Ulnar Nerve CompressionNCT06090877
US and Shear Wave Elastography in Cubital Tunnel Syndrome
An observational study of Ulnar Nerve Compression, run by Assiut University.
Trial summary
This study aims to assess the role of US and SWE in diagnosis of CuTS and localization of its underlying etiology and verifying whether it can be diagnosed and graded based on US findings, especially quantitaive ulnar nerve stiffness data obtained using SWE, compared to ENMG and intraoperative findings (as gold… Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Ulnar Nerve Compression
- What is being tested?
- US and shear wave elstography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jun 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 10 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: Patient preparation: • No specific preparations needed. 2. Study instruments:- All patients will undergo B-mode ultrasound and SWE using GE Logiq S8 ultrasound machine with 9L-D Linear Array Transducer, at the Radiology Department of Assiut University Hospital, Assuit University.
Who may be able to join
- In this study patients referred from the orthopedic clinic with a clinical diagnosis of clinical cubital tunnel syndrome and having electrodiagnostic studies will be included
Who cannot join
- Lack of electrodiagnostic studies.
- Refuse to do surgery when indicated
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Ultrasound and Shear Wave Elastography in Diagnosis and Grading of Cubital Tunnel Syndrome
This study aims to assess the role of US and SWE in diagnosis of CuTS and localization of its underlying etiology and verifying whether it can be diagnosed and graded based on US findings, especially quantitaive ulnar nerve stiffness data obtained using SWE, compared to ENMG and intraoperative findings (as gold standard)
Read the detailed description
Ulnar nerve (UN) entrapment at the elbow is the second most frequent tunnel syndrome, following carpal tunnel syndrome.
Cubital tunnel syndrome (CuTS) is a common nerve entrapment syndrome of the upper extremity, caused by compression of the ulnar nerve at the cubital tunnel of the elbow.
The presentation of cubital tunnel syndrome varies, ranging from mild sensory symptoms to debilitating functional loss.
Typical CuTS symptoms include numbness, tingling, and dysesthesia in the ring, small finger and dorsum of the hand. As the disease progresses, atrophy of the hypothenar and first dorsal interosseous muscles occurs, which may interfere with daily activities. CuTS is likelier to be at an advanced stage at the time of intervention than carpal tunnel syndrome (CTS). Therefore, early diagnosis and treatment are important.
Also, due to anatomic variations, a broad spectrum of differential diagnosis, and miscellaneous clinical presentations, the clinical diagnosis is often far from straightforward. If not treated timely and adequately, CuTS can progress to persistent impairment of sensation, paresis, and joint contracture.
This condition is typically diagnosed using patient's history, physical examination, and electrodiagnostic studies. However, because CuTS has a variety of clinical characteristics, it is difficult to differentiate it from other diseases that can affect the elbow joint based on clinical presentation and an electrodiagnostic study.
Electroneuromyography (ENMG) is the gold standard examination in CuTS, but sheds no light on etiology.
Although an electrodiagnostic study is considered the most important diagnostic test for CuTS, it has some critical drawbacks. It is time-consuming, causing pain and injury to patients due to needle insertion and electrical stimulation, provides limited information regarding lesion localization and structural abnormalities, and carries a strong possibility of false negative results.
Thus, complementary imaging studies such as magnetic resonance or high resolution ultrasound (HRU) imaging are required for the diagnosis of various neuropathies. Ultrasound imaging in particular supports the diagnosis of neuropathy by providing superior spatial resolution of small peripheral nerves, allowing for dynamic evaluation and detailed information regarding lesion localization in addition to advantages of being fast, cheap, non invasive and painless procedure.
Moreover, as a recently-developed ultrasound imaging technology, shear-wave elastography (SWE) has the potential to provide quantitative values for the soft tissue stiffness of tissues, including the muscle, tendon, joint capsule, benign soft tissue mass, and nerves, and to improve the diagnostic performance of ultrasound imaging for various nerve neuropathies.
