xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975957</url>
    </required_header>
    <id_info>
      <org_study_id>ID 369-22-ORTOP-IDOR-RJ-M-I</org_study_id>
      <nct_id>NCT05975957</nct_id>
    </id_info>
    <brief_title>Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis</brief_title>
    <official_title>Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis: a Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>D'Or Institute for Research and Education</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>TERGOS PESQUISA E ENSINO S.A</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>D'Or Institute for Research and Education</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which&#xD;
        directly impacts the quality of life of patients. The prevalence of OA among adults over 60&#xD;
        years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main&#xD;
        risk factors, in addition to age, female gender and obesity. Pharmacological treatment of&#xD;
        gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement&#xD;
        (arthroplasty) being reserved for more advanced forms of the disease. In general, currently&#xD;
        available treatments have only moderate effects and low satisfaction rates among patients.&#xD;
        Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals&#xD;
        to treat a variety of clinical conditions, especially those associated with chronic pain.&#xD;
        TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or&#xD;
        Light Emitting Diodes (LED), with near-infrared wavelengths. The aim of this study is to&#xD;
        evaluate the intensity of knee pain in the short and medium term after photobiomodulation&#xD;
        therapy in patients with gonarthrosis. In this multicenter, randomized, placebo-controlled,&#xD;
        double-blind clinical trial, 238 volunteers with gonarthrosis grades II and III according to&#xD;
        the Kellgren-Lawrence classification will be recruited to be administered adjuvant treatment&#xD;
        with TFBM. The TFBM will be performed in the knee region, twice a week, for five weeks,&#xD;
        totaling 10 sessions. Volunteers will be allocated in the intervention group (n=119) or in&#xD;
        the placebo group, which will be treated with 10 sessions of inert light (n=119). The&#xD;
        hypothesis is that the photobiomodulation therapy will have a positive impact, in the short&#xD;
        and medium term, on improving pain, functionality and quality of life of patients with&#xD;
        symptomatic gonarthrosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which&#xD;
        directly impacts the quality of life of patients. The prevalence of OA among adults over 60&#xD;
        years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main&#xD;
        risk factors, in addition to age, female gender and obesity. It can involve all three&#xD;
        compartments of the knee and is clinically characterized by pain and progressive impairment&#xD;
        of cartilage, bone, synovial membrane and ligaments. Pharmacological treatment of&#xD;
        gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement&#xD;
        (arthroplasty) being reserved for more advanced forms of the disease. In general, currently&#xD;
        available treatments have only moderate effects and low satisfaction rates among patients.&#xD;
        Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals&#xD;
        to treat a variety of clinical conditions, especially those associated with chronic pain.&#xD;
        TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or&#xD;
        Light Emitting Diodes (LED), with near-infrared wavelengths. The technique does not emit&#xD;
        heat, is painless and non-invasive and does not have significant side effects, and can be&#xD;
        used as an adjuvant therapy to control pain associated with gonarthrosis. The aim of this&#xD;
        study is to evaluate the intensity of knee pain in the short and medium term after&#xD;
        photobiomodulation therapy in patients with gonarthrosis. In this multicenter, randomized,&#xD;
        placebo-controlled, double-blind clinical trial, 238 volunteers with gonarthrosis grades II&#xD;
        and III according to the Kellgren-Lawrence classification will be recruited to be&#xD;
        administered adjuvant treatment with TFBM. The TFBM will be performed in the knee region,&#xD;
        twice a week, for five weeks, totaling 10 sessions. Volunteers will be allocated in the&#xD;
        intervention group (n=119) or in the placebo group, which will be treated with 10 sessions of&#xD;
        inert light (n=119). The evaluations will be made before and after TFBM or placebo and will&#xD;
        consist of (i) measurement of pain intensity through the application of questionnaires; (ii)&#xD;
        verify the functional mobility of the knee joint and the muscle strength of the lower limb&#xD;
        through physical tests; (iii) evaluate the quality of life and levels of anxiety and&#xD;
        depression through the application of questionnaires; and (iv) record the consumption of&#xD;
        medication for analgesic purposes and the frequency of physical therapy during the trial&#xD;
