Knee OsteoarthritisNCT06122116
Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis
A study testing Physical Therapy, Platelet-Rich Plasma Injection and Photobiomodulation Therapy in people with Knee Osteoarthritis, run by Musculoskeletal Injury Rehabilitation Research for Operational Readiness at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Physical Therapy, Platelet-Rich Plasma Injection and Photobiomodulation Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2023to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DEERS Eligible
- Between 18-64 (Inclusive)
- Civilian
- Contractor
- Active Duty Service Member
- Knee Osteoarthritis diagnosis
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Investigating Orthobiologics After Platelet-Rich Plasma and Photobiomodulation Treatment of Knee Osteoarthritis
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.
Read the 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
- Being tested
- Physical Therapy, Platelet-Rich Plasma Injection, Photobiomodulation Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Also called SOC PT
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.
Platelet-Rich Plasma InjectionBiological
Also called PRP
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.
Photobiomodulation TherapyDevice
Also called PBMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy (PT) Only | Active comparator | 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. Receives: Other: Physical Therapy |
| PT + Platelet-Rich Plasma (PRP) | Active comparator | 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. Receives: Other: Physical Therapy; Biological: Platelet-Rich Plasma Injection |
| PT + Photobiomodulation Treatment (PBMT) | Active comparator | 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. Receives: Other: Physical Therapy; Device: Photobiomodulation Therapy |
| PT + PRP + PBMT | Active comparator | 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. Receives: Other: Physical Therapy; Biological: Platelet-Rich Plasma Injection; Device: Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kellgren Lawrence Classification System (KL)
Kellgren Lawrence Classification System (KL) will score the radiographic evidence of the participant's knee osteoarthritis.
Minimum Score: Grade 0 (none): definite absence of X-ray changes of knee OA
Maximum Score: Grade 4 (severe): Large osteophyte formation, joint space narrowing, definite bone end deformity
Higher grades indicate a worse outcome.
Measured: Baseline
Defense and Veterans Pain Rating Scale (DVPRS)
Defense and Veterans Pain Rating Scale (DVPRS) will capture current pain severity.
Minimum Score: 0 (no pain)
Maximum Score: 10 (As bad as it could be, nothing else matters)
A higher score indicates, increasing pain.
Measured: Baseline
Defense and Veterans Pain Rating Scale (DVPRS)
Defense and Veterans Pain Rating Scale (DVPRS) will capture current pain severity.
Minimum Score: 0 (no pain)
Maximum Score: 10 (As bad as it could be, nothing else matters)
A higher score indicates, increasing pain.
Measured: Daily, for 6 weeks
Single Assessment Numeric Evaluation (SANE)
Single Assessment Numeric Evaluation (SANE) will rate the participant's knee osteoarthritis condition as a percentage from normal.
Minimum Score: 0% (Abnormal)
Maximum Score: 100% (Fully Normal)
An increasing percentage means the closer the participant feels their knee is back to normal function.
Measured: Baseline
Single Assessment Numeric Evaluation (SANE)
Single Assessment Numeric Evaluation (SANE) will rate the participant's knee osteoarthritis condition as a percentage from normal.
Minimum Score: 0% (Abnormal)
Maximum Score: 100% (Fully Normal)
An increasing percentage means the closer the participant feels their knee is back to normal function.
Measured: Daily, for 6 weeks
Knee Injury Osteoarthritis Outcome Score (KOOS)
Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week.
Minimum Score: None
Maximum Score: Extreme
On a per question basis, the participant states how significant their knee symptoms are.
Measured: Baseline
Knee Injury Osteoarthritis Outcome Score (KOOS)
Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week.
Minimum Score: None
Maximum Score: Extreme
On a per question basis, the participant states how significant their knee symptoms are.
Measured: 3-week follow-up
Knee Injury Osteoarthritis Outcome Score (KOOS)
Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week.
Minimum Score: None
Maximum Score: Extreme
On a per question basis, the participant states how significant their knee symptoms are.
Measured: 6-week follow-up
The Veterans Rand 12 Item Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey (VR-12) asks participants about their feelings and how well they can do their usual activities.
Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health.
Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them.
Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities.
Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work.
Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted.
Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.
Measured: Baseline
The Veterans Rand 12 Item Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey (VR-12) will ask participants about how they feel and how well they are able to do their usual activities.
Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health.
Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them.
Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities.
Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work.
Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted.
Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.
Measured: 3-week follow-up
The Veterans Rand 12 Item Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey (VR-12) will ask participants about how they feel and how well they are able to do their usual activities.
Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health.
Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them.
Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities.
Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work.
Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted.
Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 &5
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \&5.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 \& 9.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest TGF-B
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest Aggrecan
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest HYAL2
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest CRP
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest HA
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest CD14
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest CD16
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest CD64
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest CD64
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest CD16
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest CD14
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest HA
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest CRP
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest HYAL2
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest Aggrecan
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest TGF-B
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7\& 9.
Measured: Baseline
Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \& 5.
Measured: Baseline
Biorepository Blood Draw for Biomarkers of Interest CD64.
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest CD16
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest CD14
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest HA
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest CRP
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest HYAL2
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest Aggrecan
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest TGF-B
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 \& 9.
Measured: 6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 & 5
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \& 5.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \& 5.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 \& 9.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest TGF-B
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest Aggrecan
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest HYAL2
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CRP
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest HA
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CD14
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CD16
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Measured: 6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CD64
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Measured: 6-week follow-up
Complete Blood Count (CBC) Analysis WBC
Whole blood and PRP spin analysis will be completed to analyze total blood content of WBC.
Measured: Baseline
Complete Blood Count (CBC) Analysis RBC
Whole blood and PRP spin analysis will be completed to analyze total blood content of RBC.
Measured: Baseline
Complete Blood Count (CBC) Analysis HGB
Whole blood and PRP spin analysis will be completed to analyze total blood content of HGB.
Measured: Baseline
Complete Blood Count (CBC) Analysis HCT
Whole blood and PRP spin analysis will be completed to analyze total blood content of HCT.
Measured: Baseline
Complete Blood Count (CBC) Analysis PLT
Whole blood and PRP spin analysis will be completed to analyze total blood content of PLT.
Measured: Baseline
Complete Blood Count (CBC) Analysis LYM%
Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM%.
Measured: Baseline
Complete Blood Count (CBC) Analysis LYM#
Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM#.
Measured: Baseline
Complete Blood Count (CBC) Analysis MON%
Whole blood and PRP spin analysis will be completed to analyze total blood content of MON%.
Measured: Baseline
Complete Blood Count (CBC) Analysis GRA%
Whole blood and PRP spin analysis will be completed to analyze total blood content of GRA%.
Measured: Baseline
Complete Blood Count (CBC) Analysis Neutrophil%
Whole blood and PRP spin analysis will be completed to analyze total blood content of Neutrophil%.
Measured: Baseline
Complete Blood Count (CBC) Analysis Eosinophil%,
Whole blood and PRP spin analysis will be completed to analyze total blood content of Eosinophil%.
Measured: Baseline
Complete Blood Count (CBC) Analysis Basophil%
Whole blood and PRP spin analysis will be completed to analyze total blood content of Basophil%.
Measured: Baseline
Complete Blood Count (CBC) Analysis MON#
Whole blood and PRP spin analysis will be completed to analyze total blood content of MON#.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start13 Oct 2023
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Why it stopped: The Institutional Review Board terminated the protocol on 10 October 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational Readiness
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation
- Responsible party
- Sponsor
- Investigators
- Scott P Grogan, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122116
- Sponsor's protocol ID
- Photomedicine Project 11
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Arnoczky SP, Sheibani-Rad S. The basic science of platelet-rich plasma (PRP): what clinicians need to know. Sports Med Arthrosc Rev. 2013 Dec;21(4):180-5. doi: 10.1097/JSA.0b013e3182999712.
