Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis

Launched by NORTHWESTERN UNIVERSITY · Jun 18, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how effective nonsteroidal anti-inflammatory drugs (NSAIDs) are for people who suffer from painful knee osteoarthritis (OA). The study is designed for adults over 40 years old who experience moderate pain in their knees and are willing to stop their current OA pain medications. Participants will need to keep track of their pain using a daily diary and can expect to try different NSAIDs during the study to see which one works best for them.

To take part in the trial, you must be able to provide consent and have knee pain that’s at least a level 4 out of 10. You should also be able to use a cellphone or computer for tracking your pain. However, certain health conditions, like a history of stomach bleeding or heart issues, may prevent you from joining. If you qualify and decide to participate, you'll help researchers learn more about managing knee pain, which could improve treatment options for many people in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female \>40 years of age
• • 2. Meet ACR criteria for knee OA
• • 3. Able and willing to provide informed consent
• • 4. Average weekly pain in the index knee based on daily pain assessments of ≥ 4/10 and \<9/10 on an 11-point NRS scale
• • 5. Willing to discontinue current medications taken for OA pain
• • 6. For women of child-bearing potential, willing to utilize some form of birth control or abstinence during the course of the study
• • 7. If taking cannabinoids, have to be on a stable dose and have this maintained for the duration of the study
• • 8. If receiving physical therapy or any non-pharmacologic modality(ies) for OA, these need to continue and remain stable for the duration of the study
• • 9. Ambulatory
• • 10. Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed
• • 11. Use of medications for knee OA pain on at least 4 out of 7 days per week
• • 12. eDiary entries on at least 4 out 7 days per week during the observation period
• • 13. Sub-Group Criterion (≥12 participants): Variability of average daily pain in the index knee during the observation period of ≥ 2 points on the NRS scale on at least 4 occasions
• Exclusion criteria:
• • 1. History of intolerance or allergic reaction to NSAIDs
• • 2. Previous history of GI bleed
• • 3. Renal insufficiency resulting in serum creatinine \> 1.5 mg/dL
• • 4. History of myocardial infarction in last 6 months
• • 5. Coexisting congestive heart failure or symptomatic atherosclerotic heart disease
• • 6. Use of oral anticoagulants other than aspirin ≤ 325 mg for cardiac prophylaxis
• • 7. Use of heparin or injectable anticoagulant
• • 8. Uncontrolled hypertension
• • 9. Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study
• • 10. Use of recreational drugs
• • 11. Fibromyalgia
• • 12. Inflammatory arthropathies of any sort
• • 13. Chronic back pain in which pain level is greater than the OA pain
• • 14. Participation in another clinical trial other than one for covid or an observational and non-interventional study
• • 15. Use of walker or other aid for walking other than a single cane
• • 16. Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint
• • 17. Index knee cannot have had previous joint replacement surgery
• • 18. Arthroscopy within the past 6 months
• • 19. Injection of hyaluronate in the index knee in the past 6 months
• • 20. Corticosteroid injection in the index knee in the past 3 months
• • 21. Injection of any biologic agent in the index in the past 12 months
• • 22. Nerve ablation for the treatment of pain in the index knee
• • 23. Any acute or chronic pain condition which would interfere with the evaluation of knee pain.
• • 24. Pregnant, nursing or planning to become pregnant during length of study