Not Yet RecruitingNot Applicable

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

Brazil90 participantsStarted 2026-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Hemoglobin below 11 g/dL * Hematocrit below 33% * Platelet count below 150,000/mm3 * Advanced knee osteoarthritis * Rheumatologic disease * Chronic kidney disease * Respiratory disease, including rhinitis, asthma, or chronic obstructive pulmonary disease * Active or previous oncologic disease, as defined in the protocol * Fibromyalgia * Psychiatric disorder currently under treatment * Substance dependence, including smoking, harmful alcohol use, or other substance use * Use of nonsteroidal anti-inflammatory drugs within the previous 30 days * Use of systemic, intra-articular, topical, or inhaled glucocorticoids within the previous 3 months * Current use of anticoagulant or antiplatelet medication * American Society of Anesthesiologists physical status classification of 3 or higher * Currently receiving disability or sickness-related social security benefits * Inability or unwillingness to provide informed consent or complete the required patient-reported outcome measures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Knee Pain Measured by a Visual Analog Scale

Timeframe: Baseline and 6 months after the intervention

Trial details

NCT IDNCT07766330

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Guilherme Moury Fernandes, MD

+55 11 3385-4343 guilherme.moury@unifesp.br

View on ClinicalTrials.gov More Osteoarthritis, Knee trials