None listed
Conditions
Brief summary
This is a two-arm, double-blind, randomised, placebo-controlled, parallel-group, superiority trial investigating the immediate effects of a non-steroidal anti-inflammatory drug (single 400 mg oral dose of ibuprofen) compared to placebo on knee pain, patellofemoral joint force and clinical outcomes during running in individuals with patellofemoral pain. Participants will complete pre- and post-intervention biomechanical assessments in a single laboratory session.
Interventions
Arm 1 (Ibuprofen):
Participants allocated to the ibuprofen group will receive a single oral dose of ibuprofen 400 mg. This dose is consistent with the recommended adult dose and is below the maximum non-prescription daily dose of 1200 mg. The ibuprofen formulation is classified as a non-prescription medicine in Australia. Immediately after completing the baseline assessments, participants will ingest one 400 mg tablet orally with water under the direct observation of a member of the research tea
Arm 1 (Ibuprofen): Participants allocated to the ibuprofen group will receive a single oral dose of ibuprofen 400 mg. This dose is consistent with the recommended adult dose and is below the maximum non-prescription daily dose of 1200 mg. The ibuprofen formulation is classified as a non-prescription medicine in Australia. Immediately after completing the baseline assessments, participants will ingest one 400 mg tablet orally with water under the direct observation of a member of the research team. Before receiving the intervention, participants will complete a baseline running assessment. They will first perform a 5-minute treadmill warm-up at 3.0–3.5 m/s. This will be followed by two familiarisation runs and eight acceptable 40-metre overground running trials while wearing standardised neutral running shoes. Participants will run at 3.0-3.5 m/s, with speed measured using timing gates positioned around the force plates. A trial will be considered acceptable when the participant runs within the prescribed speed range and both feet make clean contact with the embedded force plates. Participants will walk back to the starting position between trials, with additional rest and water provided as needed. Perceived exertion will be measured after the complete set of running trials using the 6–20 Borg Rating of Perceived Exertion scale. The ibuprofen dose will be administered immediately after completion of the baseline running assessment and associated post-running measures. Participants will then rest quietly for approximately 35 minutes to allow for drug absorption. After this period, they will repeat the 5-minute treadmill warm-up at 3.0–3.5 m/s, followed by the same static calibration, two familiarisation runs and eight acceptable overground running trials at 3.0–3.5 m/s. Perceived exertion will again be measured using the Borg scale after completion of the post-dose running trials.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
- Insidious onset of anterior or peripatellar knee pain, with a duration of at least 2 months. - Worst pain intensity equal or greater than 30 on a 0-100 numerical rating scale during the previous month. - Pain around or behind the patella during at least two of the following activities: sitting for a prolonged period, rising from sitting, squatting, kneeling, running, walking up stairs, walking down stairs, jumping, landing, heavy household activities and after sports and recreational activities. - Individuals who have maintained an average running volume of at least 5 km per week during the past 2 months. - Individuals must be able to understand and speak English.
Exclusion criteria
- Known allergy or hypersensitivity to ibuprofen or history of adverse ibuprofen reactions. - Known hypersensitivity to aspirin and other NSAIDs. - Asthma that is aspirin or NSAID-sensitive. - Active gastrointestinal bleeding or peptic ulceration. - Renal, hepatic or any known cardiac impairment. - Use of medicines known to interact with Ibuprofen, including current use of other NSAIDs or salicylates, anticoagulants (e.g., warfarin), lithium, methotrexate, antihypertensive agents (angiotensin-converting enzyme inhibitors, beta-blockers, diuretics), oral corticosteroids (e.g., prednisone, prednisolone, cortisone), zidovudine, medicines used to treat diabetes. - Failure to meet pre-defined washout periods: no NSAIDs or aspirin in the 72 hours before testing, no oral corticosteroids in the 7 days before testing, no weekly methotrexate in the 7 days before testing. - Recent use of other analgesics, anti-inflammatory, or psychoactive medications within 3 days of testing (to avoid confounding effects or drug interactions). - History of knee surgery. - History of patellar dislocation. - Clinical evidence of meniscal injury or ligamentous instability. - Self-reported current or recent hip, ankle, or foot pain (>30 on a 0-100 point NRS). - Use of any knee injection (e.g., PRP, hyaluronic acid, cortiscosteroid) in the previous 6 months - Pregnant.
Outcome results
None listed