Study of Pain Catastrophizing-2 (SPAC-2)

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Behavioral: Cognitive-Behavioral Intervention; Behavioral: Pain Education

• Registration Number: NCT04805190
• Lead Sponsor: University of Florida

Brief Summary

This study experimentally manipulates pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain in different ethnic groups among adults with knee osteoarthritis. Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Study Start: 2021-10-15
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Catastrophizing Reduction Group	Cognitive-Behavioral Intervention	This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
Pain Education Group	Pain Education	This group will receive general information about the neurobiology of pain and knee OA.

Primary Outcome Measures

Name	Time	Method
Change in Pain Catastrophizing Scale (PCS)	Baseline; Day 2	13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing ("Thinking back to your experience during the laboratory pain testing"). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.'

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States