Status:
TERMINATED
Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis
Lead Sponsor:
Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Collaborating Sponsors:
The Geneva Foundation
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 eval...
Detailed Description
Post Traumatic Knee Osteoarthritis (PTOA) is a degenerative joint disease resulting in the loss of cartilage due to wear and tear or by an uncharacteristic force applied to the knee. This disease appe...
Eligibility Criteria
Inclusion
- DEERS Eligible
- Between 18-64 (Inclusive)
- Civilian
- Contractor
- Active Duty Service Member
- Knee Osteoarthritis diagnosis
- a) at least 3 of the following:
- \>50 years old
- Morning stiffness \< 30 minutes
- Crepitus on active movements
- Tenderness of the bony margins of the joint
- Bony enlargement
- 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
- 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.)
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06122116
Start Date
October 13 2023
End Date
October 10 2024
Last Update
November 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Madigan Army Medical Center
Tacoma, Washington, United States, 98431