[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07079969":3,"trial-entities:NCT07079969":117,"trial-summary:NCT07079969":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":85,"locations":88,"central_contacts":111,"overall_officials":114,"references":115,"see_also_links":116},"NCT07079969","IRB202501000","Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis (EPIC-KO)","Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis","NOT_YET_RECRUITING","2027-09","2026-08","2026-08-20","2026-09","University of Florida","OTHER",false,"This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.",null,[19],"Chronic Knee Pain",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","Photobiomodulation therapy (PBM) device","FDA-cleared near-infrared PBM device delivering therapeutic light to the affected knee. Administered once per session, approximately 10 minutes after topical application, in six sessions over 2-3 weeks (2-3 times per week).",[34],"Active PBM",[36],"light therapy",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"Sham PBM device","Identical in appearance to the active PBM device but emits no therapeutic light. Administered once per session, approximately 10 minutes after topical application, in six sessions over 2-3 weeks.",[41],"Sham PBM",[43],"placebo light therapy",[45],{"measure":46,"description":47,"timeFrame":48},"Change in Knee Pain Intensity (Numeric Rating Scale)","Knee pain will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Assessments will be conducted at baseline (V0) and at the final follow-up visit, one week after the last treatment session.","Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)",[],"ALL","50 Years","99 Years",{"inclusion":54,"exclusion":60,"raw_text":84},[55,56,57,58,59],"Clinically confirmed knee osteoarthritis (OA) based on the American College of Rheumatology (ACR) criteria with symptomatic pain for ≥ 3 months","Average knee-pain intensity ≥ 30\u002F100 on both the Daily Symptom Diary (DSD) run-in and CATI","Age ≥ 50 years","Ability to give informed consent, attend visits, and complete ≥ 4 of 7 DSD entries pre-randomization","Capacity to perform all study tasks (Timed Up-and-Go, knee OA assessments, blood draw, questionnaires, etc)",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Active systemic rheumatic condition (e.g., rheumatoid arthritis, systemic lupus erythematosus)","Fibromyalgia with pain outside the knee that is equal to or worse than knee pain","Clinically significant surgery on the index knee (e.g., arthroplasty, osteotomy)","Knee surgery within the past 6 weeks","Intra-articular injection to the index knee within the past 14 days","Daily opioid therapy","Hypersensitivity to PBM","Migraine triggered by light","Open wounds, skin infections, eczema, burns, or other dermatologic conditions at or near the treatment application site.","New prescription or OTC analgesic, non-pharmacologic pain therapy, chemotherapy, or radiation therapy initiated ≤ 30 days before screening","Uncontrolled hypertension (SBP \\> 150 mmHg or DBP \\> 95 mmHg)","Unstable or activity-limiting cardiovascular or peripheral arterial disease","Diagnosed neurological disorder (e.g., Parkinson's disease, multiple sclerosis, epilepsy)","History or evidence of stroke or moderate-severe traumatic brain injury","Serious psychiatric illness requiring hospitalization within the past 12 months","Active suicidal ideation","Current substance-use disorder or past hospitalization for substance-use treatment","Compromised skin integrity at or near the treatment site (e.g., open wounds, active rash, dermatitis, burns, ulcers, eczema, infection) interfering with topical treatment or PBM","Uncontrolled diabetes","Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site)","Chronic pain at another body site more severe than knee pain","Pregnancy or lactation","Cognitive impairment that precludes informed consent or task participation","Inclusion Criteria:\n\n* Clinically confirmed knee osteoarthritis (OA) based on the American College of Rheumatology (ACR) criteria with symptomatic pain for ≥ 3 months\n* Average knee-pain intensity ≥ 30\u002F100 on both the Daily Symptom Diary (DSD) run-in