Investigating Orthobiologics After Platelet-Rich Plasma and Photobiomodulation Treatment of Knee Osteoarthritis

Photomedicine Project 11

This research assesses the effects that Photobiomodulation Therapy (PBMT) has on Intra-articular administered Plasma-Rich Platelet (PRP) injections for Knee Osteoarthritis (KOA) treatment through evaluations of synovial and serum inflammatory and reparative biomarkers. A comparison of Physical Therapy (PT) vs PT + PRP vs PT + PBMT vs PT + PRP + PBMT for KOA treatment is made. The relationship between self-reported pain and functionality and treatment mechanisms is analyzed along with an analysis of the intersectionality between participant self-reported pain and functionality and medicine markers across treatment groups. These aims seek to inform current treatment practices in treating KOA and returning Active-Duty Service Members to duty readiness.

2023-10-13

2024-05-10

2024-05-10

Recruiting

150

Inclusion Criteria: * DEERS Eligible * Between 18-64 (Inclusive) * Civilian * Contractor * Active Duty Service Member * Knee Osteoarthritis diagnosis a) at least 3 of the following: 1. \>50 years old 2. Morning stiffness \< 30 minutes 3. Crepitus on active movements 4. Tenderness of the bony margins of the joint 5. Bony enlargement 6. No palpable warmth * Fluent in speaking and reading English * Ability to commit to study intervention and follow-up * Willing to avoid prohibited treatments while enrolled in the study (NSAIDs/COX-2 inhibitors and ASAs for 5 days prior to and 2 weeks following study injection or beginning of treatment, and oral steroids, steroid injections, and viscos supplementation) * Radiographic evidence of knee osteoarthritis as assessed by Kellgren-Lawrence grade 1 or higher Exclusion Criteria: * Current participation in other research studies for knee OA * Previous enrollment for contralateral knee * Hx of arthroscopic surgery on the study knee within the past year * Hx of arthroplasty on the study knee * Received dry needling within the past 4 weeks * Received prolotherapy (e.g. CSI or PRP injection), within past month * Recent (within the last 3 months) lower extremity injury (e.g., ankle sprain, meniscus tear or sprain, etc.) that required professional medical attention, and occurred in the ipsilateral extremity of the study knee * Confounding, coexisting pathology suspected to be the primary source of their pain \[e.g., acute meniscal tear (with mechanical symptoms), ligamentous changes (with clinical instability) or hemarthrosis\] * Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling * Diagnosis of neuropathy affecting sensation to pain * Diagnosis of inflammatory arthropathy * Diagnosis of fibromyalgia or chronic fatigue syndrome * Hx of adverse reaction to PRP injection (either documented in the medical record or shared by the patient during screening) * Tattoo in treatment area * Diagnosis of porphyria (light induced allergy) or photosensitive eczema * Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole) * Current use of pacemaker * Hx of underlying cardiac disease * Diagnosis of autoimmune disease * Albinism * Current pregnancy or plans to become pregnant during intervention period * Hx of memory problems, dementia, and/or impaired decision-making ability * Any other serious medical conditions(s) that might preclude optimal outcome and/or interfere with participation (e.g.), intra-articular sepsis, bacteremia, fracture, joint instability, rheumatoid arthritis, osteoporosis, cancer, coagulopathy, etc.)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-02-07