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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal University of São Paulo

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 80 years

Knee pain for at least 3 months

Radiographic evidence of knee osteoarthritis classified as Kellgren-Lawrence grade I, II, or III

Ability and willingness to provide written informed consent

Disqualifiers

Body mass index of 35 kg/m2 or higher

Pregnancy or breastfeeding

Diabetes mellitus with glycated hemoglobin greater than 6.5%

Hematologic disease, including anemia, coagulopathy, or thrombophilia

Trial design

Treatments tested in this trial

  • Leukocyte-Rich Platelet-Rich Plasma
  • ibuprofen
  • Acetaminophen

Treatment groups

90 Participants
are divided into 2 treatment groups