Status:
COMPLETED
Biomarkers for Prediction of Analgesic Efficacy in Knee OA.
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Knee, Osteoarthritis (OA)
Biomarkers for Prediction of OA Treatment Efficacy
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
With high NNTs for indiscriminative use in chronic pain, treatment unavoidably entails frustrating long trial and errors. It is timely to identify biomarkers that can predict analgesic efficacy for th...
Detailed Description
Study design: The study design includes two experimental meeting sessions (before and at the end / after the treatment) which include clinical and experimental assessments. After the first experiment...
Eligibility Criteria
Inclusion
- males and females
- ages 45 to 75
- radiographic representation of osteoarthritis of the knee
- minimal or moderate OA severity, based on the Kellgren and Lawrence system classification (1-3)
- knee OA pain for more than 3 months, assessed by the patients as being at level 4/10 and above on average at routine daily standing/walking activities during the last week, without medication
Exclusion
- other more prominent pain
- previous bilateral total knee replacement (TKR) surgery
- secondary OA (post-traumatic or post-infectious, osteochondritis dissecans (OCD) and enteropathic arthritis (EA) deformity)
- significant additional health problems such as substantial painful neuropathy, diabetes above of 5 yrs, renal failure, congestive heart failure, neurological diseases that might mask the pain processing system or reduce patient's cooperation or report capabilities, and significant psychiatric disorders
- use of opioids or cannabis
- known diseases of gastrointestinal tract such as esophagitis, gastritis and duodenitis
- patients that had side effects to the study drugs in the past.
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05256342
Start Date
December 30 2021
End Date
April 8 2024
Last Update
April 12 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rambam Health Care Campus
Haifa, Israel, 31096
2
Rambam Health Care Campus
Haifa, Israel