        period. The hypothesis is that the photobiomodulation therapy will have a positive impact, in&#xD;
        the short and medium term, on improving pain, functionality and quality of life of patients&#xD;
        with symptomatic gonarthrosis. It is also expected to observe a reduction in pain on the&#xD;
        Visual Analog Scale of more than 20% after 10 treatment sessions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective, multicenter randomized, double-blind, placebo-controlled clinical trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of knee pain scale by at least 20% in the FBM group assessed using the Visual Analog Scale (VAS).</measure>
      <time_frame>18 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">238</enrollment>
    <condition>Osteoarthritis</condition>
    <condition>Gonarthrosis</condition>
    <arm_group>
      <arm_group_label>FBM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>volunteers who will receive adjuvant photobiomodulation therapy (n=119)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>volunteers who will receive placebo treatment with inert light (n=119)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Photomodulation Therapy with the Light-Aid system</intervention_name>
      <description>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).</description>
      <arm_group_label>FBM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>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.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of both sexes, aged between 50 and 75 years;&#xD;
  &#xD;
            -  Uni or bilateral symptomatic gonarthrosis grades II or III according to the&#xD;
               Kellgren-Lawrence classification confirmed on radiographs with weight bearing in&#xD;
               anteroposterior, lateral and axial patella. When the disease is bilateral, the knee&#xD;
               indicated by the patient as being the most symptomatic will be included;&#xD;
  &#xD;
            -  Complaint of knee pain ≥4 on the Visual Analogue Scale at the time of inclusion in the&#xD;
               study;&#xD;
  &#xD;
            -  Able to walk independently, with or without walking aids;&#xD;
  &#xD;
            -  Cognitive ability to answer questionnaires and perform physical tests;&#xD;
  &#xD;
            -  Agreement to participate in the study by signing the Free and Informed Consent Form&#xD;
               (TCLE).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of active malignancy except basal cell carcinoma (BCC);&#xD;
  &#xD;
            -  Diseases or neurological conditions that compromise the ability to perform the&#xD;
               physical tests;&#xD;
  &#xD;
            -  Epilepsy;&#xD;
  &#xD;
            -  Skin lesions on the lower limb, close to the TFBM application site;&#xD;
  &#xD;
            -  Tattoos on the lower limb, close to the TFBM application site;&#xD;
  &#xD;
            -  Unicompartmental or total knee arthroplasty in the knee included in the study;&#xD;
  &#xD;
            -  History of direct trauma to the knee included in the study within the last six months;&#xD;
  &#xD;
            -  Active systemic inflammatory disease;&#xD;
  &#xD;
            -  Rheumatological diseases;&#xD;
  &#xD;
            -  Any previous procedure with an intra-articular approach to the knee in the last six&#xD;
               months;&#xD;
  &#xD;
            -  Anticipation of adopting another form of treatment during the study period, including&#xD;
               arthroplasty;&#xD;
  &#xD;
            -  Patients undergoing knee shock wave treatment in the knee included in the study;&#xD;
  &#xD;
            -  Absence, inability or refusal to sign the informed consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Veronica Vianna</last_name>
      <role>Principal Investigator</role>
      <affiliation>Instituto D'Or de Pesquisa e Ensino</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Veronica Vianna, Ph.D</last_name>
      <phone>+5521995888008</phone>
      <email>veronica.vianna@rededor.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maria EL Duarte, Ph.D</last_name>
      <phone>+5521981111294</phone>
      <email>maria.leite@idor.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Glória D'Or</name>
        <address>
          <city>Rio De Janeiro</city>
          <zip>22211-230</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria EL Duarte</last_name>
        <phone>+5521981111294</phone>
        <email>maria.leite@idor.org</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>23912778</PMID>
    </reference>
    <reference>
      <citation>Botega 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.</citation>
      <PMID>8731275</PMID>
    </reference>
    <reference>
      <citation>Chow 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.</citation>
      <PMID>21456946</PMID>
    </reference>
    <reference>
      <citation>Brosseau 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.</citation>
      <PMID>10955339</PMID>
    </reference>
    <reference>
      <citation>Fitzpatrick 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.</citation>
      <PMID>3377516</PMID>
    </reference>
    <reference>
      <citation>Fukuda 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.</citation>
