Chronic Knee PainEPIC-KONCT07079969
Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis (EPIC-KO)
A study testing Photobiomodulation therapy (PBM) device in people with Chronic Knee Pain, run by University of Florida at 1 site in United States.
Trial summary
This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Photobiomodulation therapy (PBM) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed knee osteoarthritis (OA) based on the American College of Rheumatology (ACR) criteria with symptomatic pain for ≥ 3 months
- Average knee-pain intensity ≥ 30/100 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)
Who cannot join
- Systemic and Rheumatic Disease
- 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
- Musculoskeletal History
- Clinically significant surgery on the index knee (e.g., arthroplasty, osteotomy)
- Knee surgery within the past 6 weeks
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- Intra-articular injection to the index knee within the past 14 days
- Medication Use
- 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
- Cardiovascular Safety
- Uncontrolled hypertension (SBP > 150 mmHg or DBP > 95 mmHg)
- Unstable or activity-limiting cardiovascular or peripheral arterial disease
- Neurological and Psychiatric Conditions
- 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
- Dermatologic Conditions
- 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
- Other Metabolic Conditions
- Uncontrolled diabetes
- Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site)
- Other Pain Conditions
- Chronic pain at another body site more severe than knee pain
- General Health and Cognition
- Pregnancy or lactation
- Cognitive impairment that precludes informed consent or task participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Florida
Gainesville, Florida, 32610
Selenia Rubio, MD., MBA, 352-273-5590, srubio7@ufl.edu
Margarete C Ribeiro-Dasilva
About this study
Official title: Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis
This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.
- Conditions
- Chronic Knee Pain
- Being tested
- Photobiomodulation therapy (PBM) device, Sham PBM device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapy (PBM) deviceDevice
Also called light therapy
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).
Sham PBM deviceDevice
Also called placebo light therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Active PBM | Active comparator | Participants will receive active photobiomodulation (PBM) delivered to peri-articular knee sites, lumbar segments L2-L5, genicular/saphenous nerve fields, and lymphatic drainage zones using the THOR® LX2.3 device and study-specified treatment parameters. Treatment will be administered in six sessions over 2-3 weeks at a frequency of 2-3 sessions per week. Receives: Device: Photobiomodulation therapy (PBM) device |
| Sham PBM | Sham comparator | Participants will receive sham photobiomodulation (PBM) delivered using a visually identical THOR® LX2.3 device that does not emit therapeutic light. Sham treatment will be administered to the same anatomical sites and according to the same treatment schedule as the active PBM group, consisting of six sessions over 2-3 weeks at a frequency of 2-3 sessions per week. Receives: Device: Sham PBM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079969
- Sponsor's protocol ID
- IRB202501000
- Acronym
- EPIC-KO
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a small, internally funded pilot study intended to assess feasibility and preliminary outcomes. IPD sharing is not planned at this stage.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07079969
- Acronym / sponsor ID
- EPIC-KO / IRB202501000
- Conditions
- Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jul 2025 (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.
This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PBM | Active comparator | Device: Photobiomodulation therapy (PBM) deviceParticipants will receive active photobiomodulation (PBM) delivered to peri-articular knee sites, lumbar segments L2-L5, genicular/saphenous nerve fields, and lymphatic drainage zones using the THOR® LX2.3 device and study-specified treatment parameters. Treatment will be administered in six sessions over 2-3 weeks at a frequency of 2-3 sessions per week. |
| Sham PBM | Sham comparator | Device: Sham PBM deviceParticipants will receive sham photobiomodulation (PBM) delivered using a visually identical THOR® LX2.3 device that does not emit therapeutic light. Sham treatment will be administered to the same anatomical sites and according to the same treatment schedule as the active PBM group, consisting of six sessions over 2-3 weeks at a frequency of 2-3 sessions per week. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically confirmed knee osteoarthritis (OA) based on the American College of Rheumatology (ACR) criteria with symptomatic pain for ≥ 3 months
- Average knee-pain intensity ≥ 30/100 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)
Key exclusion criteria (32 listed)
- Systemic and Rheumatic Disease
- 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
- Musculoskeletal History
- Clinically significant surgery on the index knee (e.g., arthroplasty, osteotomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation therapy (PBM) deviceAlso: light therapyFDA-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). | Device | Active PBM |
| Sham PBM deviceAlso: placebo light therapyIdentical 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. | Device | Sham PBM |
Primary outcome
Change in Knee Pain Intensity (Numeric Rating Scale)
Time frame: Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. This is a small, internally funded pilot study intended to assess feasibility and preliminary outcomes. IPD sharing is not planned at this stage.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (PBM) device in people with Chronic Knee Pain, run by University of Florida at 1 site in United States.
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 5 inclusion and 32 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selenia Rubio, MD. MBA, (352-273-5590, srubio7@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain Intensity (Numeric Rating Scale) (time frame: Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.