Study of Pain Catastrophizing (SPAC)

Contribution of Pain Catastrophizing to Race Group Differences in Pain and Pain-Related Brain Responses in Older Adults With Knee Osteoarthritis (OA)

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Intervention; Behavioral: Pain Education

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Catastrophizing Reduction Group; This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.	Behavioral: 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.
Active Comparator: Pain Education Group; This group will receive general information about the neurobiology of pain and knee OA.	Behavioral: Pain Education; General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale (PCS) at 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.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.	Day 2

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ellen Terry, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: catastrophizing; cognitive-behavior therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRB201802819 -N; P30AG059297 (U.S. NIH Grant/Contract); K22NS102334 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No