Clinical trial NCT06043141: Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome
Official title: Investigation of the Relationship Between Pain Sensitization and Ultrasonographic and Electrodiagnostic Parameters in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Sensitisation
Carpal Tunnel Syndrome
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CTS

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pressure pian threshold
timeFrame: 3 months
Secondary outcomes:
measure: Central sensitization inventory (CSI)
timeFrame: 3 months
measure: hand grip strength
timeFrame: 3 months
measure: Visual analog scale
timeFrame: 3 months
measure: Upper extremity nerve conduction studies
timeFrame: 3 months
measure: median nerve ultrasound
timeFrame: 3 months
measure: Short form-12
timeFrame: 3 months
measure: Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)
timeFrame: 3 months
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Han Training and Research Hospital
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Emre Ata, Asst.Prof
role: STUDY_CHAIR
References: