Study of Pain Catastrophizing-2 (SPAC-2)

University of Florida99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Cognitive-Behavioral InterventionBEHAVIORAL

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 EducationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

UF Health at the University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.'

Time frame: Baseline; Day 2

Data from ClinicalTrials.gov

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