Carpal Tunnel SyndromeNCT07114913
Symptom Distribution and Pain Sensitization in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome and Central Sensitisation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare central sensitization parameters between carpal tunnel syndrome (CTS) patients with extra median symptom distribution and those with typical, median nerve-related symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Central Sensitisation, Pain, Radiating
- What is being tested?
- Nerve ultrasound, Nerve conduction studies and Pressure pain threshold
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2025to 1 Mar 2026
- 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
- Adult, Older adult
Study population: Patients with CTS
Who may be able to join
- Having been diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
- Being between 18 and 65 years of age
- Being literate
- Agreeing to participate in the study
Who cannot join
- Having a history of concomitant diabetes, systemic inflammatory disease, active infection, or malignancy
- Being <18 and >65 years of age
- Being illiterate
- Refusing to participate in the study
- Having a disease associated with neuropathic pain, such as polyneuropathy, radiculopathy, or multiple sclerosis
- History of injection or surgery for CTS within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emre Ata, Assoc. Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Usküdar, 34100
Feyza Nur Yücel, Specialist
(0216) 542 20 00 ext. 90
About this study
Official title: Evaluation of Central Sensitization Parameters Based on Extra Median Symptom Distribution in Carpal Tunnel Syndrome: A Cross-sectional Study
This study aims to compare central sensitization parameters between carpal tunnel syndrome (CTS) patients with extra median symptom distribution and those with typical, median nerve-related symptoms. Extra median sensory spread, observed in some CTS patients beyond the anatomical boundaries of the median nerve, may reflect central sensitization mechanisms. Using the Central Sensitization Inventory and pressure pain threshold measurements, this study will assess whether extra median symptom patterns are associated with increased central sensitization.
Read the detailed description
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically presenting with numbness and tingling in the thumb, index, and middle fingers due to median nerve compression at the wrist. However, some patients report symptom spread beyond the median nerve distribution, involving ulnar regions of the hand, forearm, shoulder, or even scapular areas. This phenomenon, known as extra median symptom distribution, has been increasingly associated with central sensitization (CS).This study aims to compare central sensitization parameters between CTS patients with typical symptoms and those showing extra median spread. Pressure pain threshold (PPT) and Central Sensitization Inventory (CSI) scores will be used to evaluate sensitization levels. The initial hypothesis of this study was that patients with extra-median symptoms would exhibit lower PPT values and higher CSI scores, indicating greater central sensitivity. Findings may highlight the need to consider central mechanisms in CTS management and promote more personalized treatment approaches.
- Being tested
- Nerve ultrasound, Nerve conduction studies, Pressure pain threshold
- Keywords
- carpal tunnel syndrome, central sensitization, central sensitization inventory, pressure pain threshold
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve ultrasoundDiagnostic test
Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels
Nerve conduction studiesDiagnostic test
Upper extremity nerve conduction studies including median-ulnar sensory and motor responses
Pressure pain thresholdDiagnostic test
Pain pressure threshold is used to measure deep muscular tissue pain sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with Carpal Tunnel Syndrome Receives: Diagnostic Test: Nerve ultrasound; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Pressure pain threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.
Measured: 3 months
Katz hand diagram
The Katz Hand Diagram is a self-reported symptom map used to support the diagnosis of Carpal Tunnel Syndrome (CTS). Patients are asked to mark areas on a standardized hand diagram where they experience pain, numbness, or tingling. This tool helps clinicians assess whether symptoms follow a median nerve distribution and is commonly used in both clinical and research settings due to its simplicity and diagnostic value.
Measured: 3 months
Secondary outcomes (12)
Central sensitization inventory (CSI)
Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis. The score range is between 0 and 100, and as the score increases, the severity of sensitization symptoms increases.
Measured: 3 months
Visual analog scale
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Measured: 3 months
hand grip strength
Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.
Measured: 3 months
Median nerve conduction studies-latency measurement
Latency values obtained in bilateral median motor and sensory nerve conduction studies.
Measured: 3 months
Median nerve motor conduction studies-amplitude measurement
Amplitude values obtained in bilateral median motor nerve conduction studies.
Measured: 3 months
Median nerve sensory conduction studies-amplitude measurement
Amplitude values obtained in bilateral median sensory nerve conduction studies.
Measured: 3 months
Median nerve conduction studies- conduction velocity measurement
Conduction velocity values obtained in bilateral median motor and sensory nerve conduction studies.
Measured: 3 months
Median nerve ultrasound cross-sectional area measurement
Median nerve cross-sectional area and echogenicity measurement
Measured: 3 months
Median nerve ultrasound echogenicity measurement
Median nerve echogenicity measurement
Measured: 3 months
Short form-12
The 12-item Short Form Questionnaire (SF-12) is used for objective measurement of quality of life. The SF-12 provides two norm-based summary scores-Physical (PCS) and Mental (MCS)-each ranging from 0 to 100. Higher scores indicate better health, with 50 as the average based on U.S. norms.
Measured: 3 months
Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)
S-LANSS is a 7-question scale used to define pain of neuropathic origin. The score range is between 0-24 and a score of 12 points or more is in favor of the presence of neuropathic pain.
Measured: 3 months
Boston Carpal Tunnel Questionnaire (BCTQ)
The Boston Carpal Tunnel Questionnaire (BCTQ) includes two subscales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 items, each scored from 1 (no symptoms) to 5 (very severe symptoms), resulting in a total score range of 11 to 55 and an average score range of 1.0 to 5.0. The FSS contains 8 items, also scored from 1 (no difficulty) to 5 (unable to perform), yielding a total score range of 8 to 40 and an average score range of 1.0 to 5.0. Higher scores on both subscales indicate greater symptom severity or functional limitation.
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 posted11 Aug 2025
- Study start21 Jun 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (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 Carpal Tunnel SyndromeStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emre Ata, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114913
- Sponsor's protocol ID
- 25/603
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing not planned
Publications
Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.
PubMed 25630774Zanette G, Cacciatori C, Tamburin S. Central sensitization in carpal tunnel syndrome with extraterritorial spread of sensory symptoms. Pain. 2010 Feb;148(2):227-236. doi: 10.1016/j.pain.2009.10.025. Epub 2009 Dec 8.
PubMed 20004060Sobeeh MG, Ghozy S, Elshazli RM, Landry M. Pain mechanisms in carpal tunnel syndrome: a systematic review and meta-analysis of quantitative sensory testing outcomes. Pain. 2022 Oct 1;163(10):e1054-e1094. doi: 10.1097/j.pain.0000000000002566. Epub 2021 Dec 15.
PubMed 35050958Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
PubMed 20961685Fernandez-de-las-Penas C, de la Llave-Rincon AI, Fernandez-Carnero J, Cuadrado ML, Arendt-Nielsen L, Pareja JA. Bilateral widespread mechanical pain sensitivity in carpal tunnel syndrome: evidence of central processing in unilateral neuropathy. Brain. 2009 Jun;132(Pt 6):1472-9. doi: 10.1093/brain/awp050. Epub 2009 Mar 31.
PubMed 19336461Feng B, Gong C, You L, Lin Y, Wang Y, Ip WY, Wang Y. Central Sensitization in Patients with Chronic Pain Secondary to Carpal Tunnel Syndrome and Determinants. J Pain Res. 2023 Dec 19;16:4353-4366. doi: 10.2147/JPR.S441786. eCollection 2023.
PubMed 38145037
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Central Sensitization Parameters Based on Extra Median Symptom Distribution in Carpal Tunnel Syndrome: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07114913
- Acronym / sponsor ID
- 25/603
- Keywords
- carpal tunnel syndrome, central sensitization, central sensitization inventory, pressure pain threshold
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Aug 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.
This study aims to compare central sensitization parameters between carpal tunnel syndrome (CTS) patients with extra median symptom distribution and those with typical, median nerve-related symptoms. Extra median sensory spread, observed in some CTS patients beyond the anatomical boundaries of the median nerve, may reflect central sensitization mechanisms. Using the Central Sensitization Inventory and pressure pain threshold measurements, this study will assess whether extra median symptom patterns are associated with increased central sensitization.
Detailed description
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically presenting with numbness and tingling in the thumb, index, and middle fingers due to median nerve compression at the wrist. However, some patients report symptom spread beyond the median nerve distribution, involving ulnar regions of the hand, forearm, shoulder, or even scapular areas. This phenomenon, known as extra median symptom distribution, has been increasingly associated with central sensitization (CS).This study aims to compare central sensitization parameters between CTS patients with typical symptoms and those showing extra median spread. Pressure pain threshold (PPT) and Central Sensitization Inventory (CSI) scores will be used to evaluate sensitization levels. The initial hypothesis of this study was that patients with extra-median symptoms would exhibit lower PPT values and higher CSI scores, indicating greater central sensitivity. Findings may highlight the need to consider central mechanisms in CTS management and promote more personalized treatment approaches.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Nerve ultrasound, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Pressure pain thresholdPatients with Carpal Tunnel Syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with CTS
Key inclusion criteria (4 listed)
- Having been diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
- Being between 18 and 65 years of age
- Being literate
- Agreeing to participate in the study
Key exclusion criteria (6 listed)
- Having a history of concomitant diabetes, systemic inflammatory disease, active infection, or malignancy
- Being <18 and >65 years of age
- Being illiterate
- Refusing to participate in the study
- Having a disease associated with neuropathic pain, such as polyneuropathy, radiculopathy, or multiple sclerosis
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 ultrasoundUltrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels | Diagnostic test | Patients |
| Nerve conduction studiesUpper extremity nerve conduction studies including median-ulnar sensory and motor responses | Diagnostic test | Patients |
| Pressure pain thresholdPain pressure threshold is used to measure deep muscular tissue pain sensitivity. | Diagnostic test | Patients |
Primary outcome
Pressure pain threshold
Time frame: 3 months
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.
Katz hand diagram
Time frame: 3 months
The Katz Hand Diagram is a self-reported symptom map used to support the diagnosis of Carpal Tunnel Syndrome (CTS). Patients are asked to mark areas on a standardized hand diagram where they experience pain, numbness, or tingling. This tool helps clinicians assess whether symptoms follow a median nerve distribution and is commonly used in both clinical and research settings due to its simplicity and diagnostic value.
12 secondary outcomes
Central sensitization inventory (CSI)
Time frame: 3 months
Visual analog scale
Time frame: 3 months
hand grip strength
Time frame: 3 months
Median nerve conduction studies-latency measurement
Time frame: 3 months
Median nerve motor conduction studies-amplitude measurement
Time frame: 3 months
Median nerve sensory conduction studies-amplitude measurement
Time frame: 3 months
Median nerve conduction studies- conduction velocity measurement
Time frame: 3 months
Median nerve ultrasound cross-sectional area measurement
Time frame: 3 months
Median nerve ultrasound echogenicity measurement
Time frame: 3 months
Short form-12
Time frame: 3 months
Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)
Time frame: 3 months
Boston Carpal Tunnel Questionnaire (BCTQ)
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 11 Aug 2025.
- Background: PubMed 25630774Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.
- Background: PubMed 20004060Zanette G, Cacciatori C, Tamburin S. Central sensitization in carpal tunnel syndrome with extraterritorial spread of sensory symptoms. Pain. 2010 Feb;148(2):227-236. doi: 10.1016/j.pain.2009.10.025. Epub 2009 Dec 8.
- Background: PubMed 35050958Sobeeh MG, Ghozy S, Elshazli RM, Landry M. Pain mechanisms in carpal tunnel syndrome: a systematic review and meta-analysis of quantitative sensory testing outcomes. Pain. 2022 Oct 1;163(10):e1054-e1094. doi: 10.1097/j.pain.0000000000002566. Epub 2021 Dec 15.
- Background: PubMed 20961685Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
- Background: PubMed 19336461Fernandez-de-las-Penas C, de la Llave-Rincon AI, Fernandez-Carnero J, Cuadrado ML, Arendt-Nielsen L, Pareja JA. Bilateral widespread mechanical pain sensitivity in carpal tunnel syndrome: evidence of central processing in unilateral neuropathy. Brain. 2009 Jun;132(Pt 6):1472-9. doi: 10.1093/brain/awp050. Epub 2009 Mar 31.
- Background: PubMed 38145037Feng B, Gong C, You L, Lin Y, Wang Y, Ip WY, Wang Y. Central Sensitization in Patients with Chronic Pain Secondary to Carpal Tunnel Syndrome and Determinants. J Pain Res. 2023 Dec 19;16:4353-4366. doi: 10.2147/JPR.S441786. eCollection 2023.
- Individual participant dataSharing planned: No. Data sharing not planned
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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.
Emre Ata, Assoc. Prof contact
Emre Ata study chair
Saglik Bilimleri Universitesi
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 and Central Sensitisation, 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 4 inclusion and 6 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 11 Aug 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 Feyza Nur Yücel, Specialist ((0216) 542 20 00 ext. 90, dr.fny28@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: 3 months). The study lists 2 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 NCT07114913, 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 11 Aug 2025.