Study of Pain Catastrophizing-2 (SPAC-2)

University of Florida

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Behavioral: Cognitive-Behavioral Intervention; Behavioral: Pain Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04805190

K22NS102334 (U.S. NIH Grant/Contract)

IRB202100297 -N

OCR40441 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 99 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

---

99 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