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Study of Pain Catastrophizing-2 (SPAC-2)

Neural Mechanisms Underlying Psychosocial Contributions to Ethnic Group Differences in Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04805190
Acronym
SPAC
Enrollment
99
Registered
2021-03-18
Start date
2021-10-15
Completion date
2023-12-12
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

catastrophizing, cognitive-behavior therapy

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.

Interventions

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.

BEHAVIORALPain Education

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

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

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

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Catastrophizing Scale (PCS)Baseline; Day 213-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.'

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026