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NCT05038553 | RECRUITING | Arthritis, Rheumatoid

Chronic Pain in Rheumatoid Arthritis
Sponsor:

Northwestern University

Information provided by (Responsible Party):

Yvonne Lee

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.

Condition or disease

Arthritis, Rheumatoid

Pain

Intervention/treatment

No intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 125 participants
Official Title : CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition
Actual Study Start Date : 2021-10-12
Estimated Primary Completion Date : 2026-02-27
Estimated Study Completion Date : 2026-04-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Chronic Pain in Rheumatoid Arthritis

Location Details

NCT05038553

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado

Denver, Colorado, United States, 80045

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21224

RECRUITING

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48019

RECRUITING

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021