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Study of Pain Catastrophizing-2 (SPAC-2) (SPAC)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Intervention
Pain Education
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring catastrophizing, cognitive-behavior therapy

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health at the University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Catastrophizing Reduction Group

Pain Education Group

Arm Description

This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.

This group will receive general information about the neurobiology of pain and knee OA.

Outcomes

Primary Outcome Measures

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.'

Secondary Outcome Measures

Full Information

First Posted
March 15, 2021
Last Updated
November 21, 2022
Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT04805190
Brief Title
Study of Pain Catastrophizing-2 (SPAC-2)
Acronym
SPAC
Official Title
Neural Mechanisms Underlying Psychosocial Contributions to Ethnic Group Differences in Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
catastrophizing, cognitive-behavior therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Catastrophizing Reduction Group
Arm Type
Experimental
Arm Description
This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
Arm Title
Pain Education Group
Arm Type
Active Comparator
Arm Description
This group will receive general information about the neurobiology of pain and knee OA.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Education
Intervention Description
General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
Primary Outcome Measure Information:
Title
Change in Pain Catastrophizing Scale (PCS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Terry, PhD
Phone
352-273-6441
Email
elterry@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Terry, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Terry, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Pain Catastrophizing-2 (SPAC-2)

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