N of 1 Pilot Study of NSAID in People With Painful Knee OA
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Once screened and found eligible, participants will be entered into an initial blinded 2-week treatment period of either naproxen or placebo and then entered into an open washout period of 2 weeks. At the end of this washout, participants will then receive either naproxen or placebo for a further 2 week period followed again by a 2 week washout. This sequence will then be repeated (total of 4 treatment periods) such that all participants recieve naproxen for 2 treatment periods and placebo for 2 treatment periods. The order of treatment will be randomized.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cross-over Treatment: Initial treatment with naproxen There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded. |
Drug: Naproxen 500 Mg
naproxen tablets
Other Names:
Drug: Placebo
lactose NF
|
| Experimental: Cross-over Treatment: Initial treatment with placebo There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded. |
Drug: Naproxen 500 Mg
naproxen tablets
Other Names:
Drug: Placebo
lactose NF
|
Outcome Measures
Primary Outcome Measures
- mean of one week's daily pain ratings on an NRS scale [baseline to end of 14 day treatment period]
daily pain will be collected by a web application and averaged over a 7day period
Other Outcome Measures
- KOOS [baseline to end of 14 day treatment period]
KOOS questionnaire
- PDQ [baseline to end of 14 day treatment period]
Pain detect questionnaire
- PANAS questionnaire [baseline to end of 14 day treatment period]
positive and negative affect
- QST [baseline to end of 14 day treatment period]
quantitative sensory testing parameters - temporal summation
- ODI [baseline to end of 14 day treatment period]
Oswestry Disability Index
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female >40 years of age
-
Meet ACR criteria for knee OA
-
Able and willing to provide informed consent
-
Average weekly pain in the index knee based on daily pain assessments of ≥ 4/10 and <9/10 on an 11-point NRS scale
-
Willing to discontinue current medications taken for OA pain
-
For women of child-bearing potential, willing to utilize some form of birth control or abstinence during the course of the study
-
If taking cannabinoids, have to be on a stable dose and have this maintained for the duration of the study
-
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
-
Ambulatory
-
Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed
Exclusion criteria:
-
History of intolerance or allergic reaction to NSAIDs
-
Previous history of GI bleed
-
Renal insufficiency resulting in serum creatinine > 1.5 mg/dL
-
History of myocardial infarction in last 6 months
-
Coexisting congestive heart failure or symptomatic atherosclerotic heart disease
-
Use of oral anticoagulants other than aspirin ≤ 325 mg for cardiac prophylaxis
-
Use of heparin or injectable anticoagulant
-
Uncontrolled hypertension
-
Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study
-
Use of recreational drugs
-
Fibromyalgia
-
Inflammatory arthropathies of any sort
-
Chronic back pain in which pain level is greater than the OA pain
-
Participation in another clinical trial other than one for covid or an observational and non-interventional study
-
Use of walker or other aid for walking other than a single cane
-
Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint
-
Index knee cannot have had previous joint replacement surgery
-
Arthroscopy within the past 6 months
-
Injection of hyaluronate in the index knee in the past 6 months
-
Corticosteroid injection in the index knee in the past 3 months
-
Injection of any biologic agent in the index in the past 12 months
-
Nerve ablation for the treatment of pain in the index knee
-
Any acute or chronic pain condition which would interfere with the evaluation of knee pain.
-
Pregnant, nursing or planning to become pregnant during length of study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00215311