Study of Pain Catastrophizing-2 (SPAC-2)

NCT04805190 | Completed

• 3 other identifiers: IRB202100297 -NK22NS102334OCR40441
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

catastrophizing; cognitive-behavior therapy

Outcome Measures

Primary Outcomes (1)

• Change in Pain Catastrophizing Scale (PCS)

  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.'

  Baseline; 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 of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ellen Terry, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

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: March 15, 2021
• First Posted: March 18, 2021
• Study Start: October 15, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)