      <PMID>27027049</PMID>
    </reference>
    <reference>
      <citation>Geurts 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.</citation>
      <PMID>29710775</PMID>
    </reference>
    <reference>
      <citation>Goldring 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.</citation>
      <PMID>22859924</PMID>
    </reference>
    <reference>
      <citation>de 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.</citation>
      <PMID>32312265</PMID>
    </reference>
    <reference>
      <citation>de 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.</citation>
      <PMID>33423658</PMID>
    </reference>
    <reference>
      <citation>Guimaraes 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.</citation>
      <PMID>33449509</PMID>
    </reference>
    <reference>
      <citation>Hamblin 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.</citation>
      <PMID>29164625</PMID>
    </reference>
    <reference>
      <citation>GBD 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. Erratum In: Lancet. 2017 Oct 28;390(10106):e38.</citation>
      <PMID>28919118</PMID>
    </reference>
    <reference>
      <citation>Hedbom 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.</citation>
      <PMID>1556121</PMID>
    </reference>
    <reference>
      <citation>Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.</citation>
      <PMID>24024017</PMID>
    </reference>
    <reference>
      <citation>Huang YY, Chen AC, Carroll JD, Hamblin MR. Biphasic dose response in low level light therapy. Dose Response. 2009 Sep 1;7(4):358-83. doi: 10.2203/dose-response.09-027.Hamblin.</citation>
      <PMID>20011653</PMID>
    </reference>
    <reference>
      <citation>Hunter DJ, Nevitt M, Losina E, Kraus V. Biomarkers for osteoarthritis: current position and steps towards further validation. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):61-71. doi: 10.1016/j.berh.2014.01.007.</citation>
      <PMID>24792945</PMID>
    </reference>
    <reference>
      <citation>Jaber K, O'Leary S, Pedler A, Sterling M, McAuliffe M. Evidence of generalised mechanical hyperalgesia in patients with advanced knee osteoarthritis undergoing total knee arthroplasty. Knee. 2018 Jun;25(3):459-465. doi: 10.1016/j.knee.2018.03.002. Epub 2018 Apr 21.</citation>
      <PMID>29685500</PMID>
    </reference>
    <reference>
      <citation>Ju C, Liu R, Zhang Y, Zhang F, Sun J, Lv XB, Zhang Z. Exosomes May Be the Potential New Direction of Research in Osteoarthritis Management. Biomed Res Int. 2019 Nov 3;2019:7695768. doi: 10.1155/2019/7695768. eCollection 2019.</citation>
      <PMID>31781642</PMID>
    </reference>
    <reference>
      <citation>KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.</citation>
      <PMID>13498604</PMID>
    </reference>
    <reference>
      <citation>Kobayashi T, Yoshihara Y, Yamada H, Fujikawa K. Procollagen IIC-peptide as a marker for assessing mechanical risk factors of knee osteoarthritis: effect of obesity and varus alignment. Ann Rheum Dis. 2000 Dec;59(12):982-4. doi: 10.1136/ard.59.12.982.</citation>
      <PMID>11087702</PMID>
    </reference>
    <reference>
      <citation>Langella LG, Casalechi HL, Tomazoni SS, Johnson DS, Albertini R, Pallotta RC, Marcos RL, de Carvalho PTC, Leal-Junior ECP. Photobiomodulation therapy (PBMT) on acute pain and inflammation in patients who underwent total hip arthroplasty-a randomized, triple-blind, placebo-controlled clinical trial. Lasers Med Sci. 2018 Dec;33(9):1933-1940. doi: 10.1007/s10103-018-2558-x. Epub 2018 Jun 16.</citation>
      <PMID>29909435</PMID>
    </reference>
    <reference>
      <citation>Lin YP, Su YH, Chin SF, Chou YC, Chia WT. Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial. Medicine (Baltimore). 2020 Aug 7;99(32):e21611. doi: 10.1097/MD.0000000000021611.</citation>
      <PMID>32769919</PMID>
    </reference>
    <reference>
      <citation>Liu Q, Niu J, Li H, Ke Y, Li R, Zhang Y, Lin J. Knee Symptomatic Osteoarthritis, Walking Disability, NSAIDs Use and All-cause Mortality: Population-based Wuchuan Osteoarthritis Study. Sci Rep. 2017 Jun 12;7(1):3309. doi: 10.1038/s41598-017-03110-3.</citation>
      <PMID>28607349</PMID>
    </reference>
    <reference>
      <citation>Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.</citation>
      <PMID>22392533</PMID>
    </reference>
    <reference>
      <citation>Nazari A, Moezy A, Nejati P, Mazaherinezhad A. Efficacy of high-intensity laser therapy in comparison with conventional physiotherapy and exercise therapy on pain and function of patients with knee osteoarthritis: a randomized controlled trial with 12-week follow up. Lasers Med Sci. 2019 Apr;34(3):505-516. doi: 10.1007/s10103-018-2624-4. Epub 2018 Sep 3.</citation>
      <PMID>30178432</PMID>
    </reference>
    <reference>
      <citation>Ozdemir F, Birtane M, Kokino S. The clinical efficacy of low-power laser therapy on pain and function in cervical osteoarthritis. Clin Rheumatol. 2001;20(3):181-4. doi: 10.1007/s100670170061.</citation>
      <PMID>11434469</PMID>
    </reference>
    <reference>
      <citation>Passarella S, Karu T. Absorption of monochromatic and narrow band radiation in the visible and near IR by both mitochondrial and non-mitochondrial photoacceptors results in photobiomodulation. J Photochem Photobiol B. 2014 Nov;140:344-58. doi: 10.1016/j.jphotobiol.2014.07.021. Epub 2014 Aug 21.</citation>
