NCT06122116

Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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 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.

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 appears frequently in Active-Duty Service Members and is rising in prominence where over 20,000 Knee Osteoarthritis (KOA) cases were detected over a 10-year period. Current treatments such as physical therapy (PT), braces, oral pain relievers, corticosteroid, and hyaluronic acid injections for KOA only address the quality of life and the symptoms but have not demonstrated a reverse in disease progression. Studies have found that Platelet-Rich Plasma (PRP) has shown to be a promising treatment 6-12 months post procedure and may slow KOA progression. Photobiomodulation therapy (PBMT) is a non-invasive treatment option shown to reduce pain, increase function, and decrease stiffness with or without therapeutic exercises in KOA patients. In combination, PRP and PBMT may increase the recovery benefits while and potentially reduce KOA progression while seeking therapy. The exact dosage for the optimization of treatment with both PRP and PBMT still needs to be analyzed and understood. Therefore, this study will investigate four treatment arms utilizing PT, PT plus PRP, PT plus PBMT, and PT plus PRP plus PBMT. This discover based and randomized control trial will investigate the effect of PBMT and intra-articular administered PRP treatment on clinical outcomes (e.g., pain scores) and biomolecular signatures (DNA, RNA, or protein levels) in the blood or synovial spaces.The participants' intersectionality between pain, functionality, and precision medicine markers will be analyzed across treatment groups. Follow-up data in the form of questionnaires and activity logs will be collected to monitor study progression.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Physical Therapy	The PT treatment participants receive in this study will be standard of care; that is, the PT treatment regimen will not be standardized across study participants and/or dictated by study-specific criteria. Participants will be referred to the Physical Therapy Department at the Madigan Army Medical Center (MAMC). Number of PT treatments will be documented on a follow-up Chart Review.
BIOLOGICAL	Platelet-Rich Plasma Injection	PRP injection procedures will follow current clinical recommendation and standard operating procedures. Prior to the injection, the area will be sterilely prepared and anesthetized with either ethyl chloride spray or lidocaine (limited to the cutaneous and subcutaneous layer, so as not to alter the synovial contents). Then, the participant will receive LP-PRP injection in the affected knee area under ultrasound guidance. Qualified study providers will inject 2-5cc LP-PRP using an 18-gauge 1/5-inch needle for both aspiration and subsequent injection. Study providers will select the injection portal they are most comfortable with, in order to achieve an accurate intra-articular injection. The PRP injection procedure is expected to take approximately one hour.
DEVICE	Photobiomodulation Therapy	PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. PBMT will be delivered at 6 J/cm\^2 and applied in a circular pattern to the knee area.

Timeline

• Start date: 2023-10-13
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2023-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study