Study of Pain Catastrophizing (SPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03836586
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study proposes to experimentally manipulate pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain among non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA). Therefore, participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Behavioral: Cognitive-Behavioral Intervention Behavioral: Pain Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Supportive Care
Official Title: Contribution of Pain Catastrophizing to Race Group Differences in Pain and Pain-Related Brain Responses in Older Adults With Knee Osteoarthritis (OA)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Pain Catastrophizing Reduction Group
This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
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.

Active Comparator: Pain Education Group
This group will receive general information about the neurobiology of pain and knee OA.
Behavioral: Pain Education
General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.

Primary Outcome Measures :
  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.'

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03836586

Contact: Ellen Terry, PhD 352-273-5964

United States, Florida
Department of Community Dentistry and Behavioral Science
Gainesville, Florida, United States, 32603
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
UF Brain Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Principal Investigator: Ellen Terry, PhD University of Florida

Responsible Party: University of Florida Identifier: NCT03836586     History of Changes
Other Study ID Numbers: IRB201802819 -N
P30AG059297 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
cognitive-behavior therapy

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases