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

NCT07766330 | Not Yet Recruiting

• 1 other identifier: 99121626.1.0000.5505
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

Platelet-Rich Plasma; Nonsteroidal Anti-Inflammatory Drugs; Intra-Articular Injection; Knee Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months after the intervention

Secondary Outcomes (2)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Total Score

  Baseline and 3, 6, and 12 months after the intervention

• Additional Analgesic Consumption

  1 week, 3 weeks and 3 months after the intervention

Other Outcomes (1)

• Incidence and Severity of Adverse Events

  24 hours, 48 hours, 7 days, and through 12 months after the intervention

Study Arms (2)

Platelet-Rich Plasma Plus Ibuprofen

EXPERIMENTAL

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.

Biological: Leukocyte-Rich Platelet-Rich Plasma; Drug: ibuprofen

Platelet-Rich Plasma Plus Acetaminophen

ACTIVE COMPARATOR

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.

Biological: Leukocyte-Rich Platelet-Rich Plasma; Drug: Acetaminophen

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.

Also known as: LR-PRP, Platelet-Rich Plasma, PRP

Platelet-Rich Plasma Plus Acetaminophen; Platelet-Rich Plasma Plus Ibuprofen

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.

Platelet-Rich Plasma Plus Ibuprofen

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.

Also known as: Paracetamol

Platelet-Rich Plasma Plus Acetaminophen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Disciplina de Medicina Esportiva da UNIFESP

São Paulo, São Paulo, 04022-002, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Guilherme Moury Fernandes, MD

CONTACT

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

Monique Ribas Scherer, MD

CONTACT

+55 11 3385-4343; monique.scherer@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Ibuprofen and acetaminophen will be provided in visually identical capsules. Participants and the physician performing the platelet-rich plasma injection will remain blinded to the assigned medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Professor, Department of Orthopaedics and Traumatology

Model Details: Two-arm, parallel-group trial with 1:1 random allocation. Both groups will receive a single platelet-rich plasma injection and will differ only in the post-procedure medication assigned for five days: ibuprofen or acetaminophen.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)