NCT06135129

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 12, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

Elastography

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline

Interventions

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

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with RA and ruling out CTS by clinical evaluation

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 17170055BACKGROUND
  • 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.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Marco Magdy, Resident doctor

CONTACT

Ahmed Mustafa, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11