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

Sponsor
Federal University of São Paulo
Study ID
NCT07766330
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Leukocyte-Rich Platelet-Rich Plasma — BIOLOGICAL
    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.
  • ibuprofen — DRUG
    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.
  • Acetaminophen — DRUG
    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.

Study Details

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 Dates

First listed
Aug 14, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Platelet-Rich Plasma Plus Ibuprofen
    Participants will receive a single ultrasound-guided intra-articular injection of leukocyte-rich platelet-rich plasma, followed by ibuprofen 400 mg orally every eight hours for five consecutive days.
  • Active Comparator: Platelet-Rich Plasma Plus Acetaminophen
    Participants will receive a single ultrasound-guided intra-articular injection of leukocyte-rich platelet-rich plasma, followed by acetaminophen 500 mg orally every eight hours for five consecutive days.

Primary Outcome Measure

Change From Baseline in Knee Pain Measured by a Visual Analog Scale [ Time Frame: Baseline and 6 months after the intervention ]

Central Contacts

Related Studies