Study of Pain Catastrophizing

NCT03836586 | Completed Results

• 3 other identifiers: IRB201802819 -NP30AG059297K22NS102334
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee

Keywords

catastrophizing; cognitive-behavior therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pain Catastrophizing Reduction Group

EXPERIMENTAL

This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.

Behavioral: Cognitive-Behavioral Intervention

Pain Education Group

ACTIVE COMPARATOR

This group will receive general information about the neurobiology of pain and knee OA.

Behavioral: Pain Education

Interventions

Cognitive-Behavioral Intervention BEHAVIORAL

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 Catastrophizing Reduction Group

Pain Education BEHAVIORAL

General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.

Pain Education Group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic knee OA

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Results Point of Contact

• Title: Dr. Ellen Terry
• Organization: University of Florida

elterry@ufl.edu

352-273-6441

Study Officials

• Ellen Terry, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 11, 2019
• Study Start: December 23, 2019
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: April 19, 2024
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)