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Ibuprofen and PRP for Osteoarthritis (PRPNSAIDsKOA Trial)

Phase 1 & 2

Recruiting

Led By Kenneth P Barnes, MD, MSc.

Research Sponsored by QC Kinetix LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.

Awards & highlights

PRPNSAIDsKOA Trial Summary

This trial aims to see if a combination of drug therapy and Platelet-Rich Plasma injections can reduce knee pain and improve physical function in individuals with osteoarthritic knee joints. Participants will be randomly

Who is the study for?

This trial is for individuals over 50 with knee osteoarthritis, confirmed by X-rays, who have had knee pain most days in the past month. Participants must be able to attend 8 visits over a year and understand English. Those with symptoms in both knees or unable to commit to the study schedule are excluded.Check my eligibility

What is being tested?

The study tests if combining Platelet-Rich Plasma (PRP) injections with one of three blinded medications—Acetaminophen, Ibuprofen, or a placebo—reduces pain and improves function in an arthritic knee. Pain and functionality will be measured through questionnaires during office visits across a year.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site from PRP such as pain or swelling, gastrointestinal issues from NSAIDs like Ibuprofen, and liver-related effects from Acetaminophen use.

PRPNSAIDsKOA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.

This trial's timeline: 3 weeks for screening, Varies for treatment, and scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IKDC pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.

KOOS pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.

VAS pain scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.

+1 more

PRPNSAIDsKOA Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Ibuprofen and PRPActive Control1 Intervention

Weight based Ibuprofen provided in over-encapsulated blister pack (to ensure blinding), to be taken 3 times a day for the initial 6 months of the 12 month study period. PRP injections provided at month 1, 2, and 3.

Group II: Acetaminophen and PRPActive Control1 Intervention

Weight based Acetaminophen provided in over-encapsulated blister pack (to ensure blinding), to be taken 3 times a day for the initial 6 months of the 12 month study period. PRP injections provided at month 1, 2, and 3.

Group III: Placebo and PRPPlacebo Group1 Intervention

Placebo provided in over-encapsulated blister pack (to ensure blinding), to be taken 3 times a day for the initial 6 months of the 12 month study period. PRP injections provided at month 1, 2, and 3.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

QC Kinetix LLCLead Sponsor

Kenneth P Barnes, MD, MSc.Principal InvestigatorQC Kinetix LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals in total are enrolled as participants in this medical study?

"Indeed, as per the details on clinicaltrials.gov, this clinical trial is actively enrolling participants. The trial was first listed on 11/1/2023 and last modified on 4/1/2024. The recruitment goal is to enroll 300 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis

2023. "Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05742763.

All > Osteoarthritis > Knee Osteoarthritis