Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis (EPIC-KO)

NCT07079969 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB202501000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.

Conditions

Chronic Knee Pain

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

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.

Device: Sham PBM device

Interventions

Sham PBM device 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.

Also known as: placebo light therapy

Sham PBM

Photobiomodulation therapy (PBM) device 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).

Also known as: light therapy

Active PBM

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Low-Level Light Therapy; Phototherapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics

Central Study Contacts

Selenia Rubio, MD. MBA,

CONTACT

352-273-5590; srubio7@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 23, 2025
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)