SonoElastography of Median Nerve in Rheumatoid Arthritis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06135129
Collaborator
(none)
71
13

Study Details

Study Description

Brief Summary

To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA.

Condition or Disease Intervention/Treatment Phase
  • Device: Sonoelastography

Detailed Description

Rheumatoid arthritis (RA) presents with persistent pain, stiffness, progressive joint destruction, functional disability, and progressive morbidity and mortality, and is a chronic systemic autoimmune disease.1 The cause of RA remains unknown, but the pathological mechanism of synovial inflammation may result due to the complex interplay of genetic immunology and environmental factors.2 Early diagnosis is fundamental to prevent the permanent sequel of RA. Recent advances in diagnostic imaging in rheumatology have benefited patients clinically and also provided information related to the pathophysiology of diseases like arthritis.

Ultrasound (US) and magnetic resonance imaging were most commonly used in diagnosing and monitoring RA progression in joints and related joint structures.3 US elastography measures tissue elasticity using high-frequency sound waves to assess tissue's static or dynamic deformation behavior after a stimulus is applied. This technique has been described most commonly in the context of isotropic tissues, such as the liver and neoplastic diseases, but is now becoming of more interest in anisotropic tissues, such as those in the musculoskeletal system.4

Study Design

Study Type:
Observational
Anticipated Enrollment :
71 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnostic Value of SonoElastography in Evaluation of Median Nerve Changes With Rheumatoid Arthritis Patients Without Symptoms of Carpal Tunnel Syndrome
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA. [Baseline]

    The accuracy of Sonoelastography to detect median nerve changes in rheumatoid arthritis patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All patients diagnosed with RA and ruling out CTS by clinical evaluation that included Phalen's test, a manual muscle test of the abductor's muscle, and a search for Tinel-like signs and thenar muscle atrophy. Controls - Age- and sex- matched cases without RA undergoing US for causes unrelated to RA or CTS. The criteria for RA were adopted from The American Rheumatism Association (1987) for the classification of RA.
Exclusion Criteria:
  • History of a condition other than RA that could cause CTS (e.g., diabetes mellitus, acute trauma, pregnancy ,hypothyroidism, hyperthyroidism, connective tissue disease)History of surgery for a wrist or hand fracture.

  • History of other systemic neurological disorders or radiculopathy Bifid median nerve or any mass lesion identified on US examination Pregnant patients were excluded.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marco Magdy Wadie, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06135129
Other Study ID Numbers:
  • Elastography median nerve
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marco Magdy Wadie, Resident doctor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023