Study of Pain Catastrophizing-2 (SPAC-2)

Study Overview
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Brief Summary
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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.

Official Title
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Neural Mechanisms Underlying Psychosocial Contributions to Ethnic Group Differences in Pain

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Intervention
* Behavioral: Pain Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catastrophizing, cognitive-behavior therapy