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Effect of Nonsteroidal Anti-Inflammatory Drug Restriction on the Efficacy of Platelet-Rich Plasma in Knee Osteoarthritis

NCT07766330 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-14

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to learn whether taking ibuprofen, a nonsteroidal anti-inflammatory drug, after a platelet-rich plasma (PRP) injection changes pain relief and knee function in adults with knee osteoarthritis.

The main questions it aims to answer are:

Does ibuprofen change the improvement in knee pain six months after a PRP injection compared with acetaminophen?

Does ibuprofen change knee function or the need for additional pain medicine during follow-up?

Researchers will compare PRP followed by ibuprofen with PRP followed by acetaminophen. Participants will receive one ultrasound-guided PRP injection and take the assigned medication every eight hours for five days. They will complete assessments of pain, knee function, additional pain medicine use, and safety. Participants and the physician performing the injection will not know which medication was assigned.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Leukocyte-Rich Platelet-Rich Plasma

A single 12 mL intra-articular injection of autologous leukocyte-rich platelet-rich plasma, prepared from 54 mL of peripheral venous blood using a standardized single-centrifugation protocol without anticoagulants or exogenous activators. The injection will be performed using a lateral suprapatellar approach under ultrasound guidance.

DRUG

ibuprofen

Ibuprofen 400 mg oral capsules administered every eight hours for five consecutive days, starting immediately after the platelet-rich plasma injection. Capsules will be visually identical to the acetaminophen capsules.

DRUG

Acetaminophen

Acetaminophen 500 mg oral capsules administered every eight hours for five consecutive days, starting immediately after the platelet-rich plasma injection. Capsules will be visually identical to the ibuprofen capsules.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-06-30
Completion
2028-10-31

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766330 on ClinicalTrials.gov