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Chronic Pain in Rheumatoid Arthritis

CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05038553
Acronym
CPIRA-2
Enrollment
125
Registered
2021-09-09
Start date
2021-10-12
Completion date
2027-02-28
Last updated
2026-05-28

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

Conditions

Arthritis, Rheumatoid, Pain

Brief summary

The objective is to identify modifiable clinical factors and neurobiological pathways that lead to the development of chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing, a type of testing that involves assessing response to well-defined, quantifiable painful stimuli, at 0, 3, and 12 months. A subset of participants will also undergo magnetic resonance imaging at 0 and 12 months to assess neuroimaging markers that have previously been shown to be involved in chronic pain.

Interventions

OTHERNo intervention

No intervention

Sponsors

Northwestern University
Lead SponsorOTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Michigan
CollaboratorOTHER
Hospital for Special Surgery, New York
CollaboratorOTHER
University of Colorado, Denver
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for QST: 1. Age ≥18 years 2. Meet either the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA 3. Persistent joint symptoms ≤ 2 years 4. Active inflammatory disease 5. If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures 6. If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures 7. If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study

Exclusion criteria

for QST: 1. Routine, scheduled opioid use 2. Routine, scheduled prednisone dose \>10 mg or its equivalent 3. Peripheral neuropathy 4. Peripheral vascular disease 5. Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain 6. Uncontrolled blood pressure Additional Inclusion Criteria for neuroimaging: 1. Age ≤ 80 years old 2. Right-handed or ambidextrous 3. Ability to lie on their back for the duration of the MRI scans Additional

Design outcomes

Primary

MeasureTime frameDescription
Fibromyalgia Survey Criteria12 monthsMinimum value 0, maximum value 31; higher scores indicate worse outcomes

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORYvonne C Lee, MD, MMSc

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026