Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Biological: Platelet-Rich Plasma Injection; Other: Physical Therapy; Device: Photobiomodulation Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06122116

Photomedicine Project 11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Physical Therapy (PT) Only

Active Comparator group

Description:

All participants will complete a standard of care PT program addressing individual strength, mobility, and flexibility deficits in both proximal and distal muscle groups. The provider may also use other modalities to address distal issues. If a participant has not been placed on profile at the time of consent, a profile may be written by the study medical provider to ensure limitation of activities, as appropriate.

Treatment:

Other: Physical Therapy

PT + Platelet-Rich Plasma (PRP)

Active Comparator group

Description:

PRP Preparation: The PRP will be prepared following standard technique by drawing 60cc blood from the participant through venipuncture and spinning the blood sample in a centrifuge (for approximately 17 minutes), adjusting for leukocyte poor-platelet rich plasma (LP-PRP). This sample will be prepared by the study provider. Any leftover blood will be safely discarded per standard protocols. A small portion of the pre-spin whole blood (approximately 1 cc) and post-spin injectant PRP (approximately 1 cc) will be sent to MAMC Department of Pathology and Laboratory Services (DPALS) for complete blood count (CBC) cytology to monitor standardization and reproducibility. This portion will be labeled by participant ID and study. De-identified hardcopy results will be obtained from MAMC DPALS, and CBC results will be reported on Appendix G (CBC Results CRF). Post-procedural instructions will be provided in a participant handout.

Treatment:

Other: Physical Therapy

Biological: Platelet-Rich Plasma Injection

PT + Photobiomodulation Treatment (PBMT)

Active Comparator group

Description:

In addition to SOC PT, the PBMT group will receive PBM treatment, as outlined below. PBM treatments will occur 3 times each week, for 3 weeks. A member of the study team will measure the treatment area according to a standard protocol and calculate the treatment time (approximately 5-20 minutes). PBMT will be delivered at 6 J/cm2 and 25W and applied in a serpentine pattern to the knee area. Participants will be asked to refrain from using perfumes or plant extracts (e.g., St. John's Wort) in the treatment area(s), as this can increase skin photosensitivity.

Treatment:

Device: Photobiomodulation Therapy

Other: Physical Therapy

PT + PRP + PBMT

Active Comparator group

Description:

In addition to SOC PT, the PRP and PBMT group will receive PRP treatment and PBMT treatments. Participants in this group will start PBMT treatments on the same day after receiving the study PRP injection. On the day of the PRP injection, the participant will be instructed to rest for 5-10 minutes prior to the PBMT application and team member will ensure the participant is comfortable not in pain. Immediately following the study injection, the team member will take care not to provide the PBMT over the injected area; however, all subsequent PBMT treatments will be delivered to the knee where the PRP was injected.

Treatment:

Device: Photobiomodulation Therapy

Other: Physical Therapy

Biological: Platelet-Rich Plasma Injection