SonoElastography of Median Nerve in Rheumatoid Arthritis

NCT ID: NCT06135129

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-01-31

Brief Summary

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

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

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Sonoelastography

Sonoelastography (SE) is a new ultrasound-based method measure the stiffness or elasticity of tissues, has no hazards on poatients.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marco Magdy Wadie

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marco Magdy, Resident doctor

Role: CONTACT

marcomagdy1997@gmail.com

01270777143

Ahmed Mustafa, professor

Role: CONTACT

ahmed.hamed2@med.aun.edu.eg

01000024182

References

Hammer HB, Haavardsholm EA, Kvien TK. Ultrasonographic measurement of the median nerve in patients with rheumatoid arthritis without symptoms or signs of carpal tunnel syndrome. Ann Rheum Dis. 2007 Jun;66(6):825-7. doi: 10.1136/ard.2006.055988. Epub 2006 Dec 14.

Reference Type: BACKGROUND

PMID: 17170055 (View on PubMed)

Atan Uzun C, Sunar I, Gunendi Z, Gogus FN. Comparison of the median and ulnar nerves of rheumatoid arthritis patients and healthy subjects by ultrasound. Arch Rheumatol. 2022 Oct 21;38(2):183-188. doi: 10.46497/ArchRheumatol.2023.9027. eCollection 2023 Jun.

Reference Type: RESULT

PMID: 37680523 (View on PubMed)

Other Identifiers

Elastography median nerve

Identifier Type: -

Identifier Source: org_study_id