SWE is also an advanced quantitative ultrasound technique that can be used to evaluate soft tissue elasticity. In compressive neuropathy, a higher pressure within the canal could cause ischemia, edema, inflammation, and finally fibrosis in the intraneural space and the synovium. All of these changes to the compressed nerve may result in increased nerve stiffness. Therefore, SWE could be a valuable complement in the diagnosis of compressive neuropathy.
So, SWE seems to be a new, reliable, and simple quantitative diagnostic technique to aid in the precise diagnosis of ulnar neuropathy at the cubital tunnel, and HRU proved to be an effective diagnostic tool for CuTS and its etiologies
- Conditions
- Ulnar Nerve Compression
- Being tested
- US and shear wave elstography
- Keywords
- US+shear wave elstography+cubital tunnel syndrome
- Medical subject headings
- Ulnar Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US and shear wave elstographyDevice
Also called electrodiagnostic studies and suitable operation
using B mode US to assess ulnar nerve echogenicity, measuring its cross sectional area and assess any other anatomical abnormalites Measuring ulnar nerve stiffness using shear wave elastography All measurements done at the cubital tunnel, 2 cm proximal and distal to it compare findings with electrodiagnostic studies and intra operative findings
What is being measured
The primary outcome is the main question the study is designed to answer.
US and shear wave elastography findings in diagnosis and grading of cubital tunnel syndrome
measuring cross sectional area and nerve stiffness of the ulnar nerve at cubital tunnel and 2 cm proximal and distal to it as well detection of any anatomical abnormalities, assessing ulnar nerve instability Then findings of US and shear wave elastography will be compared with clinical, electrodiagnostic studies results and intra oprative findings.
Measured: base line
Secondary outcomes (1)
diagnosis and grading of cubital tunnel syndrome
using electrodiagnostic studies as reference to reach cut off values for ulnar nerve cross sectional area and nerve stiffness
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ulnar Nerve CompressionStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Sayed Abdul Monem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090877
- Sponsor's protocol ID
- US in cubital tunnel syndrome
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shinohara I, Inui A, Mifune Y, Nishimoto H, Yamaura K, Mukohara S, Yoshikawa T, Kato T, Furukawa T, Hoshino Y, Matsushita T, Kuroda R. Diagnosis of Cubital Tunnel Syndrome Using Deep Learning on Ultrasonographic Images. Diagnostics (Basel). 2022 Mar 4;12(3):632. doi: 10.3390/diagnostics12030632.
PubMed 35328185Power HA, Peters BR, Patterson JMM, Padovano WM, Mackinnon SE. Classifying the Severity of Cubital Tunnel Syndrome: A Preoperative Grading System Incorporating Electrodiagnostic Parameters. Plast Reconstr Surg. 2022 Jul 1;150(1):115e-126e. doi: 10.1097/PRS.0000000000009255. Epub 2022 May 10.
PubMed 35544306Mezian K, Jacisko J, Kaiser R, Machac S, Steyerova P, Sobotova K, Angerova Y, Nanka O. Ulnar Neuropathy at the Elbow: From Ultrasound Scanning to Treatment. Front Neurol. 2021 May 14;12:661441. doi: 10.3389/fneur.2021.661441. eCollection 2021.
PubMed 34054704Kim S, Lee GY. Evaluation of the ulnar nerve with shear-wave elastography: a potential sonographic method for the diagnosis of ulnar neuropathy. Ultrasonography. 2021 Jul;40(3):349-356. doi: 10.14366/usg.20101. Epub 2020 Aug 23.
PubMed 33115185Rempel DM, Diao E. Entrapment neuropathies: pathophysiology and pathogenesis. J Electromyogr Kinesiol. 2004 Feb;14(1):71-5. doi: 10.1016/j.jelekin.2003.09.009.
