Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
83
Locations
2
Results
Posted
Publications
1
Study 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 studies. This proposal will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals relative to placebo (P) evaluating its effects on pain and function in aging and testing potential underlying neurobiological mechanisms.
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 pain being the primary symptom, negatively impacting physical, cognitive, and emotional functioning. Symptomatic knee osteoarthritis has been traditionally attributed to peripheral mechanisms, but measures of joint damage only modestly account for the presence or severity of osteoarthritis-related pain. The neuropeptide oxytocin has been recognized as a mediator of endogenous analgesia in animal and human studies. However, little is known about the neurobiological mechanisms underlying oxytocin's pain-relieving properties. This study will test the efficacy and safety of self-administered intranasal oxytocin over 4-weeks in older individuals with knee osteoarthritis. Relative to placebo, daily administration of intranasal oxytocin diminished self-reported pain, physical and emotional functioning and changes in brain metabolite concentrations. With strong support from the University of Florida and the McKnight Brain Institute, this interdisciplinary project, using a comprehensive multi-methods approach, will be the first to determine the potential benefit of oxytocin as a novel analgesic therapy for knee osteoarthritis pain in aging.
Interventions
DRUG
During the 4 week intervention, participants will self-administer twice daily 24 International Units intranasal oxytocin (OT) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.
DRUG
During the 4 week intervention, participants will self-administer twice daily 24 International Units intranasal placebo (P) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.
Timeline
First posted
Mar 18, 2019
Study start
Aug 6, 2019
Primary completion
Dec 19, 2024
Study completion
Dec 19, 2024
Results posted
Feb 23, 2026
Registry updated
Feb 23, 2026
Outcomes
Change in WOMAC Pain (0-20 Scale)
Time frame · Baseline -> Week 4
The WOMAC Pain subscale measures self-reported knee pain severity during daily activities. The subscale consists of 5 items assessing pain during walking, stair climbing, nocturnal pain, pain at rest, and weight-bearing activities. Each item is scored 0-4 (0=none, 4=extreme), yielding a total Pain subscale score of 0-20. Higher scores indicate greater pain severity. Change scores were calculated as post-treatment minus baseline; negative values indicate improvement (reduced pain).
Not reported in the indexed record.
Eligibility
Inclusion Criteria: * 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 Criteria: * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Department of Community Dentistry and Behavioral Science
Gainesville, Florida, United States
UF Health of University of Florida
Gainesville, Florida, United States
Publications
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