Clinical trial NCT06122116: Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis
Official title: Investigating Orthobiologics After Platelet-Rich Plasma and Photobiomodulation Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Sponsor class: FED
Collaborators: name: The Geneva Foundation
First posted: 2023-11-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Kellgren Lawrence Classification System (KL)
timeFrame: Baseline
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Baseline
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Daily, for 6 weeks
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Baseline
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Daily, for 6 weeks
measure: Knee Injury Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline
measure: Knee Injury Osteoarthritis Outcome Score (KOOS)
timeFrame: 3-week follow-up
measure: Knee Injury Osteoarthritis Outcome Score (KOOS)
timeFrame: 6-week follow-up
measure: The Veterans Rand 12 Item Health Survey (VR-12)
timeFrame: Baseline
measure: The Veterans Rand 12 Item Health Survey (VR-12)
timeFrame: 3-week follow-up
measure: The Veterans Rand 12 Item Health Survey (VR-12)
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 &5
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest TGF-B
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest Aggrecan
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest HYAL2
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest CRP
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest HA
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest CD14
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest CD16
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest CD64
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest CD64
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest CD16
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest CD14
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest HA
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest CRP
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest HYAL2
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest Aggrecan
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest TGF-B
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9
timeFrame: Baseline
measure: Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5
timeFrame: Baseline
measure: Biorepository Blood Draw for Biomarkers of Interest CD64.
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest CD16
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest CD14
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest HA
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest CRP
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest HYAL2
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest Aggrecan
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest TGF-B
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9
timeFrame: 6-week follow-up
measure: Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 & 5
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest TGF-B
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest Aggrecan
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest HYAL2
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest CRP
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest HA
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest CD14
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest CD16
timeFrame: 6-week follow-up
measure: Knee Joint Aspiration for Biomarkers of Interest CD64
timeFrame: 6-week follow-up
measure: Complete Blood Count (CBC) Analysis WBC
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis RBC
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis HGB
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis HCT
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis PLT
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis LYM%
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis LYM#
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis MON%
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis GRA%
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis Neutrophil%
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis Eosinophil%,
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis Basophil%
timeFrame: Baseline
measure: Complete Blood Count (CBC) Analysis MON#
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Madigan Army Medical Center
name: Scott P Grogan
role: PRINCIPAL_INVESTIGATOR
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