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Behavioural Intervention
Pain Education for Osteoarthritis (PNE Trial)
N/A
Recruiting
Led By Lisa Carlesso, PhD
Research Sponsored by Lisa Carlesso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥55 years old
either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two types of education for older adults with knee osteoarthritis: standard biomedical education and pain neuroscience education (PNE) which focuses on pain complexity and dispelling myths. The study
Who is the study for?
This trial is for adults over 55 with knee osteoarthritis, experiencing joint pain related to activity and minimal morning stiffness. It's aimed at community-dwelling individuals who either have a diagnosis of knee OA or meet the NICE criteria for it.
What is being tested?
The study compares two educational methods: standard biomedical education about osteoarthritis and pain neuroscience education (PNE), which addresses the complexity of pain. The focus is on how these affect physiological responses to pain in the nervous system.
What are the potential side effects?
Since this trial involves educational interventions rather than medications, there are no direct side effects like those associated with drugs. However, participants may experience varying psychological impacts from the information provided.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
I don't have morning joint stiffness, or it lasts less than 30 minutes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Burden of the assessments
Feasibility outcomes (Educational content and format acceptability)
Feasibility outcomes (Lab Site accessibility/ Participant Convenience)
+2 moreSecondary study objectives
Anxiety symptoms
Chronic pain self-efficacy
Demographic information
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pain neuroscience educationExperimental Treatment1 Intervention
The educational content will be presented to the participants at a computer station in the format of a website to navigate to simulate the experience and information that they may come across while browsing the internet for information about knee OA. The content will include 4 components, regardless of the education type. These components include knee osteoarthritis (OA)-related images, facts and myths, disease related concepts, and patient-doctor statements. The distinction between the two educational approaches lies in how information is presented. PNE focuses more on the neurophysiology of pain and approaches it from the perspective that knee OA pain is manageable, using neutral to positive language and emphasizes the importance of physical function and staying active. After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown.
Group II: Biomedical educationActive Control1 Intervention
In Standard Pain Education, the emphasis is on the structural pathology of knee OA and the outdated but common understanding of the disease process as a degenerative one, potentially conveying negative and threatening language.
After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown.
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Who is running the clinical trial?
Lisa CarlessoLead Sponsor
Lisa Carlesso, PhDPrincipal InvestigatorMcMaster University
4 Previous Clinical Trials
190 Total Patients Enrolled
3 Trials studying Osteoarthritis
153 Patients Enrolled for Osteoarthritis
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