      <PMID>25226343</PMID>
    </reference>
    <reference>
      <citation>Podsiadlo D, Richardson S. The timed &quot;Up &amp; Go&quot;: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.</citation>
      <PMID>1991946</PMID>
    </reference>
    <reference>
      <citation>Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.</citation>
      <PMID>14613558</PMID>
    </reference>
    <reference>
      <citation>Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.</citation>
      <PMID>26439406</PMID>
    </reference>
    <reference>
      <citation>Swagerty DL Jr, Hellinger D. Radiographic assessment of osteoarthritis. Am Fam Physician. 2001 Jul 15;64(2):279-86.</citation>
      <PMID>11476273</PMID>
    </reference>
    <reference>
      <citation>Taylor DN, Winfield T, Wynd S. Low-Level Laser Light Therapy Dosage Variables vs Treatment Efficacy of Neuromusculoskeletal Conditions: A Scoping Review. J Chiropr Med. 2020 Jun;19(2):119-127. doi: 10.1016/j.jcm.2020.06.002. Epub 2020 Aug 13.</citation>
      <PMID>33318730</PMID>
    </reference>
    <reference>
      <citation>Vassao PG, de Souza ACF, da Silveira Campos RM, Garcia LA, Tucci HT, Renno ACM. Effects of photobiomodulation and a physical exercise program on the expression of inflammatory and cartilage degradation biomarkers and functional capacity in women with knee osteoarthritis: a randomized blinded study. Adv Rheumatol. 2021 Oct 16;61(1):62. doi: 10.1186/s42358-021-00220-5.</citation>
      <PMID>34656170</PMID>
    </reference>
    <reference>
      <citation>Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.</citation>
      <PMID>20170770</PMID>
    </reference>
    <reference>
      <citation>Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.</citation>
      <PMID>20699159</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>photobiomodulation</keyword>
    <keyword>gonarthrosis</keyword>
    <keyword>analgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975957
  org study id: ID 369-22-ORTOP-IDOR-RJ-M-I
  nct id: NCT05975957
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, multicenter randomized, double-blind, placebo-controlled clinical trial.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  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
  description: 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.
  arm group label: FBM
  arm group type: Experimental
  description: volunteers who will receive adjuvant photobiomodulation therapy (n=119)
  arm group label: Control
  arm group type: Placebo Comparator
  description: volunteers who will receive placebo treatment with inert light (n=119)
  intervention type: Device
  intervention name: Photomodulation Therapy with the Light-Aid system
  description: 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).
  arm group label: FBM
  intervention type: Device
  intervention name: Control
  description: 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.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Veronica Vianna
  role: Principal Investigator
  affiliation: Instituto D'Or de Pesquisa e Ensino
  last name: Veronica Vianna, Ph.D
  phone: +5521995888008
  email: veronica.vianna@rededor.org
  last name: Maria EL Duarte, Ph.D
  phone: +5521981111294
  email: maria.leite@idor.org
  facility: 
  contact: 
  country: Brazil
  citation: 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.
  PMID: 23912778
  citation: Botega 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.
  PMID: 8731275
  citation: Chow 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.
  PMID: 21456946
  citation: Brosseau 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.
  PMID: 10955339
  citation: Fitzpatrick 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.
  PMID: 3377516
  citation: Fukuda 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.
  PMID: 27027049
  citation: Geurts 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.
  PMID: 29710775
  citation: Goldring 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.
  PMID: 22859924
  citation: de 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.
  PMID: 32312265
  citation: de 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.
  PMID: 33423658
  citation: Guimaraes 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.
  PMID: 33449509
  citation: Hamblin 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.
  PMID: 29164625
  citation: GBD 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. Erratum In: Lancet. 2017 Oct 28;390(10106):e38.
  PMID: 28919118
  citation: Hedbom 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.
  PMID: 1556121
  citation: Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
  PMID: 24024017
  citation: Huang YY, Chen AC, Carroll JD, Hamblin MR. Biphasic dose response in low level light therapy. Dose Response. 2009 Sep 1;7(4):358-83. doi: 10.2203/dose-response.09-027.Hamblin.
  PMID: 20011653
  citation: Hunter DJ, Nevitt M, Losina E, Kraus V. Biomarkers for osteoarthritis: current position and steps towards further validation. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):61-71. doi: 10.1016/j.berh.2014.01.007.
