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Chronic Pain in Rheumatoid Arthritis
NCT05038553 · Northwestern University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition
About this study
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.
Eligibility criteria
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 Exclusion Criteria for neuroimaging:
1. Severe claustrophobia precluding MRI
2. Unable to fit comfortably in the MRI scanner (usually only occurs if body mass index \>40 kg/m2)
3. Pregnant
4. Contraindications to MRI
Study design
Enrollment target: 125 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-10-12
Estimated completion: 2026-04-30
Last updated: 2025-04-29
Interventions
Other: No intervention
Primary outcomes
- • Fibromyalgia Survey Criteria (12 months)
Sponsor
Northwestern University · other
With: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Michigan, Hospital for Special Surgery, New York, University of Colorado, Denver, Johns Hopkins University
Contacts & investigators
ContactKathleen Aren, MPH · contact · kathleen.aren@northwestern.edu · 312-503-1824
ContactMary Carns, MS · contact · m-carns@northwestern.edu · 312-503-1137
InvestigatorYvonne C Lee, MD, MMSc · principal_investigator, Northwestern University
All locations (5)
University of ColoradoRecruiting
Denver, Colorado, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Hospital for Special SurgeryRecruiting
New York, New York, United States