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

NCT07079969 | Not Yet Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: IRB202501000
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of combined treatments-dual-wavelength photobiomodulation (PBM) with or without topical diclofenac-on inflammation, pain, and joint function in patients with knee osteoarthritis (OA). It also seeks to determine the synergistic effect of PBM plus topical diclofenac on inflammatory markers, pain scores, and functional outcomes.

Conditions

Knee Pain Chronic

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 (4)

PBM Only

EXPERIMENTAL

Participants will receive placebo topical cream (identical in appearance to diclofenac sodium 1% gel), applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive active photobiomodulation therapy (PBM) using an FDA-cleared near-infrared device. PBM will be administered approximately 10 minutes after placebo cream application. Both treatments will be delivered in six sessions over a 2-3 week period, at a frequency of 2-3 times per week.

Device: Photobiomodulation therapy (PBM) device; Drug: Placebo topical cream

Diclofenac only

EXPERIMENTAL

Participants will receive diclofenac sodium 1% topical cream, applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive sham PBM using a device identical in appearance to the active PBM device but without therapeutic light output. Sham PBM will be administered approximately 10 minutes after diclofenac cream application. Both treatments will be delivered in six sessions over 2-3 weeks, at a frequency of 2-3 times per week.

Device: Sham PBM device; Drug: Diclofenac Sodium 1 % Topical Cream

Combined

EXPERIMENTAL

Participants will receive diclofenac sodium 1% topical cream, applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive active PBM using the same device and parameters described above. PBM will be administered approximately 10 minutes after diclofenac cream application. Both treatments will be delivered in six sessions over 2-3 weeks, at a frequency of 2-3 times per week.

Device: Photobiomodulation therapy (PBM) device; Drug: Diclofenac Sodium 1 % Topical Cream

Double placebo

PLACEBO COMPARATOR

Participants will receive placebo topical cream, applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive sham PBM using a visually identical device that does not emit therapeutic light. Sham PBM will be administered approximately 10 minutes after placebo cream application. Both treatments will be delivered in six sessions over 2-3 weeks, at a frequency of 2-3 times per week.

Device: Sham PBM device; Drug: Placebo topical cream

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

Diclofenac only; Double placebo

Placebo topical cream DRUG

Inert cream matching the appearance of diclofenac sodium 1% gel. Applied at 4 grams to the affected knee, once per session, immediately before PBM/sham PBM. Used in six sessions over 2-3 weeks

Also known as: Vehicle cream

Double placebo; PBM Only

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

Combined; PBM Only

Diclofenac Sodium 1 % Topical Cream DRUG

Topical nonsteroidal anti-inflammatory drug applied at a dose of 4 grams to the affected knee, once per session, immediately before PBM/sham PBM. Used in six sessions over 2-3 weeks.

Also known as: Voltaren, NSAID topical cream

Combined; Diclofenac only

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 or allergy to diclofenac, other NSAIDs, or PBM
• Use of centrally acting sodium-channel blockers or NMDA-receptor antagonists
• New prescription or OTC analgesic, non-pharmacologic pain therapy, investigational drug, chemotherapy, or radiation therapy initiated ≤ 30 days before screening
• Clinically significant drug interaction between topical diclofenac and concomitant medications per Drugs.com Drug Interaction Checker
• 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; Diclofenac

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Selenia Rubio, MD. MBA,

CONTACT

352-273-5590; srubio7@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)