Carpal Tunnel Syndrome (CTS)NCT07170449
Investigation of the Relationship Between Ultrasonographic Parameters and Tactile Sensation in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS), run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and the level of tactile sensation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Nerve conduction studies, Median nerve ultrasonography and Sensory testing
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 30 Apr 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed CTS
Who may be able to join
- Electrodiagnostic diagnosis of carpal tunnel syndrome with pain, numbness, burning, and tingling consistent with the median nerve dermatomal area lasting at least 6 weeks.
- Literate
- Agree to participate in the study
Who cannot join
- Concomitant diabetes, systemic inflammatory disease, active infection, and history of malignancy
- Being <18 and >65 years old
- Being illiterate
- Refusing to participate in the study
- Having a disease with neuropathic pain, such as polyneuropathy, radiculopathy, or MS
- Other concomitant upper extremity entrapment neuropathies (e.g., cubital tunnel syndrome)
- Having undergone surgery for carpal tunnel syndrome
- Rheumatoid arthritis, advanced hand osteoarthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamit Han Trainin and Educational Hospital
Üsküdar, İ̇stanbul
Müyesser Cavlak, PhD, +905426406118, muyessercavlak@hotmail.com
About this study
The aim of this study was to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and the level of tactile sensation.
The primary questions the study aimed to answer are:
- To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the level of sensory complaints in the patient?
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The etiology of CTS can be related to work, lifestyle, injury, or genetic predisposition. Exposure to vibrations or repetitive forceful angular movements is among the most common causes of CTS. Certain diseases, such as diabetes, pregnancy, and morbidity, are also thought to be associated with an increased risk of developing CTS. It accounts for 90% of all entrapment neuropathies. Its prevalence in the population is between 1% and 5%, and it is three times more common in women. In CTS, complaints related to motor and sensory deficits are observed in the first three fingers innervated by the median nerve and the radial aspect of the fourth finger. Diagnosis is made by corroborating clinical signs and symptoms with electrophysiological findings. However, recently, ultrasound (US) is frequently preferred for the diagnosis of CTS to evaluate the morphological and mechanical properties of the median nerve. US is considered a highly accurate, effective, and cost-effective diagnostic method for the diagnosis of CTS, with a short evaluation time . Sonographic measurements related to CTS can yield values such as the diameter of the nerve at the entrance and exit of the tunnel. CTS presents with a disturbance in tactile input, such as numbness and loss of sensation in the median nerve dermatom. This sensory loss can cause difficulty in using the patient's hand in activities of daily living. Sonography has recently become widely used in CTS patients. The fact that values measured by sonography can provide information about the clinical status of patients can be considered important data for healthcare professionals. Therefore, our study was designed to examine the relationship between sonographic measurements and tactile sensory levels in patients diagnosed with mild to moderate CTS based on electrodiagnostic tests.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Nerve conduction studies, Median nerve ultrasonography, Sensory testing
- Keywords
- Carpal Tunnel Syndrome, Ultrasonography, Tactile Sensation
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve conduction studiesDiagnostic test
Upper extremity nerve conduction studies including median-ulnar sensory and motor responses
Median nerve ultrasonographyDiagnostic test
Median nerve sonographic cross-sectional area and echogenicity measurements
Sensory testingDiagnostic test
tactile sensory tests
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients with carpal tunnel syndrome Receives: Diagnostic Test: Nerve conduction studies; Diagnostic Test: Median nerve ultrasonography; Diagnostic Test: Sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
median nerve ultrasound
Median nerve maximum cross-sectional area measurement at the level of the carpal tunnel (mm²)
Measured: 3 Months
Pointed - blunt discrimination test
The patient is asked to distinguish between a pointed and a blunt tip by touching the median nerve dermatome.
Measured: 3 Months
Moved two point discrimination
The patient's finger is touched, starting from the distal tip and moving proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in mm.
Measured: 3 months
Fixed Two Point Discrimination Test
The patient's finger is touched starting from the distal tip and working proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in millimeters.
Measured: 3 months
Semmes Weinstein Test
With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.
Measured: 3 months
median nerve ultrasound
Median nerve echogenicity at the level of the carpal tunnel (%)
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)
Measured: 3 months
Secondary outcomes (3)
Boston Carpal Tunnel Syndrome Questionnaire
The scale consists of an 11-question Likert-style symptom severity scale and an 8-question functional status scale. The total score is divided by the number of questions to calculate the score. Higher scores are associated with increased symptom severity and poorer functional status.
Measured: 3 Months
S-LANSS
A score of 12 or more out of 24 on a 7-question scale is considered in favor of neuropathic pain.
Measured: 3 Months
SF-12 (Short Form-12)
The SF-12 is a practical test consisting of seven questions that examine the life limits of the patient. The questionnaire includes questions aimed at understanding the physical and psychiatric effects. The results of the survey are calculated using two score calculation tools: physical (PCS-12) and mental (MCS-12). The highest score for the PCS-12 is 56.6, while the highest score for the MCS-12 is 60.7. Higher scores are comparable to a state of resilience and recovery, which can be compared to quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Müyesser Cavlak, PhD, Principal investigator, Sultan Abdülhamit Han Trainin and Educatioal HospitalEmre Ata, Assoc Prof, Study chair, Sultan Abdülhamit Han Trainin and Educatioal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170449
- Sponsor's protocol ID
- Sultan Abdulhamid Han
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
PubMed 15772908Sezgin M, Incel NA, Serhan S, Camdeviren H, As I, Erdogan C. Assessment of symptom severity and functional status in patients with carpal tunnel syndrome: reliability and functionality of the Turkish version of the Boston Questionnaire. Disabil Rehabil. 2006 Oct 30;28(20):1281-5. doi: 10.1080/09638280600621469.
PubMed 17083175Multanen J, Ylinen J, Karjalainen T, Ikonen J, Hakkinen A, Repo JP. Structural validity of the Boston Carpal Tunnel Questionnaire and its short version, the 6-Item CTS symptoms scale: a Rasch analysis one year after surgery. BMC Musculoskelet Disord. 2020 Sep 12;21(1):609. doi: 10.1186/s12891-020-03626-2.
PubMed 32919457Stevens JC. AAEE minimonograph #26: The electrodiagnosis of carpal tunnel syndrome. Muscle Nerve. 1987 Feb;10(2):99-113. doi: 10.1002/mus.880100202.
PubMed 3821791Fisse AL, Pitarokoili K, Motte J, Gamber D, Kerasnoudis A, Gold R, Yoon MS. Nerve echogenicity and intranerve CSA variability in high-resolution nerve ultrasound (HRUS) in chronic inflammatory demyelinating polyneuropathy (CIDP). J Neurol. 2019 Feb;266(2):468-475. doi: 10.1007/s00415-018-9158-3. Epub 2018 Dec 15.
PubMed 30554264Wolny T, Linek P. Reliability of two-point discrimination test in carpal tunnel syndrome patients. Physiother Theory Pract. 2019 Apr;35(4):348-354. doi: 10.1080/09593985.2018.1443358. Epub 2018 Feb 26.
PubMed 29482409Kim JM, Kim MW, Ko YJ. Correlating ultrasound findings of carpal tunnel syndrome with nerve conduction studies. Muscle Nerve. 2013 Dec;48(6):905-10. doi: 10.1002/mus.23841. Epub 2013 Sep 11.
PubMed 23512486Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.
PubMed 25630774Yucel H. Factors affecting symptoms and functionality of patients with carpal tunnel syndrome: a retrospective study. J Phys Ther Sci. 2015 Apr;27(4):1097-101. doi: 10.1589/jpts.27.1097. Epub 2015 Apr 30.
PubMed 25995565
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Ultrasonographic Parameters and Tactile Sensation in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07170449
- Acronym / sponsor ID
- Sultan Abdulhamid Han
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal Tunnel Syndrome, Ultrasonography, Tactile Sensation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 Sep 2025 (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 this study was to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and the level of tactile sensation.
The primary questions the study aimed to answer are:
- To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the level of sensory complaints in the patient?
Detailed description
Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The etiology of CTS can be related to work, lifestyle, injury, or genetic predisposition. Exposure to vibrations or repetitive forceful angular movements is among the most common causes of CTS. Certain diseases, such as diabetes, pregnancy, and morbidity, are also thought to be associated with an increased risk of developing CTS. It accounts for 90% of all entrapment neuropathies. Its prevalence in the population is between 1% and 5%, and it is three times more common in women. In CTS, complaints related to motor and sensory deficits are observed in the first three fingers innervated by the median nerve and the radial aspect of the fourth finger. Diagnosis is made by corroborating clinical signs and symptoms with electrophysiological findings. However, recently, ultrasound (US) is frequently preferred for the diagnosis of CTS to evaluate the morphological and mechanical properties of the median nerve. US is considered a highly accurate, effective, and cost-effective diagnostic method for the diagnosis of CTS, with a short evaluation time . Sonographic measurements related to CTS can yield values such as the diameter of the nerve at the entrance and exit of the tunnel. CTS presents with a disturbance in tactile input, such as numbness and loss of sensation in the median nerve dermatom. This sensory loss can cause difficulty in using the patient's hand in activities of daily living. Sonography has recently become widely used in CTS patients. The fact that values measured by sonography can provide information about the clinical status of patients can be considered important data for healthcare professionals. Therefore, our study was designed to examine the relationship between sonographic measurements and tactile sensory levels in patients diagnosed with mild to moderate CTS based on electrodiagnostic tests.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: Nerve conduction studies, Diagnostic Test: Median nerve ultrasonography, Diagnostic Test: Sensory testingPatients with carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed CTS
Key inclusion criteria (3 listed)
- Electrodiagnostic diagnosis of carpal tunnel syndrome with pain, numbness, burning, and tingling consistent with the median nerve dermatomal area lasting at least 6 weeks.
- Literate
- Agree to participate in the study
Key exclusion criteria (8 listed)
- Concomitant diabetes, systemic inflammatory disease, active infection, and history of malignancy
- Being <18 and >65 years old
- Being illiterate
- Refusing to participate in the study
- Having a disease with neuropathic pain, such as polyneuropathy, radiculopathy, or MS
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 |
|---|---|---|
| Nerve conduction studiesUpper extremity nerve conduction studies including median-ulnar sensory and motor responses | Diagnostic test | Patient group |
| Median nerve ultrasonographyMedian nerve sonographic cross-sectional area and echogenicity measurements | Diagnostic test | Patient group |
| Sensory testingtactile sensory tests | Diagnostic test | Patient group |
Primary outcome
median nerve ultrasound
Time frame: 3 Months
Median nerve maximum cross-sectional area measurement at the level of the carpal tunnel (mm²)
Pointed - blunt discrimination test
Time frame: 3 Months
The patient is asked to distinguish between a pointed and a blunt tip by touching the median nerve dermatome.
Moved two point discrimination
Time frame: 3 months
The patient's finger is touched, starting from the distal tip and moving proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in mm.
Fixed Two Point Discrimination Test
Time frame: 3 months
The patient's finger is touched starting from the distal tip and working proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in millimeters.
Semmes Weinstein Test
Time frame: 3 months
With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.
median nerve ultrasound
Time frame: 3 months
Median nerve echogenicity at the level of the carpal tunnel (%)
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)
3 secondary outcomes
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: 3 Months
S-LANSS
Time frame: 3 Months
SF-12 (Short Form-12)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 15772908Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
- Background: PubMed 17083175Sezgin M, Incel NA, Serhan S, Camdeviren H, As I, Erdogan C. Assessment of symptom severity and functional status in patients with carpal tunnel syndrome: reliability and functionality of the Turkish version of the Boston Questionnaire. Disabil Rehabil. 2006 Oct 30;28(20):1281-5. doi: 10.1080/09638280600621469.
- Background: PubMed 32919457Multanen J, Ylinen J, Karjalainen T, Ikonen J, Hakkinen A, Repo JP. Structural validity of the Boston Carpal Tunnel Questionnaire and its short version, the 6-Item CTS symptoms scale: a Rasch analysis one year after surgery. BMC Musculoskelet Disord. 2020 Sep 12;21(1):609. doi: 10.1186/s12891-020-03626-2.
- Background: PubMed 3821791Stevens JC. AAEE minimonograph #26: The electrodiagnosis of carpal tunnel syndrome. Muscle Nerve. 1987 Feb;10(2):99-113. doi: 10.1002/mus.880100202.
- Background: PubMed 30554264Fisse AL, Pitarokoili K, Motte J, Gamber D, Kerasnoudis A, Gold R, Yoon MS. Nerve echogenicity and intranerve CSA variability in high-resolution nerve ultrasound (HRUS) in chronic inflammatory demyelinating polyneuropathy (CIDP). J Neurol. 2019 Feb;266(2):468-475. doi: 10.1007/s00415-018-9158-3. Epub 2018 Dec 15.
- Background: PubMed 29482409Wolny T, Linek P. Reliability of two-point discrimination test in carpal tunnel syndrome patients. Physiother Theory Pract. 2019 Apr;35(4):348-354. doi: 10.1080/09593985.2018.1443358. Epub 2018 Feb 26.
- Background: PubMed 23512486Kim JM, Kim MW, Ko YJ. Correlating ultrasound findings of carpal tunnel syndrome with nerve conduction studies. Muscle Nerve. 2013 Dec;48(6):905-10. doi: 10.1002/mus.23841. Epub 2013 Sep 11.
- Background: PubMed 25630774Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.
- Background: PubMed 25995565Yucel H. Factors affecting symptoms and functionality of patients with carpal tunnel syndrome: a retrospective study. J Phys Ther Sci. 2015 Apr;27(4):1097-101. doi: 10.1589/jpts.27.1097. Epub 2015 Apr 30.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome (CTS)
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Müyesser Cavlak, PhD principal investigator
Sultan Abdülhamit Han Trainin and Educatioal Hospital
Emre Ata, Assoc Prof study chair
Sultan Abdülhamit Han Trainin and Educatioal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS), run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Müyesser Cavlak, PhD (+905426406118, muyessercavlak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median nerve ultrasound (time frame: 3 Months). The study lists 9 primary outcomes in all. 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 NCT07170449, which also lists 9 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 12 Sep 2025.