PubMed 24212364Assis L, Milares LP, Almeida T, Tim C, Magri A, Fernandes KR, Medalha C, Renno AC. Aerobic exercise training and low-level laser therapy modulate inflammatory response and degenerative process in an experimental model of knee osteoarthritis in rats. Osteoarthritis Cartilage. 2016 Jan;24(1):169-77. doi: 10.1016/j.joca.2015.07.020. Epub 2015 Aug 5.
PubMed 26254236Blank ML, Cress EA, Snyder F. Separation and quantitation of phospholipid subclasses as their diradylglycerobenzoate derivatives by normal-phase high-performance liquid chromatography. J Chromatogr. 1987 Apr 17;392:421-5. doi: 10.1016/s0021-9673(01)94286-4. No abstract available.
PubMed 3597586Cook CS, Smith PA. Clinical Update: Why PRP Should Be Your First Choice for Injection Therapy in Treating Osteoarthritis of the Knee. Curr Rev Musculoskelet Med. 2018 Dec;11(4):583-592. doi: 10.1007/s12178-018-9524-x.
PubMed 30350299Dhillon MS, Patel S, John R. PRP in OA knee - update, current confusions and future options. SICOT J. 2017;3:27. doi: 10.1051/sicotj/2017004. Epub 2017 Mar 22.
PubMed 28322719Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.
PubMed 32503238Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.
PubMed 32551947Goncalves AB, Bovo JL, Gomes BS, Pigoso AA, Felonato M, Esquisatto MAM, Filho GJL, do Bomfim FRC. Photobiomodulation (lambda=808nm) and Platelet-Rich Plasma (PRP) for the Treatment of Acute Rheumatoid Arthritis in Wistar Rats. J Lasers Med Sci. 2021 Oct 18;12:e60. doi: 10.34172/jlms.2021.60. eCollection 2021.
PubMed 35155145Hamblin M, Demidova-Rice TN. Cellular chromophores and signaling in low level light therapy. In Biomedical Optics 2007
Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/
PubMed 29939661Huang G, Hua S, Yang T, Ma J, Yu W, Chen X. Platelet-rich plasma shows beneficial effects for patients with knee osteoarthritis by suppressing inflammatory factors. Exp Ther Med. 2018 Mar;15(3):3096-3102. doi: 10.3892/etm.2018.5794. Epub 2018 Jan 24.
PubMed 29599843Ip D. Does addition of low-level laser therapy (LLLT) in conservative care of knee arthritis successfully postpone the need for joint replacement? Lasers Med Sci. 2015 Dec;30(9):2335-9. doi: 10.1007/s10103-015-1814-6. Epub 2015 Sep 29.
PubMed 26420240Migliorini F, Driessen A, Quack V, Sippel N, Cooper B, Mansy YE, Tingart M, Eschweiler J. Comparison between intra-articular infiltrations of placebo, steroids, hyaluronic and PRP for knee osteoarthritis: a Bayesian network meta-analysis. Arch Orthop Trauma Surg. 2021 Sep;141(9):1473-1490. doi: 10.1007/s00402-020-03551-y. Epub 2020 Jul 28.
PubMed 32725315Molloy JM, Pendergrass TL, Lee IE, Chervak MC, Hauret KG, Rhon DI. Musculoskeletal Injuries and United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. Mil Med. 2020 Sep 18;185(9-10):e1461-e1471. doi: 10.1093/milmed/usaa027.
PubMed 32175566Ng NT, Heesch KC, Brown WJ. Strategies for managing osteoarthritis. Int J Behav Med. 2012 Sep;19(3):298-307. doi: 10.1007/s12529-011-9168-3.
