Carpal Tunnel Syndrome BilateralNCT03213847
Superb Microvascular Imaging of Median Nerve in Carpal Tunnel Syndrome: A Novel Technique in Diagnostic Ultrasound
A study testing Superb microvascular imaging (SMI) (Toshiba) in people with Carpal Tunnel Syndrome Bilateral, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine whether there is a correlation between the increased intraneural flow as measured using Doppler ultrasound (US) and superb microvascular imaging (SMI) methods and the severity of CTS as measured by nerve conduction studies. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Carpal Tunnel Syndrome Bilateral
- What is being tested?
- Superb microvascular imaging (SMI) (Toshiba)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2017to 25 Nov 2017
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who diagnosed as as mild, moderate or severe CTS with electromyography
- Age between 18-45
Who cannot join
- History of upper extremity trauma
- Diabetes mellitus
- Pregnancy,
- Rheumatological diseases
- Hypothyroidism
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to determine whether there is a correlation between the increased intraneural flow as measured using Doppler ultrasound (US) and superb microvascular imaging (SMI) methods and the severity of CTS as measured by nerve conduction studies. Moreover, investigators investigated the association of increased intraneural flow with the cross sectional area of the median nerve. The null hypothesis that there is no correlation between increased intraneural flow and the severity of carpal tunnel syndrome.
Read the detailed description
Thanks to ultrasound (US) has a low cost, portable, available and non-invasive, the use of diagnostic US in musculoskeletal diseases is rapidly growing in worldwide. Because it is easy to identify the limb structures such as muscle, tendon, and nerves and also, their pathologies, US is frequently used by physiatrists, orthopedics, rheumatologists, sports medicine and pain management physicians nowadays. Providing images of the median nerve (MN) and accompanying structures and give dynamic images about the anatomy of the carpal tunnel are the most superiorities of US in carpal tunnel syndrome (CTS) diagnosis. The diagnose of CTS based on history and physical examination and confirmed with electrodiagnostic studies. Although the specificity of nerve conduction tests is high, there is significant variability in sensitivity (62-85%). Therefore, US has been suggested as an additional or alternative diagnose of CTS. Especially measurement of the cross-sectional area (CSA) of the MN is significantly greater in CTS patients and shows a significant correlation with electrodiagnostic findings such as sensory nerve conduction velocity (SCV) and distal motor latency (DML). Because it enhances the diagnostic accuracy the detection of the epineural or intraneuronal blood flow, the three techniques of Doppler US, are more recently preferred. The contributions of color, power and spectral Doppler techniques in CTS diagnosis, were studied in various studies before. While for the detection of intraneural flow, the power Doppler (PD) seems to be the best way, the specify, sensitivity and diagnostic accuracy of each Doppler techniques were good in most studies.
Superb microvascular imaging (SMI) (Toshiba Medical Systems, Tokyo, Japan) is a new era in diagnostic ultrasound image processing technique. This new technology assigns accurate visualization of vascular structures with intensive clutter suppression to provide flow signals large to small vessels and represent this data at high frame rates. The both of the two modes (color SMI (cSMI) and the monochrome SMI (mSMI)) of the SMI, allows to visualizing lower velocity blood flows and smaller vessels without the use of contrast medium. To the best of our knowledge, there have been no clinical trials which studied of the healthy or injured median nerve blood flow with SMI.
The aim of the study was to compare the diagnostic value of Doppler US and SMI methods in CTS based on detection of increased intraneural flow. Moreover, investigators investigated the association of increased intraneural flow with the CSA of the MN. The null hypothesis that there is no difference between Doppler US and SMI methods in the detection of increased intraneural flow in CTS patients.
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Being tested
- Superb microvascular imaging (SMI) (Toshiba)
- Keywords
- Carpal Tunnel Syndrome, Superb microvascular imaging, Doppler ultrasound, Ultrasound, Median Nerve Entrapment, Diagnoses Disease
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superb microvascular imaging (SMI) (Toshiba)Device
to determine whether there is a correlation between the increased intraneural flow as measured using Doppler US and SMI methods and the severity of CTS as measured by nerve conduction studies, we designed this study
| Study group | Role | What they receive |
|---|---|---|
| Participants with carpal tunnel syndrome | Other | Participants diagnosed with carpal tunnel syndrome; will be evaluated with Doppler ultrasound and superb microvascular imaging (SMI) ultrasound. The results of these two evaluations will be compared between each other in according to severity of carpal tunnel syndrome (severity will be determined by electromyography studies) Receives: Device: Superb microvascular imaging (SMI) (Toshiba) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular blood flow images from median nerve (enterrapted in carpal tunnel) obtained with Power Doppler and Superb microvascular imaging.
