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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13121654
Enrollment
100
Registered
2026-03-24
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Rheumatoid arthritis Musculoskeletal Diseases

Interventions

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) join

Sponsors

The Ottawa Hospital Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Biological sex of the patients will be used to categorize them as males and females to compare fMRI features in female vs male RA patients with similar disease activities, on resting state and after pain induction.

Secondary

MeasureTime frame
1. Fibromyalgia diagnosis will be based on the Widespread Pain Index (score =4 categorized as fibromyalgia). 2.US positivity will be based on the cut-off of grade=2 synovitis and Doppler signals: -US positive if they have at least one MCP joint with grade=2 synovitis and Doppler signals; -The US is negative if they do not have any MCP joints with grade=2 synovitis and Doppler signals. -The joint that will be exposed to pain stimulation during the fMRI will be the joint that has the highest degree of US inflammation (for US-positive patients) or the most tender joint (US-negative patients). In the case of more than one MCP joint with similar features, the 2nd MCP joint will be used.

Countries

Canada

Contacts

Public ContactSibel Aydin
saydin@ohri.ca+1 6137378899

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026