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Completed

NCT Number: NCT04805190

Study of Pain Catastrophizing-2 (SPAC-2)

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 education

Behavioral

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

Primary outcomes

  1. Change in Pain Catastrophizing Scale (PCS)

    Time frame: Baseline; 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.'

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Neural Mechanisms Underlying Psychosocial Contributions to Ethnic Group Differences in Pain

Acronym: SPAC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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