Status:
COMPLETED
Mechanisms of Palmitoylethanolamide (PEA) to Alter Pain Sensitivity in Knee Osteoarthritis
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purposes of this 1-year proof of feasibility and acceptability pilot study are twofold. First to determine if participants with knee osteoarthritis (KOA) will comply with taking palmitoylethanolam...
Detailed Description
Knee osteoarthritis (KOA) affects nearly 30% of adults aged 60 years or older and causes significant pain and disability.1 Neurophysiological testing (quantitative sensory testing (QST)) demonstrates ...
Eligibility Criteria
Inclusion
- Adults aged 40 to 80
- English speaking
- Self reported diagnosis of osteoarthritis in one or both knees
- Self-reported average knee pain over the past month at least 4 out of 10 on a 0-10 numeric rating scale
- Agreement to abstain from all osteoarthritis pain medication (such as non-steroidal anti-inflammatory drugs or narcotics) and use only acetaminophen as a rescue medication when needed
- Can pass an evaluation to sign consent
Exclusion
- Inflammatory arthritis (eg. Rheumatoid arthritis)
- Knee injury in past 6 months
- Knee surgery in past 12 months or total knee replacement
- Pregnant or breastfeeding
- enrolled in other knee OA rehabilitation programs or clinical trials
- Any of the following conditions: chronic kidney disease stage 3-5, unstable angina, congestive heart failure, cancer or cancer treatment (except skin)
- Oral or intra-articular glucocorticoid use in the prior 3 months; intra-articular hyaluronate use in the prior 6 months
- Opioid use in the past month
- Allergy to oat, coconut, citrus, olive, or sunflower oils, or maltodextrin
Key Trial Info
Start Date :
March 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05406726
Start Date
March 22 2023
End Date
January 2 2024
Last Update
November 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201