PubMed 14759752Qing C, Zhang J, Wu S, Ling Z, Wang S, Li H, Li H. Clinical classification and treatment of cubital tunnel syndrome. Exp Ther Med. 2014 Nov;8(5):1365-1370. doi: 10.3892/etm.2014.1983. Epub 2014 Sep 22.
PubMed 25289024
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound and Shear Wave Elastography in Diagnosis and Grading of Cubital Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06090877
- Acronym / sponsor ID
- US in cubital tunnel syndrome
- Conditions
- Ulnar Nerve Compression
- Keywords
- US+shear wave elstography+cubital tunnel syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Oct 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.
This study aims to assess the role of US and SWE in diagnosis of CuTS and localization of its underlying etiology and verifying whether it can be diagnosed and graded based on US findings, especially quantitaive ulnar nerve stiffness data obtained using SWE, compared to ENMG and intraoperative findings (as gold standard)
Detailed description
Ulnar nerve (UN) entrapment at the elbow is the second most frequent tunnel syndrome, following carpal tunnel syndrome.
Cubital tunnel syndrome (CuTS) is a common nerve entrapment syndrome of the upper extremity, caused by compression of the ulnar nerve at the cubital tunnel of the elbow.
The presentation of cubital tunnel syndrome varies, ranging from mild sensory symptoms to debilitating functional loss.
Typical CuTS symptoms include numbness, tingling, and dysesthesia in the ring, small finger and dorsum of the hand. As the disease progresses, atrophy of the hypothenar and first dorsal interosseous muscles occurs, which may interfere with daily activities. CuTS is likelier to be at an advanced stage at the time of intervention than carpal tunnel syndrome (CTS). Therefore, early diagnosis and treatment are important.
Also, due to anatomic variations, a broad spectrum of differential diagnosis, and miscellaneous clinical presentations, the clinical diagnosis is often far from straightforward. If not treated timely and adequately, CuTS can progress to persistent impairment of sensation, paresis, and joint contracture.
This condition is typically diagnosed using patient's history, physical examination, and electrodiagnostic studies. However, because CuTS has a variety of clinical characteristics, it is difficult to differentiate it from other diseases that can affect the elbow joint based on clinical presentation and an electrodiagnostic study.
Electroneuromyography (ENMG) is the gold standard examination in CuTS, but sheds no light on etiology.
Although an electrodiagnostic study is considered the most important diagnostic test for CuTS, it has some critical drawbacks. It is time-consuming, causing pain and injury to patients due to needle insertion and electrical stimulation, provides limited information regarding lesion localization and structural abnormalities, and carries a strong possibility of false negative results.
Thus, complementary imaging studies such as magnetic resonance or high resolution ultrasound (HRU) imaging are required for the diagnosis of various neuropathies. Ultrasound imaging in particular supports the diagnosis of neuropathy by providing superior spatial resolution of small peripheral nerves, allowing for dynamic evaluation and detailed information regarding lesion localization in addition to advantages of being fast, cheap, non invasive and painless procedure.
Moreover, as a recently-developed ultrasound imaging technology, shear-wave elastography (SWE) has the potential to provide quantitative values for the soft tissue stiffness of tissues, including the muscle, tendon, joint capsule, benign soft tissue mass, and nerves, and to improve the diagnostic performance of ultrasound imaging for various nerve neuropathies.
SWE is also an advanced quantitative ultrasound technique that can be used to evaluate soft tissue elasticity. In compressive neuropathy, a higher pressure within the canal could cause ischemia, edema, inflammation, and finally fibrosis in the intraneural space and the synovium. All of these changes to the compressed nerve may result in increased nerve stiffness. Therefore, SWE could be a valuable complement in the diagnosis of compressive neuropathy.
So, SWE seems to be a new, reliable, and simple quantitative diagnostic technique to aid in the precise diagnosis of ulnar neuropathy at the cubital tunnel, and HRU proved to be an effective diagnostic tool for CuTS and its etiologies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patient preparation: • No specific preparations needed. 2. Study instruments:- All patients will undergo B-mode ultrasound and SWE using GE Logiq S8 ultrasound machine with 9L-D Linear Array Transducer, at the Radiology Department of Assiut University Hospital, Assuit University.
