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.
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
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
Parallel
Leukocyte-Rich Platelet-Rich Plasma
Biological/VaccineA 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
DrugIbuprofen 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
DrugAcetaminophen 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.
Change From Baseline in Knee Pain Measured by a Visual Analog Scale
Knee pain will be measured using a 100-mm visual analog scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Change from baseline will be calculated, with a negative change indicating improvement.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Total Score
The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire includes 24 items assessing pain, stiffness, and physical function. Each item is scored from 0 to 4, resulting in a total score from 0 to 96. Higher scores indicate worse symptoms and greater functional limitation. Change from baseline will be calculated.
Additional Analgesic Consumption
The number of additional analgesic doses used after the intervention will be recorded using a standardized participant form. Higher values indicate greater use of rescue analgesic medication.
Incidence and Severity of Adverse Events
The number of participants experiencing adverse events will be recorded. Events will be classified according to the Common Terminology Criteria for Adverse Events, version 5.0, from grade 1 (mild) to grade 5 (death).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
