Identifying factors leading to chronic pain in rheumatoid arthritis

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

This study is trying to find out what factors can lead to long-lasting pain in people with early rheumatoid arthritis by looking at their responses to pain and brain images over time.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 5 sites (Denver, Colorado and 4 other locations)
• Trial ID: NCT05038553 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify modifiable clinical factors and neurobiological pathways that contribute to chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing to assess their responses to painful stimuli at baseline, 3 months, and 12 months. Additionally, a subset of participants will receive magnetic resonance imaging to evaluate neuroimaging markers associated with chronic pain at the start and after 12 months. The study does not involve any interventions but focuses on understanding the underlying mechanisms of pain.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with early rheumatoid arthritis and persistent joint symptoms for less than 2 years.

Not a fit: Patients with routine opioid use or significant comorbidities like peripheral neuropathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for chronic pain in rheumatoid arthritis patients.

How similar studies have performed: Other studies have explored similar neurobiological pathways in chronic pain, indicating potential for success in this approach.

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

Where this trial is running

Denver, Colorado and 4 other locations

• University of Colorado — Denver, Colorado, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Hospital for Special Surgery — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Yvonne C Lee, MD, MMSc — Northwestern University
• Study coordinator: Kathleen Aren, MPH

Conditions Arthritis, Rheumatoid; Pain