Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2021-10-15
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Pain Catastrophizing Reduction Group
This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
Cognitive-Behavioral Intervention
This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.
Pain Education Group
This group will receive general information about the neurobiology of pain and knee OA.
Pain Education
General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
Interventions
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Cognitive-Behavioral Intervention
This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.
Pain Education
General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prosthetic knee replacement or other clinically significant surgery to the arthritic knee
* Uncontrolled hypertension (\>150/95)
* Heart disease including heart failure
* Peripheral neuropathy in which pain testing was contraindicated
* Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia
* Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures
* Significantly greater pain in body sites other than in the knee
* Daily opioid use
* Hospitalization within the preceding year for psychiatric illness
* Currently pregnant or nursing/breastfeeding
45 Years
85 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Ellen Terry, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health at the University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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OCR40441
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202100297 -N
Identifier Type: -
Identifier Source: org_study_id
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