Rheumatoid ArthritisNCT06135129
SonoElastography of Median Nerve in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Sonoelastography
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients diagnosed with RA and ruling out CTS by clinical evaluation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Value of SonoElastography in Evaluation of Median Nerve Changes With Rheumatoid Arthritis Patients Without Symptoms of Carpal Tunnel Syndrome
To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA.
Read the 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
- Being tested
- Sonoelastography
- Keywords
- Elastography
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoelastographyDevice
Sonoelastography (SE) is a new ultrasound-based method measure the stiffness or elasticity of tissues, has no hazards on poatients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Magdy Wadie, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135129
- Sponsor's protocol ID
- Elastography median nerve
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17170055Atan 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.
PubMed 37680523
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of SonoElastography in Evaluation of Median Nerve Changes With Rheumatoid Arthritis Patients Without Symptoms of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06135129
- Acronym / sponsor ID
- Elastography median nerve
- Conditions
- Rheumatoid Arthritis
- Keywords
- Elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with RA and ruling out CTS by clinical evaluation
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoelastographySonoelastography (SE) is a new ultrasound-based method measure the stiffness or elasticity of tissues, has no hazards on poatients. | Device | – |
Primary outcome
To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA.
Time frame: Baseline
The accuracy of Sonoelastography to detect median nerve changes in rheumatoid arthritis patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 17170055Hammer 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.
- Results publication: PubMed 37680523Atan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Magdy, Resident doctor (01270777143, marcomagdy1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.