N/A
N=10
Study of Pain Catastrophizing
Osteo Arthritis Knee
Bottom Line
View on ClinicalTrials.gov: NCT03836586 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Pain Catastrophizing Scale (PCS) at Day 2 — 20.40; 15.25 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive-Behavioral Intervention (Behavioral); Pain Education (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Catastrophizing Scale (PCS) at Day 2 |
20.40; 15.25 | — |
Summary
This study proposes to experimentally manipulate pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain among non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA). Therefore, participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.
Eligibility Criteria
Inclusion Criteria
- symptomatic knee OA
Exclusion Criteria
- Younger than 45 years of age or older than 85 years of age
- 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
Data sourced from ClinicalTrials.gov (NCT03836586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.