Key inclusion criteria (1 listed)
- In this study patients referred from the orthopedic clinic with a clinical diagnosis of clinical cubital tunnel syndrome and having electrodiagnostic studies will be included
Key exclusion criteria (2 listed)
- Lack of electrodiagnostic studies.
- Refuse to do surgery when indicated
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 |
|---|---|---|
| US and shear wave elstographyAlso: electrodiagnostic studies and suitable operationusing B mode US to assess ulnar nerve echogenicity, measuring its cross sectional area and assess any other anatomical abnormalites Measuring ulnar nerve stiffness using shear wave elastography All measurements done at the cubital tunnel, 2 cm proximal and distal to it compare findings with electrodiagnostic studies and intra operative findings | Device | – |
Primary outcome
US and shear wave elastography findings in diagnosis and grading of cubital tunnel syndrome
Time frame: base line
measuring cross sectional area and nerve stiffness of the ulnar nerve at cubital tunnel and 2 cm proximal and distal to it as well detection of any anatomical abnormalities, assessing ulnar nerve instability Then findings of US and shear wave elastography will be compared with clinical, electrodiagnostic studies results and intra oprative findings.
1 secondary outcome
diagnosis and grading of cubital tunnel syndrome
Time frame: base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 35328185Shinohara I, Inui A, Mifune Y, Nishimoto H, Yamaura K, Mukohara S, Yoshikawa T, Kato T, Furukawa T, Hoshino Y, Matsushita T, Kuroda R. Diagnosis of Cubital Tunnel Syndrome Using Deep Learning on Ultrasonographic Images. Diagnostics (Basel). 2022 Mar 4;12(3):632. doi: 10.3390/diagnostics12030632.
- Background: PubMed 35544306Power HA, Peters BR, Patterson JMM, Padovano WM, Mackinnon SE. Classifying the Severity of Cubital Tunnel Syndrome: A Preoperative Grading System Incorporating Electrodiagnostic Parameters. Plast Reconstr Surg. 2022 Jul 1;150(1):115e-126e. doi: 10.1097/PRS.0000000000009255. Epub 2022 May 10.
- Background: PubMed 34054704Mezian K, Jacisko J, Kaiser R, Machac S, Steyerova P, Sobotova K, Angerova Y, Nanka O. Ulnar Neuropathy at the Elbow: From Ultrasound Scanning to Treatment. Front Neurol. 2021 May 14;12:661441. doi: 10.3389/fneur.2021.661441. eCollection 2021.
- Background: PubMed 33115185Kim S, Lee GY. Evaluation of the ulnar nerve with shear-wave elastography: a potential sonographic method for the diagnosis of ulnar neuropathy. Ultrasonography. 2021 Jul;40(3):349-356. doi: 10.14366/usg.20101. Epub 2020 Aug 23.
- Background: PubMed 14759752Rempel DM, Diao E. Entrapment neuropathies: pathophysiology and pathogenesis. J Electromyogr Kinesiol. 2004 Feb;14(1):71-5. doi: 10.1016/j.jelekin.2003.09.009.
- Background: PubMed 25289024Qing C, Zhang J, Wu S, Ling Z, Wang S, Li H, Li H. Clinical classification and treatment of cubital tunnel syndrome. Exp Ther Med. 2014 Nov;8(5):1365-1370. doi: 10.3892/etm.2014.1983. Epub 2014 Sep 22.
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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 Ulnar Nerve Compression, 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 19 Oct 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 Eman Sayed, master (01019870725, eman11486@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
US and shear wave elastography findings in diagnosis and grading of cubital tunnel syndrome (time frame: base line). 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 NCT06090877, which also lists 6 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 19 Oct 2023.