Chronic Knee Pain
Conditions
Brief summary
This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.
Interventions
DEVICEPhotobiomodulation therapy (PBM) 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).
DEVICESham PBM 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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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 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) * 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 Other Metabolic Conditions * Uncontrolled diabetes * Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site) Other Pain Conditions * Chronic pain at another body site more severe than knee pain General Health and Cognition * Pregnancy or lactation * Cognitive impairment that precludes informed consent or task participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Pain Intensity (Numeric Rating Scale) | Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline) | 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. |
Countries
United States
Contacts
CONTACTSelenia Rubio, MD. MBA,
Outcome results
None listed