Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400329
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-25
Brief Title:
Physiological Impact of Different Types of Osteoarthritis Education Education
Sponsor:
Lisa Carlesso
Organization:
McMaster University
Study Overview
Official Title:
Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNE
Brief Summary:
In this study the investigators are comparing two types of education for older adults with knee osteoarthritis standard biomedical education focusing on the disease process and a newer approach called pain neuroscience education PNE which teaches about the complexity of pain and dispels myths While PNE has shown benefits in self-reported pain and function little is known about its effects on physiological responses to pain
the investigators will measure physiological indicators particularly activity in the autonomic nervous system ANS which is closely linked to pain Dysregulation in the ANS is common in chronic pain conditions like osteoarthritis Our study aims to assess the feasibility of comparing these education methods and explore differences in physiological responses as well as self-reported outcomes like cognitive and emotional factors
Our goals are to determine if the study protocol is feasible assess participants acceptance of the assessment procedures and explore differences in physiological markers and self-reported outcomes between the two education groups Ultimately the investigators aim to understand how different educational approaches may affect nervous system processing in older adults with knee osteoarthritis the investigators hypothesize that those receiving PNE will show less autonomic arousal and nervous system sensitivity compared to those receiving standard education
the investigators will measure physiological indicators particularly activity in the autonomic nervous system ANS which is closely linked to pain Dysregulation in the ANS is common in chronic pain conditions like osteoarthritis Our study aims to assess the feasibility of comparing these education methods and explore differences in physiological responses as well as self-reported outcomes like cognitive and emotional factors
Our goals are to determine if the study protocol is feasible assess participants acceptance of the assessment procedures and explore differences in physiological markers and self-reported outcomes between the two education groups Ultimately the investigators aim to understand how different educational approaches may affect nervous system processing in older adults with knee osteoarthritis the investigators hypothesize that those receiving PNE will show less autonomic arousal and nervous system sensitivity compared to those receiving standard education
Detailed Description:
Education and understanding of musculoskeletal MSK pain is known to be important for individuals and can improve patient outcomes ie pain and function1 Many years ago it became apparent that there was a vast disconnect between the scientific understanding of pain ie its protective function its complexity and the most effective ways of treating it and the current understanding of how pain works held by patients and health professionals alike2 one that was entrenched in an outdated biomedical model Traditionally education has focused on the disease process which can have a negative impact with its language and images due to its focus on structural pathology3 Additionally despite the known benefits of certain interventions eg exercise for MSK disorders people may be wrongly advised that too much exercise could cause joint pain and damage4 Many of these poorly construed messages are due to a lack of understanding of the impact of such language the complexity of the pain experience and its lack of correlation with what the investigators now consider to be normal age-related changes seen on imaging2 The aim of intensive education about pain neuroscience was to give credibility to the best treatments available - active psychological and self-management skills by providing a modern understanding of how pain works with the hope of giving power and agency to individuals to make optimal decisions about how to manage their health situation Simply put PNE aimed to enable and empower patients to adopt a biopsychosocial understanding of their problem and thereby pursue a biopsychosocial-based approach to overcoming it2 PNE involves the process of educating individuals about the complexity of pain and how our bodies process pain It also seeks to dispel many of the myths long held by the public regarding MSK disorders5 Despite PNE showing consistent positive effects on self-reported pain and function there has been a growing debate in the literature regarding its value67 Interestingly there has been little to no evaluation of how differing approaches to education impacts peoples physiological reactions and nervous system processing of pain This project will fill that gap by providing unique understanding of how the type of educational content provided to older adults with knee osteoarthritis may impact their nervous system functioning and processing of pain
Measuring pain remains a challenge especially from a psycho-physiological aspect8 Among various physiological indicators the activity of the autonomic nervous system ANS specifically its sympathetic and parasympathetic subdivisions is closely associated with pain 9 Enhanced activity in the sympathetic nervous system leads to increased electrodermal activity sweating respiration rate heart rate blood pressure vascular vasoconstriction and pupil dilation In states of chronic pain the autonomic nervous system may experience dysregulation often resulting in diminished autonomic responsiveness to painful or stressful stimuli Autonomic dysfunction has been observed in various chronic conditions including knee osteoarthritis10 low back pain9 rheumatoid arthritis11 and fibromyalgia12 Targeting the dysregulated autonomic nervous system could potentially restore balance to stress response systems and alleviate systemic inflammation The purpose of this pilot study will be to evaluate 1 the feasibility of a study protocol to investigate if there are differences in physiological responses associated with exposure to different types of knee osteoarthritis educational content 2 to explore differences in the physiological responses between exposure to pain neuroscience education and standard biomedical education and 3 to explore differences in self-reported cognitive emotional and functional outcomes and the physiological responses in each intervention arm
Measuring pain remains a challenge especially from a psycho-physiological aspect8 Among various physiological indicators the activity of the autonomic nervous system ANS specifically its sympathetic and parasympathetic subdivisions is closely associated with pain 9 Enhanced activity in the sympathetic nervous system leads to increased electrodermal activity sweating respiration rate heart rate blood pressure vascular vasoconstriction and pupil dilation In states of chronic pain the autonomic nervous system may experience dysregulation often resulting in diminished autonomic responsiveness to painful or stressful stimuli Autonomic dysfunction has been observed in various chronic conditions including knee osteoarthritis10 low back pain9 rheumatoid arthritis11 and fibromyalgia12 Targeting the dysregulated autonomic nervous system could potentially restore balance to stress response systems and alleviate systemic inflammation The purpose of this pilot study will be to evaluate 1 the feasibility of a study protocol to investigate if there are differences in physiological responses associated with exposure to different types of knee osteoarthritis educational content 2 to explore differences in the physiological responses between exposure to pain neuroscience education and standard biomedical education and 3 to explore differences in self-reported cognitive emotional and functional outcomes and the physiological responses in each intervention arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None