Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain
Abstract Background Osteoarthritis (OA) is the leading cause of disability among older adults with the knee being the most affected joint. Specifically, there is an urgent need to develop better analgesics for individuals with OA-related pain, since currently used analgesics frequently fail to provi...
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2025-02-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08715-4 |
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| author | Yenisel Cruz-Almeida Soamy Montesino-Goicolea Pedro Valdes-Hernandez Zhiguang Huo Roland Staud Natalie C. Ebner |
| author_facet | Yenisel Cruz-Almeida Soamy Montesino-Goicolea Pedro Valdes-Hernandez Zhiguang Huo Roland Staud Natalie C. Ebner |
| author_sort | Yenisel Cruz-Almeida |
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| description | Abstract Background Osteoarthritis (OA) is the leading cause of disability among older adults with the knee being the most affected joint. Specifically, there is an urgent need to develop better analgesics for individuals with OA-related pain, since currently used analgesics frequently fail to provide adequate relief or must be discontinued owing to adverse effects. A promising treatment is the neuropeptide oxytocin (OT), which has been shown to play a role in endogenous analgesia with human and animal studies demonstrating anti-nociceptive effects. The primary aims of the study are to examine preliminary analgesic effects of a chronic OT intervention in community-dwelling older individuals with chronic knee osteoarthritis pain. Methods In this article, we describe the rationale and design of the Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE) study, a double-blinded intervention in which 80 participants over 45 years of age with knee osteoarthritis pain will be recruited to participate in a cross-over trial of 4 weeks of intranasal oxytocin or placebo administration. Primary study outcomes include preliminary changes in pain intensity and interference as well as multi-modal assessment batteries including circulating biomarkers and neuroimaging measures. Self-reported and quantitative outcomes will be assessed at baseline, post-intervention periods, and up to a 6-month follow-up period. Discussion This study will establish preliminary effectiveness of a novel intervention in middle to older aged adults with knee osteoarthritis pain. Achievement of these aims will provide a rich platform for future intervention research targeting improvements in pain and disability among geriatric populations and will serve as a foundation for a fully powered trial to examine treatment efficacy and potential mechanisms of the proposed intervention. Trial registration ClinicalTrials.gov NCT03878589. Registered on March 18th, 2019. |
| format | Article |
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| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj-art-a6e706c4f6f84565a6a83b3f2b3004562025-02-09T12:53:19ZengBMCTrials1745-62152025-02-0126111610.1186/s13063-024-08715-4Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis painYenisel Cruz-Almeida0Soamy Montesino-Goicolea1Pedro Valdes-Hernandez2Zhiguang Huo3Roland Staud4Natalie C. Ebner5Department of Community Dentistry and Behavioral Science, University of FloridaDepartment of Community Dentistry and Behavioral Science, University of FloridaDepartment of Community Dentistry and Behavioral Science, University of FloridaDepartment of Biostatistics, College of Public Health & Health Professions and College of Medicine, University of FloridaPain Research and Intervention Center of Excellence, University of FloridaCenter for Cognitive Aging and Memory, McKnight Brain Institute, University of FloridaAbstract Background Osteoarthritis (OA) is the leading cause of disability among older adults with the knee being the most affected joint. Specifically, there is an urgent need to develop better analgesics for individuals with OA-related pain, since currently used analgesics frequently fail to provide adequate relief or must be discontinued owing to adverse effects. A promising treatment is the neuropeptide oxytocin (OT), which has been shown to play a role in endogenous analgesia with human and animal studies demonstrating anti-nociceptive effects. The primary aims of the study are to examine preliminary analgesic effects of a chronic OT intervention in community-dwelling older individuals with chronic knee osteoarthritis pain. Methods In this article, we describe the rationale and design of the Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE) study, a double-blinded intervention in which 80 participants over 45 years of age with knee osteoarthritis pain will be recruited to participate in a cross-over trial of 4 weeks of intranasal oxytocin or placebo administration. Primary study outcomes include preliminary changes in pain intensity and interference as well as multi-modal assessment batteries including circulating biomarkers and neuroimaging measures. Self-reported and quantitative outcomes will be assessed at baseline, post-intervention periods, and up to a 6-month follow-up period. Discussion This study will establish preliminary effectiveness of a novel intervention in middle to older aged adults with knee osteoarthritis pain. Achievement of these aims will provide a rich platform for future intervention research targeting improvements in pain and disability among geriatric populations and will serve as a foundation for a fully powered trial to examine treatment efficacy and potential mechanisms of the proposed intervention. Trial registration ClinicalTrials.gov NCT03878589. Registered on March 18th, 2019.https://doi.org/10.1186/s13063-024-08715-4AgingDisabilityKnee osteoarthritis painBrainOxytocinRandomized controlled trial |
| spellingShingle | Yenisel Cruz-Almeida Soamy Montesino-Goicolea Pedro Valdes-Hernandez Zhiguang Huo Roland Staud Natalie C. Ebner Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain Trials Aging Disability Knee osteoarthritis pain Brain Oxytocin Randomized controlled trial |
| title | Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain |
| title_full | Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain |
| title_fullStr | Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain |
| title_full_unstemmed | Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain |
| title_short | Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain |
| title_sort | understanding cognition oxytocin and pain in elders ucope protocol for a double blinded cross over trial in chronic knee osteoarthritis pain |
| topic | Aging Disability Knee osteoarthritis pain Brain Oxytocin Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-024-08715-4 |
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