Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome

September 5, 2025 updated by: Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Feyza Nur Yücel, Specialist
  • Phone Number: 90 5385577059
  • Email: dr.fny28@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye)
        • Sultan Abdulhamid Han Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with CTS

Description

Inclusion Criteria:

  • Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
  • Agreeing to participate in the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
Healthy control
Diagnostic test: Nerve ultrasound
Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels
Diagnostic test: Pressure pain threshold
Pain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity.
Other Names:
  • PPT
Patients with carpal tunnel syndrome
Diagnostic test: Nerve ultrasound
Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels
Diagnostic test: Nerve conduction studies
Upper extremity nerve conduction studies including median-ulnar sensory and motor responses
Diagnostic test: Pressure pain threshold
Pain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity.
Other Names:
  • PPT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: 3 months
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
3 months
hand grip strength
Time Frame: 3 months
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.
3 months
Central sensitization inventory (CSI)
Time Frame: 3 months
Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.
3 months
Upper extremity nerve conduction studies
Time Frame: 3 months
Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.
3 months
median nerve ultrasound
Time Frame: 3 months
Median nerve cross-sectional area and echogenicity measurement
3 months
Short form-12
Time Frame: 3 months
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.
3 months
Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)
Time Frame: 3 months
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.
3 months
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Emre Ata, Asst.Prof, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Dataset sharing is not planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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