N of 1 Pilot Study of NSAID in People With Painful Knee OA

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study with a 4-period double-cross-over design evaluating a treatment with non-steroidal anti-inflammatory drugs (NSAIDs) in people with painful knee osteoarthritis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Naproxen

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

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