A multidimensional approach to pain in rheumatoid arthritis to understand sex differences using functional brain imaging and joint ultrasound

Registry ID
ISRCTN13121654
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
The Ottawa Hospital Research Institute
Enrollment
100
Start date
2026-03-01
Completion date
2027-12-31
Last update
2026-08-17

Conditions

Summary

Rheumatoid arthritis

Detailed description

Ultrasound: We will perform the MSUS on the same day of the clinical assessment, the sonographer being blinded to all the clinical data. The US will be performed for the metacarpophalangeal (MCP) joints (2nd-5th) from the dorsal view. This would take 15-20 minutes. fMRI procedure of the brain and application of mild pressure using a vector-adjusted vascular cuff: The fMRI procedure will take approximately 45-60 minutes to complete Questionnaires (HAQ, McGill Pain Questionnaire, Widespread Pain Index, Symptom Severity Scale, and Polysymptomatic Distress (PSD) Score): Completion would take about 10 mins Follow-up: A 3-month follow-up would be conducted only if the participant starts a new biologic therapy.

Interventions

Inclusion criteria

1. Adult patients (≥18 years) having RA fulfilling the 2010 ACR/EULAR classification criteria (21) 2. Moderate-to-high disease activity according to DAS28ESR (22) 3. Tenderness and swelling in any metacarpophalangeal joint in the right hand

Exclusion criteria

1. Pregnancy (current or planned within the study period) or breastfeeding; 2. Inability to give informed consent, 3. Failure to communicate verbal or written responses to questionnaires; 4. >7.5 mg/day of prednisone (or equivalent) used two weeks before the baseline visit; 5. The presence of contraindications for MRI, such as magnetic prosthesis in the body; 6. Use of medications that can alter brain activity or known psychiatric diseases that can alter brain activity (23). 7. Swelling in both hands will not constitute an exclusion criterion; however, patients with pain and swelling in the right hand will be included, and the most painful joint in the right hand will be selected for pain stimulation.

Locations

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