Study of Pain Catastrophizing-2 (SPAC-2)

Osteoarthritis, Knee Clinical Trial

— SPAC  

Official title:

Neural Mechanisms Underlying Psychosocial Contributions to Ethnic Group Differences in Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805190
• Other study ID #: IRB202100297 -N
• Secondary ID: K22NS102334OCR40
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 12, 2023

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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