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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07079969
Status
Not Yet Recruiting

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Conditions

  • Chronic Knee Pain

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).
  • 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.

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active PBM
    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.
  • Sham Comparator: Sham PBM
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Selenia Rubio, MD., MBA
[email protected]
352-273-5590
Margarete C Ribeiro-Dasilva (PRINCIPAL_INVESTIGATOR)
Roger B Fillingim, PhD (SUB_INVESTIGATOR)
Roland Staud, MD, FACP (SUB_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FL

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