Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis

NCT06122116 | Terminated DMC FDA Device

• 1 other identifier: Photomedicine Project 11
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (64)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

• Complete Blood Count (CBC) Analysis RBC

  Whole blood and PRP spin analysis will be completed to analyze total blood content of RBC.

  Baseline

• Complete Blood Count (CBC) Analysis HGB

  Whole blood and PRP spin analysis will be completed to analyze total blood content of HGB.

  Baseline

• Complete Blood Count (CBC) Analysis HCT

  Whole blood and PRP spin analysis will be completed to analyze total blood content of HCT.

  Baseline

• Complete Blood Count (CBC) Analysis PLT

  Whole blood and PRP spin analysis will be completed to analyze total blood content of PLT.

  Baseline

• Complete Blood Count (CBC) Analysis LYM%

  Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM%.

  Baseline

• Complete Blood Count (CBC) Analysis LYM#

  Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM#.

  Baseline

• Complete Blood Count (CBC) Analysis MON%

  Whole blood and PRP spin analysis will be completed to analyze total blood content of MON%.

  Baseline

• Complete Blood Count (CBC) Analysis GRA%

  Whole blood and PRP spin analysis will be completed to analyze total blood content of GRA%.

  Baseline

• Complete Blood Count (CBC) Analysis Neutrophil%

  Whole blood and PRP spin analysis will be completed to analyze total blood content of Neutrophil%.

  Baseline

• Complete Blood Count (CBC) Analysis Eosinophil%,

  Whole blood and PRP spin analysis will be completed to analyze total blood content of Eosinophil%.

  Baseline

• Complete Blood Count (CBC) Analysis Basophil%

  Whole blood and PRP spin analysis will be completed to analyze total blood content of Basophil%.

  Baseline

• Complete Blood Count (CBC) Analysis MON#

  Whole blood and PRP spin analysis will be completed to analyze total blood content of MON#.

  Baseline

Study Arms (4)

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.

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.

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.

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.

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

Interventions

Physical Therapy OTHER

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.

Also known as: SOC PT

PT + PRP + PBMT; PT + Photobiomodulation Treatment (PBMT); PT + Platelet-Rich Plasma (PRP); Physical Therapy (PT) Only

Platelet-Rich Plasma Injection BIOLOGICAL

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.

Also known as: PRP

PT + PRP + PBMT; PT + Platelet-Rich Plasma (PRP)

Photobiomodulation Therapy DEVICE

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.

Also known as: PBMT

PT + PRP + PBMT; PT + Photobiomodulation Treatment (PBMT)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DEERS Eligible
• Between 18-64 (Inclusive)
• Civilian
• Contractor
• Active Duty Service Member
• Knee Osteoarthritis diagnosis
• a) at least 3 of the following:
• \>50 years old
• Morning stiffness \< 30 minutes
• Crepitus on active movements
• Tenderness of the bony margins of the joint
• Bony enlargement
• No palpable warmth
• Fluent in speaking and reading English
• Ability to commit to study intervention and follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Musculoskeletal Injury Rehabilitation Research for Operational Readiness: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Laser Therapy; Phototherapy

Study Officials

• Scott P Grogan

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: October 13, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)