Four-stage classify will be use for grading these images; Grade 0: No vascularity in MN, Grade 1: One or two focal color-encoded spots in MN, Grade 2: One linear color-encoded line or more than two focal color-encoded spots in MN, Grade 3: More than one linear color-encoded line in MN
Measured: Each participant will be assessed only one time at the admission time to the outpatient clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start20 Oct 2017
- Primary completion20 Nov 2017
- Study completion25 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome BilateralStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yavuz Karahan, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213847
- Sponsor's protocol ID
- SMI001
- Status last verified
- Oct 2018
- First submitted
- 6 Jul 2017
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anthropometric and demographic data included age, weight, height, body mass index (BMI), gender, occupation, medication history and hand dominance. Main outcomes of the study: correlation between the increased intraneural flow as measured using Doppler US and Superb microvascular imaging (SMI) methods.
Publications
Orlandi D, Gitto S, Perugin Bernardi S, Corazza A, De Flaviis L, Silvestri E, Cimmino MA, Sconfienza LM. Advanced Power Doppler Technique Increases Synovial Vascularity Detection in Patients with Rheumatoid Arthritis. Ultrasound Med Biol. 2017 Sep;43(9):1880-1887. doi: 10.1016/j.ultrasmedbio.2017.05.004. Epub 2017 Jun 17.
PubMed 28629689Akcar N, Ozkan S, Mehmetoglu O, Calisir C, Adapinar B. Value of power Doppler and gray-scale US in the diagnosis of carpal tunnel syndrome: contribution of cross-sectional area just before the tunnel inlet as compared with the cross-sectional area at the tunnel. Korean J Radiol. 2010 Nov-Dec;11(6):632-9. doi: 10.3348/kjr.2010.11.6.632. Epub 2010 Oct 29.
PubMed 21076589Chen J, Chen L, Wu L, Wang R, Liu JB, Hu B, Jiang LX. Value of superb microvascular imaging ultrasonography in the diagnosis of carpal tunnel syndrome: Compared with color Doppler and power Doppler. Medicine (Baltimore). 2017 May;96(21):e6862. doi: 10.1097/MD.0000000000006862.
PubMed 28538376
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superb Microvascular Imaging of Median Nerve in Carpal Tunnel Syndrome: A Novel Technique in Diagnostic Ultrasound
- ClinicalTrials.gov ID
- NCT03213847
- Acronym / sponsor ID
- SMI001
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Keywords
- Carpal Tunnel Syndrome, Superb microvascular imaging, Doppler ultrasound, Ultrasound, Median Nerve Entrapment, Diagnoses Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 25 Nov 2017 (actual)
- First posted
- 11 Jul 2017 (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.
The aim of the study was to determine whether there is a correlation between the increased intraneural flow as measured using Doppler ultrasound (US) and superb microvascular imaging (SMI) methods and the severity of CTS as measured by nerve conduction studies. Moreover, investigators investigated the association of increased intraneural flow with the cross sectional area of the median nerve. The null hypothesis that there is no correlation between increased intraneural flow and the severity of carpal tunnel syndrome.
Detailed description
Thanks to ultrasound (US) has a low cost, portable, available and non-invasive, the use of diagnostic US in musculoskeletal diseases is rapidly growing in worldwide. Because it is easy to identify the limb structures such as muscle, tendon, and nerves and also, their pathologies, US is frequently used by physiatrists, orthopedics, rheumatologists, sports medicine and pain management physicians nowadays. Providing images of the median nerve (MN) and accompanying structures and give dynamic images about the anatomy of the carpal tunnel are the most superiorities of US in carpal tunnel syndrome (CTS) diagnosis. The diagnose of CTS based on history and physical examination and confirmed with electrodiagnostic studies. Although the specificity of nerve conduction tests is high, there is significant variability in sensitivity (62-85%). Therefore, US has been suggested as an additional or alternative diagnose of CTS. Especially measurement of the cross-sectional area (CSA) of the MN is significantly greater in CTS patients and shows a significant correlation with electrodiagnostic findings such as sensory nerve conduction velocity (SCV) and distal motor latency (DML). Because it enhances the diagnostic accuracy the detection of the epineural or intraneuronal blood flow, the three techniques of Doppler US, are more recently preferred. The contributions of color, power and spectral Doppler techniques in CTS diagnosis, were studied in various studies before. While for the detection of intraneural flow, the power Doppler (PD) seems to be the best way, the specify, sensitivity and diagnostic accuracy of each Doppler techniques were good in most studies.
Superb microvascular imaging (SMI) (Toshiba Medical Systems, Tokyo, Japan) is a new era in diagnostic ultrasound image processing technique. This new technology assigns accurate visualization of vascular structures with intensive clutter suppression to provide flow signals large to small vessels and represent this data at high frame rates. The both of the two modes (color SMI (cSMI) and the monochrome SMI (mSMI)) of the SMI, allows to visualizing lower velocity blood flows and smaller vessels without the use of contrast medium. To the best of our knowledge, there have been no clinical trials which studied of the healthy or injured median nerve blood flow with SMI.
The aim of the study was to compare the diagnostic value of Doppler US and SMI methods in CTS based on detection of increased intraneural flow. Moreover, investigators investigated the association of increased intraneural flow with the CSA of the MN. The null hypothesis that there is no difference between Doppler US and SMI methods in the detection of increased intraneural flow in CTS patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Participants with carpal tunnel syndrome | Other | Device: Superb microvascular imaging (SMI) (Toshiba)Participants diagnosed with carpal tunnel syndrome; will be evaluated with Doppler ultrasound and superb microvascular imaging (SMI) ultrasound. The results of these two evaluations will be compared between each other in according to severity of carpal tunnel syndrome (severity will be determined by electromyography studies) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who diagnosed as as mild, moderate or severe CTS with electromyography
- Age between 18-45
Key exclusion criteria (5 listed)
- History of upper extremity trauma
- Diabetes mellitus
- Pregnancy,
- Rheumatological diseases
- Hypothyroidism
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 |
|---|---|---|
| Superb microvascular imaging (SMI) (Toshiba)to determine whether there is a correlation between the increased intraneural flow as measured using Doppler US and SMI methods and the severity of CTS as measured by nerve conduction studies, we designed this study | Device | Participants with carpal tunnel syndrome |
Primary outcome
Vascular blood flow images from median nerve (enterrapted in carpal tunnel) obtained with Power Doppler and Superb microvascular imaging.
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
Four-stage classify will be use for grading these images; Grade 0: No vascularity in MN, Grade 1: One or two focal color-encoded spots in MN, Grade 2: One linear color-encoded line or more than two focal color-encoded spots in MN, Grade 3: More than one linear color-encoded line in MN
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 28629689Orlandi D, Gitto S, Perugin Bernardi S, Corazza A, De Flaviis L, Silvestri E, Cimmino MA, Sconfienza LM. Advanced Power Doppler Technique Increases Synovial Vascularity Detection in Patients with Rheumatoid Arthritis. Ultrasound Med Biol. 2017 Sep;43(9):1880-1887. doi: 10.1016/j.ultrasmedbio.2017.05.004. Epub 2017 Jun 17.
- Background: PubMed 21076589Akcar N, Ozkan S, Mehmetoglu O, Calisir C, Adapinar B. Value of power Doppler and gray-scale US in the diagnosis of carpal tunnel syndrome: contribution of cross-sectional area just before the tunnel inlet as compared with the cross-sectional area at the tunnel. Korean J Radiol. 2010 Nov-Dec;11(6):632-9. doi: 10.3348/kjr.2010.11.6.632. Epub 2010 Oct 29.
- Background: PubMed 28538376Chen J, Chen L, Wu L, Wang R, Liu JB, Hu B, Jiang LX. Value of superb microvascular imaging ultrasonography in the diagnosis of carpal tunnel syndrome: Compared with color Doppler and power Doppler. Medicine (Baltimore). 2017 May;96(21):e6862. doi: 10.1097/MD.0000000000006862.
- Individual participant dataSharing planned: No. Anthropometric and demographic data included age, weight, height, body mass index (BMI), gender, occupation, medication history and hand dominance. Main outcomes of the study: correlation between the increased intraneural flow as measured using Doppler US and Superb microvascular imaging (SMI) methods.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superb microvascular imaging (SMI) (Toshiba) in people with Carpal Tunnel Syndrome Bilateral, run by Uşak University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular blood flow images from median nerve (enterrapted in carpal tunnel) obtained with Power Doppler and Superb microvascular imaging. (time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic). 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 NCT03213847, which also lists 3 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 25 Oct 2018.