor. BMC Musculoskelet Disord. 2021 Jan 10;22(1):59. doi: 10.1186/s12891-020-03906-x. No abstract available.
PubMed 33423658Guimaraes LS, Costa LDCM, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Leal-Junior ECP, Costa LOP, Tomazoni SS. Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Pain. 2021 Jun 1;162(6):1612-1620. doi: 10.1097/j.pain.0000000000002189.
PubMed 33449509Hamblin MR. Mechanisms and Mitochondrial Redox Signaling in Photobiomodulation. Photochem Photobiol. 2018 Mar;94(2):199-212. doi: 10.1111/php.12864. Epub 2018 Jan 19.
PubMed 29164625GBD 2016 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1260-1344. doi: 10.1016/S0140-6736(17)32130-X.
PubMed 28919118Hedbom E, Antonsson P, Hjerpe A, Aeschlimann D, Paulsson M, Rosa-Pimentel E, Sommarin Y, Wendel M, Oldberg A, Heinegard D. Cartilage matrix proteins. An acidic oligomeric protein (COMP) detected only in cartilage. J Biol Chem. 1992 Mar 25;267(9):6132-6.
PubMed 1556121Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
PubMed 24024017
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis: a Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05975957
- Acronym / sponsor ID
- ID 369-22-ORTOP-IDOR-RJ-M-I
- Conditions
- Osteoarthritis, Gonarthrosis
- Keywords
- photobiomodulation, gonarthrosis, analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- TERGOS PESQUISA E ENSINO S.A
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 4 Aug 2023 (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.
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main risk factors, in addition to age, female gender and obesity. Pharmacological treatment of gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement (arthroplasty) being reserved for more advanced forms of the disease. In general, currently available treatments have only moderate effects and low satisfaction rates among patients. Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals to treat a variety of clinical conditions, especially those associated with chronic pain. TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or Light Emitting Diodes (LED), with near-infrared wavelengths. The aim of this study is to evaluate the intensity of knee pain in the short and medium term after photobiomodulation therapy in patients with gonarthrosis. In this multicenter, randomized, placebo-controlled, double-blind clinical trial, 238 volunteers with gonarthrosis grades II and III according to the Kellgren-Lawrence classification will be recruited to be administered adjuvant treatment with TFBM. The TFBM will be performed in the knee region, twice a week, for five weeks, totaling 10 sessions. Volunteers will be allocated in the intervention group (n=119) or in the placebo group, which will be treated with 10 sessions of inert light (n=119). The hypothesis is that the photobiomodulation therapy will have a positive impact, in the short and medium term, on improving pain, functionality and quality of life of patients with symptomatic gonarthrosis.
Detailed description
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main risk factors, in addition to age, female gender and obesity. It can involve all three compartments of the knee and is clinically characterized by pain and progressive impairment of cartilage, bone, synovial membrane and ligaments. Pharmacological treatment of gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement (arthroplasty) being reserved for more advanced forms of the disease. In general, currently available treatments have only moderate effects and low satisfaction rates among patients. Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals to treat a variety of clinical conditions, especially those associated with chronic pain. TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or Light Emitting Diodes (LED), with near-infrared wavelengths. The technique does not emit heat, is painless and non-invasive and does not have significant side effects, and can be used as an adjuvant therapy to control pain associated with gonarthrosis. The aim of this study is to evaluate the intensity of knee pain in the short and medium term after photobiomodulation therapy in patients with gonarthrosis. In this multicenter, randomized, placebo-controlled, double-blind clinical trial, 238 volunteers with gonarthrosis grades II and III according to the Kellgren-Lawrence classification will be recruited to be administered adjuvant treatment with TFBM. The TFBM will be performed in the knee region, twice a week, for five weeks, totaling 10 sessions. Volunteers will be allocated in the intervention group (n=119) or in the placebo group, which will be treated with 10 sessions of inert light (n=119). The evaluations will be made before and after TFBM or placebo and will consist of (i) measurement of pain intensity through the application of questionnaires; (ii) verify the functional mobility of the knee joint and the muscle strength of the lower limb through physical tests; (iii) evaluate the quality of life and levels of anxiety and depression through the application of questionnaires; and (iv) record the consumption of medication for analgesic purposes and the frequency of physical therapy during the trial period. The hypothesis is that the photobiomodulation therapy will have a positive impact, in the short and medium term, on improving pain, functionality and quality of life of patients with symptomatic gonarthrosis. It is also expected to observe a reduction in pain on the Visual Analog Scale of more than 20% after 10 treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, multicenter randomized, double-blind, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| FBM | Experimental | Device: Photomodulation Therapy with the Light-Aid systemvolunteers who will receive adjuvant photobiomodulation therapy (n=119) |
| Control | Placebo comparator | Device: Controlvolunteers who will receive placebo treatment with inert light (n=119) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sexes, aged between 50 and 75 years;
- Uni or bilateral symptomatic gonarthrosis grades II or III according to the Kellgren-Lawrence classification confirmed on radiographs with weight bearing in anteroposterior, lateral and axial patella. When the disease is bilateral, the knee indicated by the patient as being the most symptomatic will be included;
- Complaint of knee pain ≥4 on the Visual Analogue Scale at the time of inclusion in the study;
- Able to walk independently, with or without walking aids;
- Cognitive ability to answer questionnaires and perform physical tests;
Key exclusion criteria (13 listed)
- Diagnosis of active malignancy except basal cell carcinoma (BCC);
- Diseases or neurological conditions that compromise the ability to perform the physical tests;
- Epilepsy;
- Skin lesions on the lower limb, close to the TFBM application site;
- Tattoos on the lower limb, close to the TFBM application site;
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 |
|---|---|---|
| Photomodulation Therapy with the Light-Aid systemPatients in the intervention group (FBM) will be submitted to 10 treatment sessions (twice a week/five weeks) with the Light-Aid system (Bright Photomedicine, SP, Brazil), operated in continuous mode, with 100 LEDs of 850nm wave per tip, with application time varying from 4 to 8 minutes. Irradiation parameters will be customized based on pain intensity, skin phototype and Body Mass Index (BMI). | Device | FBM |
| ControlPatients in the placebo group will undergo the same therapeutic protocol as the FBM group using a device with the same appearance as the Light-Aid System, but with inert light emission. In both groups, the treatment will be administered in contact with the skin over the knee, with the patient positioned in dorsal decubitus. The three tips of the device will be positioned horizontally over the anterior region of the knee with the central tip over the patella. | Device | Control |
Primary outcome
Change of knee pain scale by at least 20% in the FBM group assessed using the Visual Analog Scale (VAS).