and CATI\n* Age ≥ 50 years\n* Ability to give informed consent, attend visits, and complete ≥ 4 of 7 DSD entries pre-randomization\n* Capacity to perform all study tasks (Timed Up-and-Go, knee OA assessments, blood draw, questionnaires, etc)\n\nExclusion Criteria:\n\nSystemic and Rheumatic Disease\n\n* Active systemic rheumatic condition (e.g., rheumatoid arthritis, systemic lupus erythematosus)\n* Fibromyalgia with pain outside the knee that is equal to or worse than knee pain\n\nMusculoskeletal History\n\n* Clinically significant surgery on the index knee (e.g., arthroplasty, osteotomy)\n* Knee surgery within the past 6 weeks\n* Intra-articular injection to the index knee within the past 14 days\n\nMedication Use\n\n* Daily opioid therapy\n* Hypersensitivity to PBM\n* Migraine triggered by light\n* Open wounds, skin infections, eczema, burns, or other dermatologic conditions at or near the treatment application site.\n* New prescription or OTC analgesic, non-pharmacologic pain therapy, chemotherapy, or radiation therapy initiated ≤ 30 days before screening\n\nCardiovascular Safety\n\n* Uncontrolled hypertension (SBP \\> 150 mmHg or DBP \\> 95 mmHg)\n* Unstable or activity-limiting cardiovascular or peripheral arterial disease\n\nNeurological and Psychiatric Conditions\n\n* Diagnosed neurological disorder (e.g., Parkinson's disease, multiple sclerosis, epilepsy)\n* History or evidence of stroke or moderate-severe traumatic brain injury\n* Serious psychiatric illness requiring hospitalization within the past 12 months\n* Active suicidal ideation\n* Current substance-use disorder or past hospitalization for substance-use treatment\n\nDermatologic Conditions\n\n* Compromised skin integrity at or near the treatment site (e.g., open wounds, active rash, dermatitis, burns, ulcers, eczema, infection) interfering with topical treatment or PBM\n\nOther Metabolic Conditions\n\n* Uncontrolled diabetes\n* Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site)\n\nOther Pain Conditions\n\n* Chronic pain at another body site more severe than knee pain\n\nGeneral Health and Cognition\n\n* Pregnancy or lactation\n* Cognitive impairment that precludes informed consent or task participation",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":13,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":108},"Gainesville","Florida","32610","United States",[95,100,103,106],{"name":96,"role":97,"phone":98,"email":99},"Selenia Rubio, MD., MBA","CONTACT","352-273-5590","srubio7@ufl.edu",{"name":101,"role":102},"Margarete C Ribeiro-Dasilva","PRINCIPAL_INVESTIGATOR",{"name":104,"role":105},"Roger B Fillingim, PhD","SUB_INVESTIGATOR",{"name":107,"role":105},"Roland Staud, MD, FACP",{"lat":109,"lon":110},29.65163,-82.32483,[112],{"name":113,"role":97,"phone":98,"email":99},"Selenia Rubio, MD. MBA,",[],[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Osteoarthritis of knee",[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This interventional study plans to enroll 30 participants. It compares an active Photobiomodulation therapy (PBM) device to a sham PBM device.","completed","Photobiomodulation for Chronic Knee Pain in Osteoarthritis","This study, called EPIC-KO, is looking at how Photobiomodulation therapy (PBM) affects pain and inflammation in people with chronic knee pain due to osteoarthritis. PBM uses a device that delivers therapeutic light to the affected knee. You would receive either the active PBM device or a sham device (which looks the same but doesn't emit light). The study aims to see if PBM can reduce knee pain intensity. To join, you need to be 50 to 99 years old, have knee osteoarthritis with pain for at least 3 months, and an average knee pain intensity of at least 30 out of 100. The study plans to enroll 30 participants, but its current status is unclear.","Your knee pain intensity will be measured from baseline up to approximately 3-4 weeks after baseline.",115,"You would receive six treatment sessions over 2-3 weeks, with each session lasting about 10 minutes after a topical application. There will be multiple visits, including a baseline and a final follow-up.","Not stated in the trial record.",[],"v2"]