Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT07079969
Eligibility Criteria:
Inclusion Criteria:
* 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)
Exclusion Criteria:
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)
* 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
Renal Function
* Severe renal impairment
* History of acute kidney injury within the past 6 months
Hepatic Function
* Active liver disease or elevated liver enzymes
* Known moderate to severe hepatic impairment
* Acute or chronic liver disease such as hepatitis
Other Metabolic Conditions
* Uncontrolled diabetes
* Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site)
* Active peptic ulcers or history of recurrent peptic ulcers with complications (e.g., bleeding, perforation)
* Current use of anticoagulants with a history of gastrointestinal ulceration
Other Pain Conditions
* Chronic pain at another body site more severe than knee pain
General Health and Cognition
* Severe circulatory disorder
* Pregnancy or lactation
* Cognitive impairment that precludes informed consent or task participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
99 Years
Study:
NCT07079969
Study Brief:
Protocol Section:
NCT07079969