Correlation of Different Ultrasonographic Indices With Clinical Parameters in Carpal Tunnel Syndrome

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Recruiting
CT.gov ID
NCT06115187
Collaborator
(none)
50
1
7.7
6.5

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and clinical parameters.

The main questions it aims to answer are:
  • To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the patient's clinical complaints?

  • To what extent are the different ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome correlated with each other?

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nerve ultrasound
  • Diagnostic Test: Nerve conduction studies

Detailed Description

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. 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. In the diagnosis of CTS, the diagnosis is made electrodiagnostically along with typical clinical findings. However, in recent years, ultrasound has become one of the most preferred methods in the diagnosis of CTS because it is non-invasive, rapid and correlates with electrodiagnostic methods. Diameter, cross-sectional area and echogenicity of the median nerve at the carpal tunnel entrance are the most frequently evaluated parameters in ultrasonographic examination. In different studies, it is aimed to increase the power of ultrasonography in the diagnosis of CTS with various indices created in addition to standardized measurements. The most commonly used ultrasonographic indices, which have been shown to be correlated with electrodiagnostic diagnostic methods, are the wrist-forearm median nerve cross-sectional area ratio, the ratio of median nerve cross-sectional area to carpal tunnel area at the carpal tunnel entry level, and echogenicity assessment. Although the relationship of these indexes, which are reported to have sufficient diagnostic sensitivity and specificity, with the patient's clinical complaints is shown on a measurement basis, there is not enough data on the comparison of different formulas and their correlation with the patient's clinical complaints, including neuropathic pain.Based on this, this study aimed to investigate the relationship between ultrasonographic indices used in patients diagnosed with CTS and clinical parameters.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Correlation of Different Ultrasonographic Indices With Clinical Parameters in Carpal Tunnel Syndrome
Actual Study Start Date :
Oct 10, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patient group

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

Outcome Measures

Primary Outcome Measures

  1. median nerve ultrasound [3 months]

    Median nerve cross-sectional area measurement at the level of the carpal tunnel (mm²)

  2. median nerve ultrasound [3 months]

    Median nerve echogenicity at the level of the carpal tunnel (%)

  3. median nerve ultrasound [3 months]

    Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)

  4. median nerve ultrasound [3 months]

    Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)

  5. median nerve ultrasound [3 months]

    Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)

  6. median nerve ultrasound [3 months]

    vertical thickness measurement of the median nerve at the level of the carpal tunnel

Secondary Outcome Measures

  1. Visual analog scale [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).

  2. Upper extremity nerve conduction studies [3 months]

    Bilateral median and ulnar sensorimotor latency measurement (msec)

  3. Upper extremity nerve conduction studies [3 months]

    Bilateral median and ulnar motor amplitude measurement (mV)

  4. Upper extremity nerve conduction studies [3 months]

    Bilateral median and ulnar sensory amplitude measurement ( µV)

  5. Upper extremity nerve conduction studies [3 months]

    Bilateral median and ulnar sensorimotor conduction velocity measurement (m/sn)

  6. Self Leeds Assessment of Neuropathic Symptoms and Sign [3 months]

    Self Leeds Assessment of Neuropathic Symptoms and Sign 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.The total score ranges from 0 to 24, and higher scores are associated with an increase in neuropathic complaints.

  7. Boston Carpal Tunnel Questionnaire [3 months]

    he 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); SSS score range is 11-55, FSS score range is 8-40 and higher scores indicate worse symptoms or function.

  8. hand grip strength [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saglik Bilimleri Universitesi Istanbul Uskudar Turkey

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Study Chair: Emre Ata, Assoc.Prof, Saglik Bilimleri Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Feyza Nur Yucel, Specialist, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT06115187
Other Study ID Numbers:
  • 23-516
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Feyza Nur Yucel, Specialist, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023