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NOT YET RECRUITING
NCT07766330
NA

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

Sponsor: Federal University of São Paulo

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-10-01

Completion Date

2028-10

Last Updated

2026-08-14

Healthy Volunteers

No

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.

Locations (1)

Disciplina de Medicina Esportiva da UNIFESP

São Paulo, São Paulo, Brazil