  PMID: 24792945
  citation: Jaber K, O'Leary S, Pedler A, Sterling M, McAuliffe M. Evidence of generalised mechanical hyperalgesia in patients with advanced knee osteoarthritis undergoing total knee arthroplasty. Knee. 2018 Jun;25(3):459-465. doi: 10.1016/j.knee.2018.03.002. Epub 2018 Apr 21.
  PMID: 29685500
  citation: Ju C, Liu R, Zhang Y, Zhang F, Sun J, Lv XB, Zhang Z. Exosomes May Be the Potential New Direction of Research in Osteoarthritis Management. Biomed Res Int. 2019 Nov 3;2019:7695768. doi: 10.1155/2019/7695768. eCollection 2019.
  PMID: 31781642
  citation: KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
  PMID: 13498604
  citation: Kobayashi T, Yoshihara Y, Yamada H, Fujikawa K. Procollagen IIC-peptide as a marker for assessing mechanical risk factors of knee osteoarthritis: effect of obesity and varus alignment. Ann Rheum Dis. 2000 Dec;59(12):982-4. doi: 10.1136/ard.59.12.982.
  PMID: 11087702
  citation: Langella LG, Casalechi HL, Tomazoni SS, Johnson DS, Albertini R, Pallotta RC, Marcos RL, de Carvalho PTC, Leal-Junior ECP. Photobiomodulation therapy (PBMT) on acute pain and inflammation in patients who underwent total hip arthroplasty-a randomized, triple-blind, placebo-controlled clinical trial. Lasers Med Sci. 2018 Dec;33(9):1933-1940. doi: 10.1007/s10103-018-2558-x. Epub 2018 Jun 16.
  PMID: 29909435
  citation: Lin YP, Su YH, Chin SF, Chou YC, Chia WT. Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial. Medicine (Baltimore). 2020 Aug 7;99(32):e21611. doi: 10.1097/MD.0000000000021611.
  PMID: 32769919
  citation: Liu Q, Niu J, Li H, Ke Y, Li R, Zhang Y, Lin J. Knee Symptomatic Osteoarthritis, Walking Disability, NSAIDs Use and All-cause Mortality: Population-based Wuchuan Osteoarthritis Study. Sci Rep. 2017 Jun 12;7(1):3309. doi: 10.1038/s41598-017-03110-3.
  PMID: 28607349
  citation: Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.
  PMID: 22392533
  citation: Nazari A, Moezy A, Nejati P, Mazaherinezhad A. Efficacy of high-intensity laser therapy in comparison with conventional physiotherapy and exercise therapy on pain and function of patients with knee osteoarthritis: a randomized controlled trial with 12-week follow up. Lasers Med Sci. 2019 Apr;34(3):505-516. doi: 10.1007/s10103-018-2624-4. Epub 2018 Sep 3.
  PMID: 30178432
  citation: Ozdemir F, Birtane M, Kokino S. The clinical efficacy of low-power laser therapy on pain and function in cervical osteoarthritis. Clin Rheumatol. 2001;20(3):181-4. doi: 10.1007/s100670170061.
  PMID: 11434469
  citation: Passarella S, Karu T. Absorption of monochromatic and narrow band radiation in the visible and near IR by both mitochondrial and non-mitochondrial photoacceptors results in photobiomodulation. J Photochem Photobiol B. 2014 Nov;140:344-58. doi: 10.1016/j.jphotobiol.2014.07.021. Epub 2014 Aug 21.
  PMID: 25226343
  citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
  PMID: 1991946
  citation: Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
  PMID: 14613558
  citation: Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.
  PMID: 26439406
  citation: Swagerty DL Jr, Hellinger D. Radiographic assessment of osteoarthritis. Am Fam Physician. 2001 Jul 15;64(2):279-86.
  PMID: 11476273
  citation: Taylor DN, Winfield T, Wynd S. Low-Level Laser Light Therapy Dosage Variables vs Treatment Efficacy of Neuromusculoskeletal Conditions: A Scoping Review. J Chiropr Med. 2020 Jun;19(2):119-127. doi: 10.1016/j.jcm.2020.06.002. Epub 2020 Aug 13.
  PMID: 33318730
  citation: Vassao PG, de Souza ACF, da Silveira Campos RM, Garcia LA, Tucci HT, Renno ACM. Effects of photobiomodulation and a physical exercise program on the expression of inflammatory and cartilage degradation biomarkers and functional capacity in women with knee osteoarthritis: a randomized blinded study. Adv Rheumatol. 2021 Oct 16;61(1):62. doi: 10.1186/s42358-021-00220-5.
  PMID: 34656170
  citation: Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
  PMID: 20170770
  citation: Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
  PMID: 20699159
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Inflammation
  sharing ipd: No