PubMed 21614451
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Orthobiologics After Platelet-Rich Plasma and Photobiomodulation Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06122116
- Acronym / sponsor ID
- Photomedicine Project 11
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Institutional Review Board terminated the protocol on 10 October 2024.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational ReadinessUS federal agency
- Collaborators
- The Geneva Foundation
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy (PT) Only | Active comparator | Other: Physical TherapyAll 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. |
| PT + Platelet-Rich Plasma (PRP) | Active comparator | Other: Physical Therapy, Biological: Platelet-Rich Plasma InjectionPRP 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. |
| PT + Photobiomodulation Treatment (PBMT) | Active comparator | Other: Physical Therapy, Device: Photobiomodulation TherapyIn 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. |
| PT + PRP + PBMT | Active comparator | Other: Physical Therapy, Biological: Platelet-Rich Plasma Injection, Device: Photobiomodulation TherapyIn 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- DEERS Eligible
- Between 18-64 (Inclusive)
- Civilian
- Contractor
- Active Duty Service Member
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyAlso: SOC PTThe 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. | Other | PT + PRP + PBMT, PT + Photobiomodulation Treatment (PBMT), PT + Platelet-Rich Plasma (PRP), Physical Therapy (PT) Only |
| Platelet-Rich Plasma InjectionAlso: PRPPRP 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. | Biological | PT + PRP + PBMT, PT + Platelet-Rich Plasma (PRP) |
| Photobiomodulation TherapyAlso: PBMTPBMT 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. | Device | PT + PRP + PBMT, PT + Photobiomodulation Treatment (PBMT) |
Primary outcome
Kellgren Lawrence Classification System (KL)
Time frame: Baseline
Kellgren Lawrence Classification System (KL) will score the radiographic evidence of the participant's knee osteoarthritis. Minimum Score: Grade 0 (none): definite absence of X-ray changes of knee OA Maximum Score: Grade 4 (severe): Large osteophyte formation, joint space narrowing, definite bone end deformity Higher grades indicate a worse outcome.
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: Baseline
Defense and Veterans Pain Rating Scale (DVPRS) will capture current pain severity. Minimum Score: 0 (no pain) Maximum Score: 10 (As bad as it could be, nothing else matters) A higher score indicates, increasing pain.
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: Daily, for 6 weeks
Defense and Veterans Pain Rating Scale (DVPRS) will capture current pain severity. Minimum Score: 0 (no pain) Maximum Score: 10 (As bad as it could be, nothing else matters) A higher score indicates, increasing pain.
Single Assessment Numeric Evaluation (SANE)
Time frame: Baseline
Single Assessment Numeric Evaluation (SANE) will rate the participant's knee osteoarthritis condition as a percentage from normal. Minimum Score: 0% (Abnormal) Maximum Score: 100% (Fully Normal) An increasing percentage means the closer the participant feels their knee is back to normal function.
Single Assessment Numeric Evaluation (SANE)
Time frame: Daily, for 6 weeks
Single Assessment Numeric Evaluation (SANE) will rate the participant's knee osteoarthritis condition as a percentage from normal. Minimum Score: 0% (Abnormal) Maximum Score: 100% (Fully Normal) An increasing percentage means the closer the participant feels their knee is back to normal function.
Knee Injury Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week. Minimum Score: None Maximum Score: Extreme On a per question basis, the participant states how significant their knee symptoms are.
Knee Injury Osteoarthritis Outcome Score (KOOS)
Time frame: 3-week follow-up
Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week. Minimum Score: None Maximum Score: Extreme On a per question basis, the participant states how significant their knee symptoms are.
Knee Injury Osteoarthritis Outcome Score (KOOS)
Time frame: 6-week follow-up
Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week. Minimum Score: None Maximum Score: Extreme On a per question basis, the participant states how significant their knee symptoms are.
The Veterans Rand 12 Item Health Survey (VR-12)
Time frame: Baseline
The Veterans Rand 12 Item Health Survey (VR-12) asks participants about their feelings and how well they can do their usual activities. Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health. Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them. Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities. Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work. Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted. Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.
