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

ConditionChronic Knee Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-99

SponsorUniversity of Florida

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Active PBMActive comparator 1 intervention

Group B: Sham PBMSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: