Central SensitisationNCT06043141
Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome
An observational study of Central Sensitisation and Carpal Tunnel Syndrome, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational, cross-sectional study is to investigate the relationship between pain sensitization and ultrasonographic and nerve conduction studies in patients diagnosed with carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Sensitisation, Carpal Tunnel Syndrome
- What is being tested?
- Nerve ultrasound, Nerve conduction studies and Pressure pain threshold
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CTS
Who may be able to join
- Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
- Agreeing to participate in the study
Who cannot join
- Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
- Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
- Not agreeing to participate in the study
- History of surgery due to CTS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Uskudar
About this study
Official title: Investigation of the Relationship Between Pain Sensitization and Ultrasonographic and Electrodiagnostic Parameters in Carpal Tunnel Syndrome
The aim of this observational, cross-sectional study is to investigate the relationship between pain sensitization and ultrasonographic and nerve conduction studies in patients diagnosed with carpal tunnel syndrome (CTS).
The main questions it aims to answer are:
- Can threshold values be determined ultrasonographically and electrodiagnostically in patients who develop pain sensitization?
- Are pressure pain threshold values and central sensitization inventory scores correlated with ultrasonographic and nerve conduction studies of the median nerve?
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common nerve entrapment and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. Its incidence varies between 6.3-11.7% in the general population. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. However, it has been reported that these complaints in most patients are not limited to the innervation area of the median nerve but also spread to other neighboring areas. This has been found to be associated with the development of central sensitization in CTS patients, and extra-median symptoms are suggested to be a clinical marker of pain sensitization. The term central sensitization is explained as an increase in pain sensitivity due to the amplification of neuron-derived signals in the central nervous system.Research shows that ongoing damage to the median nerve stimulates neurons located in the central nervous system, advancing the central sensitization process. Although the diagnosis of CTS is made electrodiagnostically with typical clinical findings, in recent years ultrasound has been frequently used in the diagnosis of CTS because it is non-invasive, fast and reliable. Cross-sectional area and echogenicity of the median nerve are the most frequently evaluated parameters at the carpal tunnel with ultrasound. Studies focus on the clinical relationship of central sensitization in CTS, but its relationship with ultrasonographic and electrodiagnostic data is not yet known.Based on this, this study aimed to investigate the relationship between pain sensitization and electrodiagnostic and ultrasonographic parameters in patients diagnosed with CTS.
- Conditions
- Central Sensitisation, Carpal Tunnel Syndrome
- Being tested
- Nerve ultrasound, Nerve conduction studies, Pressure pain threshold
- 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 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
Also called PPT
Pain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with carpal tunnel syndrome | Patients with carpal tunnel syndrome Receives: Diagnostic Test: Nerve ultrasound; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Pressure pain threshold | |
| Control group | Healthy control Receives: Diagnostic Test: Nerve ultrasound; Diagnostic Test: Pressure pain threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pian 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
Secondary outcomes (8)
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.
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
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
Upper extremity nerve conduction studies
Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area and 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. Low scores are associated with poor in quality of life.
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 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 Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Two subscores are calculated: Symptom Severity Scale (SSS) and Functional Status Scale (FSS); higher scores indicate worse symptoms or function.
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 posted21 Sep 2023
- Study start1 Oct 2023
- Primary completion5 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitisationStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Emre Ata, Asst.Prof, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043141
- Sponsor's protocol ID
- 23-517
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dataset sharing is not planned
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 Pain Sensitization and Ultrasonographic and Electrodiagnostic Parameters in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06043141
- Acronym / sponsor ID
- 23-517
- Conditions
- Central Sensitisation, Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 21 Sep 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.
The aim of this observational, cross-sectional study is to investigate the relationship between pain sensitization and ultrasonographic and nerve conduction studies in patients diagnosed with carpal tunnel syndrome (CTS).
The main questions it aims to answer are:
- Can threshold values be determined ultrasonographically and electrodiagnostically in patients who develop pain sensitization?
- Are pressure pain threshold values and central sensitization inventory scores correlated with ultrasonographic and nerve conduction studies of the median nerve?
Detailed description
Carpal tunnel syndrome (CTS) is the most common nerve entrapment and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. Its incidence varies between 6.3-11.7% in the general population. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. However, it has been reported that these complaints in most patients are not limited to the innervation area of the median nerve but also spread to other neighboring areas. This has been found to be associated with the development of central sensitization in CTS patients, and extra-median symptoms are suggested to be a clinical marker of pain sensitization. The term central sensitization is explained as an increase in pain sensitivity due to the amplification of neuron-derived signals in the central nervous system.Research shows that ongoing damage to the median nerve stimulates neurons located in the central nervous system, advancing the central sensitization process. Although the diagnosis of CTS is made electrodiagnostically with typical clinical findings, in recent years ultrasound has been frequently used in the diagnosis of CTS because it is non-invasive, fast and reliable. Cross-sectional area and echogenicity of the median nerve are the most frequently evaluated parameters at the carpal tunnel with ultrasound. Studies focus on the clinical relationship of central sensitization in CTS, but its relationship with ultrasonographic and electrodiagnostic data is not yet known.Based on this, this study aimed to investigate the relationship between pain sensitization and electrodiagnostic and ultrasonographic parameters in patients diagnosed with CTS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with carpal tunnel syndrome | – | Diagnostic Test: Nerve ultrasound, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Pressure pain thresholdPatients with carpal tunnel syndrome |
| Control group | – | Diagnostic Test: Nerve ultrasound, Diagnostic Test: Pressure pain thresholdHealthy control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CTS
Key inclusion criteria (2 listed)
- Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
- Agreeing to participate in the study
Key exclusion criteria (4 listed)
- Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
- Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
- Not agreeing to participate in the study
- History of surgery due to CTS
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 | Control group, Patients with carpal tunnel syndrome |
| Nerve conduction studiesUpper extremity nerve conduction studies including median-ulnar sensory and motor responses | Diagnostic test | Patients with carpal tunnel syndrome |
| Pressure pain thresholdAlso: PPTPain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity. | Diagnostic test | Control group, Patients with carpal tunnel syndrome |
Primary outcome
Pressure pian 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.
8 secondary outcomes
Central sensitization inventory (CSI)
Time frame: 3 months
hand grip strength
Time frame: 3 months
Visual analog scale
Time frame: 3 months
Upper extremity nerve conduction studies
Time frame: 3 months
median nerve ultrasound
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
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 12 Sep 2025.
- Individual participant dataSharing planned: No. Dataset sharing is 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. This study is not recruiting at the moment.
Emre Ata, Asst.Prof 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 Central Sensitisation and Carpal Tunnel Syndrome, 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 2 inclusion and 4 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 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?
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?
Pressure pian threshold (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.