The Veterans Rand 12 Item Health Survey (VR-12)
Time frame: 3-week follow-up
The Veterans Rand 12 Item Health Survey (VR-12) will ask participants about how they feel and how well they are able to do their usual activities. Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health. Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them. Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities. Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work. Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted. Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.
The Veterans Rand 12 Item Health Survey (VR-12)
Time frame: 6-week follow-up
The Veterans Rand 12 Item Health Survey (VR-12) will ask participants about how they feel and how well they are able to do their usual activities. Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health. Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them. Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities. Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work. Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted. Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.
Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 &5
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \&5.
Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 \& 9.
Biorepository Blood Draw for Biomarkers of Interest TGF-B
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.
Biorepository Blood Draw for Biomarkers of Interest Aggrecan
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Biorepository Blood Draw for Biomarkers of Interest HYAL2
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Biorepository Blood Draw for Biomarkers of Interest CRP
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Biorepository Blood Draw for Biomarkers of Interest HA
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Biorepository Blood Draw for Biomarkers of Interest CD14
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Biorepository Blood Draw for Biomarkers of Interest CD16
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Biorepository Blood Draw for Biomarkers of Interest CD64
Time frame: Baseline
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Knee Joint Aspiration for Biomarkers of Interest CD64
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Knee Joint Aspiration for Biomarkers of Interest CD16
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Knee Joint Aspiration for Biomarkers of Interest CD14
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Knee Joint Aspiration for Biomarkers of Interest HA
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Knee Joint Aspiration for Biomarkers of Interest CRP
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Knee Joint Aspiration for Biomarkers of Interest HYAL2
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Knee Joint Aspiration for Biomarkers of Interest Aggrecan
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Knee Joint Aspiration for Biomarkers of Interest TGF-B
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7\& 9.
Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5
Time frame: Baseline
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \& 5.
Biorepository Blood Draw for Biomarkers of Interest CD64.
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Biorepository Blood Draw for Biomarkers of Interest CD16
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Biorepository Blood Draw for Biomarkers of Interest CD14
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Biorepository Blood Draw for Biomarkers of Interest HA
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Biorepository Blood Draw for Biomarkers of Interest CRP
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Biorepository Blood Draw for Biomarkers of Interest HYAL2
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Biorepository Blood Draw for Biomarkers of Interest Aggrecan
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Biorepository Blood Draw for Biomarkers of Interest TGF-B
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.
Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 \& 9.
Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 & 5
Time frame: 6-week follow-up
4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \& 5.
Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 \& 5.
Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 \& 9.
Knee Joint Aspiration for Biomarkers of Interest TGF-B
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.
Knee Joint Aspiration for Biomarkers of Interest Aggrecan
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.
Knee Joint Aspiration for Biomarkers of Interest HYAL2
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.
Knee Joint Aspiration for Biomarkers of Interest CRP
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.
Knee Joint Aspiration for Biomarkers of Interest HA
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.
Knee Joint Aspiration for Biomarkers of Interest CD14
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.
Knee Joint Aspiration for Biomarkers of Interest CD16
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.
Knee Joint Aspiration for Biomarkers of Interest CD64
Time frame: 6-week follow-up
Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.
Complete Blood Count (CBC) Analysis WBC
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of WBC.
Complete Blood Count (CBC) Analysis RBC
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of RBC.
Complete Blood Count (CBC) Analysis HGB
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of HGB.
Complete Blood Count (CBC) Analysis HCT
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of HCT.
Complete Blood Count (CBC) Analysis PLT
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of PLT.
Complete Blood Count (CBC) Analysis LYM%
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM%.
Complete Blood Count (CBC) Analysis LYM#
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM#.
Complete Blood Count (CBC) Analysis MON%
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of MON%.
Complete Blood Count (CBC) Analysis GRA%
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of GRA%.
Complete Blood Count (CBC) Analysis Neutrophil%
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of Neutrophil%.
Complete Blood Count (CBC) Analysis Eosinophil%,
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of Eosinophil%.
Complete Blood Count (CBC) Analysis Basophil%
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of Basophil%.
Complete Blood Count (CBC) Analysis MON#
Time frame: Baseline
Whole blood and PRP spin analysis will be completed to analyze total blood content of MON#.
Results and safety
The study was stopped early (reason given: The Institutional Review Board terminated the protocol on 10 October 2024.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 24212364Arnoczky SP, Sheibani-Rad S. The basic science of platelet-rich plasma (PRP): what clinicians need to know. Sports Med Arthrosc Rev. 2013 Dec;21(4):180-5. doi: 10.1097/JSA.0b013e3182999712.
- Background: PubMed 26254236Assis L, Milares LP, Almeida T, Tim C, Magri A, Fernandes KR, Medalha C, Renno AC. Aerobic exercise training and low-level laser therapy modulate inflammatory response and degenerative process in an experimental model of knee osteoarthritis in rats. Osteoarthritis Cartilage. 2016 Jan;24(1):169-77. doi: 10.1016/j.joca.2015.07.020. Epub 2015 Aug 5.
- Background: PubMed 3597586Blank ML, Cress EA, Snyder F. Separation and quantitation of phospholipid subclasses as their diradylglycerobenzoate derivatives by normal-phase high-performance liquid chromatography. J Chromatogr. 1987 Apr 17;392:421-5. doi: 10.1016/s0021-9673(01)94286-4. No abstract available.
- Background: PubMed 30350299Cook CS, Smith PA. Clinical Update: Why PRP Should Be Your First Choice for Injection Therapy in Treating Osteoarthritis of the Knee. Curr Rev Musculoskelet Med. 2018 Dec;11(4):583-592. doi: 10.1007/s12178-018-9524-x.
- Background: PubMed 28322719Dhillon MS, Patel S, John R. PRP in OA knee - update, current confusions and future options. SICOT J. 2017;3:27. doi: 10.1051/sicotj/2017004. Epub 2017 Mar 22.
- Background: PubMed 32503238Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.
- Background: PubMed 32551947Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.
- Background: PubMed 35155145Goncalves AB, Bovo JL, Gomes BS, Pigoso AA, Felonato M, Esquisatto MAM, Filho GJL, do Bomfim FRC. Photobiomodulation (lambda=808nm) and Platelet-Rich Plasma (PRP) for the Treatment of Acute Rheumatoid Arthritis in Wistar Rats. J Lasers Med Sci. 2021 Oct 18;12:e60. doi: 10.34172/jlms.2021.60. eCollection 2021.
- BackgroundHamblin M, Demidova-Rice TN. Cellular chromophores and signaling in low level light therapy. In Biomedical Optics 2007
- Background: PubMed 29939661Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/
- Background: PubMed 29599843Huang G, Hua S, Yang T, Ma J, Yu W, Chen X. Platelet-rich plasma shows beneficial effects for patients with knee osteoarthritis by suppressing inflammatory factors. Exp Ther Med. 2018 Mar;15(3):3096-3102. doi: 10.3892/etm.2018.5794. Epub 2018 Jan 24.
- Background: PubMed 26420240Ip D. Does addition of low-level laser therapy (LLLT) in conservative care of knee arthritis successfully postpone the need for joint replacement? Lasers Med Sci. 2015 Dec;30(9):2335-9. doi: 10.1007/s10103-015-1814-6. Epub 2015 Sep 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott P Grogan principal investigator
Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy, Platelet-Rich Plasma Injection and Photobiomodulation Therapy in people with Knee Osteoarthritis, run by Musculoskeletal Injury Rehabilitation Research for Operational Readiness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Institutional Review Board terminated the protocol on 10 October 2024.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kellgren Lawrence Classification System (KL) (time frame: Baseline). The study lists 64 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122116, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.