Status:
COMPLETED
Understanding Cognition, Oxytocin & Pain in Elders
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Knee Osteoarthritis
Osteoarthritis
Eligibility:
All Genders
45-100 years
Phase:
PHASE2
PHASE3
Brief Summary
Osteoarthritis (OA) represents a significant cause of disability worldwide and the knee is the most commonly affected joint. Oxytocin (OT) is a mediator of endogenous analgesia in animal and human stu...
Detailed Description
Osteoarthritis represents a significant cause of disability worldwide in individuals aged 65 and older, a rapidly growing segment of our population. The knee is the most commonly affected joint with p...
Eligibility Criteria
Inclusion
- knee osteoarthritis/or back pain of at least six months duration, experience pain on more days than not, with moderate pain at baseline (i.e., \> 3/6 in the Visual Descriptor Scale), and who have elevated levels of plasma Imterleukin-6 (\>2.5 pg/ml) will be considered for participation.
Exclusion
- Hypersensitivity to OT or vasopressin,
- history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia,
- on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication,
- low sodium and high osmolality levels,
- excessive smoking,
- excessive drinking,
- muscle pain as a result of systemic disease,
- significant nasal pathology,
- previous or concurrent use of narcotics delivered intranasally (e.g., cocaine),
- gastroparesis.
- individuals with heart problems (e.g., cardiomyopathy, history of myocardial infarction, arrhythmias, prolonged QT interval)
- Participants will also be excluded if they have concurrent medical or arthritic conditions that could confound symptomatic knee osteoarthritis-related outcomes or coexisting disease that could preclude successful completion of the protocol including:
- systemic rheumatic condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia);
- a history of clinically significant surgery to the index knee;
- uncontrolled hypertension (\>150/95);
- poorly controlled diabetes (HbA1c\>7%);
- neurological disease (e.g., Parkinson's, Multiple Sclerosis);
- cardiovascular or peripheral arterial disease;
- serious psychiatric disorder requiring hospitalization within the past twelve months or characterized by active suicidal ideation;
- diminished cognitive function that would interfere with completion of study procedures (i.e., Montreal Cognitive Assessment score \< 25)\]; and
- large pieces of metal in the body or metal in the face or neck,
- claustrophobia,
- major medical surgery in the past two months,
- history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures\].
- pregnant individuals will be excluded
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03878589
Start Date
August 6 2019
End Date
December 19 2024
Last Update
March 13 2025
Active Locations (2)
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1
Department of Community Dentistry and Behavioral Science
Gainesville, Florida, United States, 32603
2
UF Health of University of Florida
Gainesville, Florida, United States, 32610