Time frame: 18 months
The Visual Analogue Scale (VAS) evaluation is an instrument uses a scale of 0-10 to grade pain intensity, where 0 represents no pain and 10 the worst imaginable pain. The VAS will be applied daily until the 5th week of treatment and weekly from the sixth week to three months after treatment, through an online form sent daily to the patient via cell phone using an integrated application to the RedCap system or similar.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 23912778Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.
- Background: PubMed 8731275Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.
- Background: PubMed 21456946Chow R, Armati P, Laakso EL, Bjordal JM, Baxter GD. Inhibitory effects of laser irradiation on peripheral mammalian nerves and relevance to analgesic effects: a systematic review. Photomed Laser Surg. 2011 Jun;29(6):365-81. doi: 10.1089/pho.2010.2928. Epub 2011 Apr 1.
- Background: PubMed 10955339Brosseau L, Welch V, Wells G, Tugwell P, de Bie R, Gam A, Harman K, Shea B, Morin M. Low level laser therapy for osteoarthritis and rheumatoid arthritis: a metaanalysis. J Rheumatol. 2000 Aug;27(8):1961-9.
- Background: PubMed 3377516Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
- Background: PubMed 27027049Fukuda VO, Fukuda TY, Guimaraes M, Shiwa S, de Lima Bdel C, Martins RA, Casarotto RA, Alfredo PP, Bjordal JM, Fucs PM. SHORT-TERM EFFICACY OF LOW-LEVEL LASER THERAPY IN PATIENTS WITH KNEE OSTEOARTHRITIS: A RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL. Rev Bras Ortop. 2015 Dec 6;46(5):526-33. doi: 10.1016/S2255-4971(15)30407-9. eCollection 2011 Sep-Oct.
- Background: PubMed 29710775Geurts J, Juric D, Muller M, Scharen S, Netzer C. Novel Ex Vivo Human Osteochondral Explant Model of Knee and Spine Osteoarthritis Enables Assessment of Inflammatory and Drug Treatment Responses. Int J Mol Sci. 2018 Apr 28;19(5):1314. doi: 10.3390/ijms19051314.
- Background: PubMed 22859924Goldring SR. Alterations in periarticular bone and cross talk between subchondral bone and articular cartilage in osteoarthritis. Ther Adv Musculoskelet Dis. 2012 Aug;4(4):249-58. doi: 10.1177/1759720X12437353.
- Background: PubMed 32312265de Paula Gomes CAF, Politti F, de Souza Bacelar Pereira C, da Silva ACB, Dibai-Filho AV, de Oliveira AR, Biasotto-Gonzalez DA. Exercise program combined with electrophysical modalities in subjects with knee osteoarthritis: a randomised, placebo-controlled clinical trial. BMC Musculoskelet Disord. 2020 Apr 20;21(1):258. doi: 10.1186/s12891-020-03293-3.
- Background: PubMed 33423658de Paula Gomes CAF, Dibai-Filho AV, Politti F, de Oliveira AR, de Souza Bacelar Pereira C, da Silva ACB, Biasotto-Gonzalez DA. Photobiomodulation therapy and the clinical reality in Brazil: response to the letter to the editor. BMC Musculoskelet Disord. 2021 Jan 10;22(1):59. doi: 10.1186/s12891-020-03906-x. No abstract available.
- Background: PubMed 33449509Guimaraes LS, Costa LDCM, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Leal-Junior ECP, Costa LOP, Tomazoni SS. Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Pain. 2021 Jun 1;162(6):1612-1620. doi: 10.1097/j.pain.0000000000002189.
- Background: PubMed 29164625Hamblin MR. Mechanisms and Mitochondrial Redox Signaling in Photobiomodulation. Photochem Photobiol. 2018 Mar;94(2):199-212. doi: 10.1111/php.12864. Epub 2018 Jan 19.
- 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.
Veronica Vianna principal investigator
Instituto D'Or de Pesquisa e Ensino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photomodulation Therapy with the Light-Aid system in people with Osteoarthritis and Gonarthrosis, run by D'Or Institute for Research and Education 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 6 inclusion and 13 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 22 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronica Vianna, Ph.D (+5521995888008, veronica.vianna@rededor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of knee pain scale by at least 20% in the FBM group assessed using the Visual Analog Scale (VAS). (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975957, which also lists 36 linked publications.
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 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.