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Study of Pain Catastrophizing (SPAC)

University of Florida logo

University of Florida

Status

Completed

Conditions

Osteo Arthritis Knee

Treatments

Behavioral: Pain Education
Behavioral: Cognitive-Behavioral Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03836586
K22NS102334 (U.S. NIH Grant/Contract)
IRB201802819 -N
P30AG059297 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

Pain Catastrophizing Reduction Group
Experimental group
Description:
This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
Treatment:
Behavioral: Cognitive-Behavioral Intervention
Pain Education Group
Active Comparator group
Description:
This group will receive general information about the neurobiology of pain and knee OA.
Treatment:
Behavioral: Pain Education

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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