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PRP + Photobiomodulation for Knee Osteoarthritis

N/A

Waitlist Available

Led By Scott P Grogan

Research Sponsored by Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Knee Osteoarthritis

Between 18-64 years old

Must not have

Tattoo in treatment area

Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial examines how combining a therapy technique and a medicine injection can help with knee osteoarthritis treatment and improve pain and functionality.

Who is the study for?

Eligible participants are between 18-64 years old, diagnosed with Knee Osteoarthritis, and must meet certain criteria like being over 50 or having morning stiffness. They should be fluent in English and able to commit to the study. Exclusions include recent surgeries, other knee treatments, lower extremity injuries, or conditions that could affect pain perception.

What is being tested?

The trial is testing how well different combinations of Physical Therapy (PT), Platelet-Rich Plasma Injection (PRP), and Photobiomodulation Therapy (PBMT) work for treating Knee Osteoarthritis. It looks at pain relief and joint function by comparing PT alone versus PT combined with PRP or PBMT or both.

What are the potential side effects?

Potential side effects from PRP injections may include temporary increased pain at the injection site, bleeding, tissue damage, infection risk; while PBMT might cause mild skin irritation. Side effects vary based on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with knee osteoarthritis.

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I am between 18 and 64 years old.

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My knee X-ray shows I have arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a tattoo in the area that needs treatment.

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I experience ongoing or recurring pain, numbness, or tingling in my lower body due to sciatica.

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I have been diagnosed with neuropathy that affects my ability to feel pain.

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I have been diagnosed with inflammatory joint disease.

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I have been diagnosed with fibromyalgia or chronic fatigue syndrome.

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I have been diagnosed with porphyria or photosensitive eczema.

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I had knee surgery within the last year.

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I have not had dry needling in the last 4 weeks.

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I am taking medication that makes me sensitive to heat or light.

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I have a history of heart disease.

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I have been diagnosed with an autoimmune disease.

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I have had memory issues, dementia, or trouble making decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 & 5

Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 &5

Biorepository Blood Draw for Biomarkers of Interest Aggrecan

+37 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: PT + Photobiomodulation Treatment (PBMT)Active Control2 Interventions

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.

Group II: PT + PRP + PBMTActive Control3 Interventions

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.

Group III: Physical Therapy (PT) OnlyActive Control1 Intervention

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.

Group IV: PT + Platelet-Rich Plasma (PRP)Active Control2 Interventions

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.

0 / 15Eligibility criteria met