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Recruiting NCT07170449

Investigation of the Relationship Between Ultrasonographic Parameters and Tactile Sensation in Carpal Tunnel Syndrome

— Observational Carpal Tunnel Syndrome (CTS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerve conduction studies, Median nerve ultrasonography, Sensory testing.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome (CTS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The aim of this study was to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and the level of tactile sensation. The primary questions the study aimed to answer are: • To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the level of sensory complaints in the patient?

Detailed description

Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The etiology of CTS can be related to work, lifestyle, injury, or genetic predisposition. Exposure to vibrations or repetitive forceful angular movements is among the most common causes of CTS. Certain diseases, such as diabetes, pregnancy, and morbidity, are also thought to be associated with an increased risk of developing CTS. It accounts for 90% of all entrapment neuropathies. Its prevalence in the population is between 1% and 5%, and it is three times more common in women. In CTS, complaints related to motor and sensory deficits are observed in the first three fingers innervated by the median nerve and the radial aspect of the fourth finger. Diagnosis is made by corroborating clinical signs and symptoms with electrophysiological findings. However, recently, ultrasound (US) is frequently preferred for the diagnosis of CTS to evaluate the morphological and mechanical properties of the median nerve. US is considered a highly accurate, effective, and cost-effective diagnostic method for the diagnosis of CTS, with a short evaluation time . Sonographic measurements related to CTS can yield values such as the diameter of the nerve at the entrance and exit of the tunnel. CTS presents with a disturbance in tactile input, such as numbness and loss of sensation in the median nerve dermatom. This sensory loss can cause difficulty in using the patient's hand in activities of daily living. Sonography has recently become widely used in CTS patients. The fact that values measured by sonography can provide information about the clinical status of patients can be considered important data for healthcare professionals. Therefore, our study was designed to examine the relationship between sonographic measurements and tactile sensory levels in patients diagnosed with mild to moderate CTS based on electrodiagnostic tests.

Interventions

  • Diagnostic test Nerve conduction studies
    Upper extremity nerve conduction studies including median-ulnar sensory and motor responses
  • Diagnostic test Median nerve ultrasonography
    Median nerve sonographic cross-sectional area and echogenicity measurements
  • Diagnostic test Sensory testing
    tactile sensory tests

Primary outcome measures

  • median nerve ultrasound [Time frame: 3 Months]
  • Pointed - blunt discrimination test [Time frame: 3 Months]
  • Moved two point discrimination [Time frame: 3 months]
  • Fixed Two Point Discrimination Test [Time frame: 3 months]
  • Semmes Weinstein Test [Time frame: 3 months]
  • median nerve ultrasound [Time frame: 3 months]
  • median nerve ultrasound [Time frame: 3 months]
  • median nerve ultrasound [Time frame: 3 months]
  • median nerve ultrasound [Time frame: 3 months]
Secondary outcome measures (3)
  • Boston Carpal Tunnel Syndrome Questionnaire [Time frame: 3 Months]
  • S-LANSS [Time frame: 3 Months]
  • SF-12 (Short Form-12) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Electrodiagnostic diagnosis of carpal tunnel syndrome with pain, numbness, burning, and tingling consistent with the median nerve dermatomal area lasting at least 6 weeks.
  • Literate
  • Agree to participate in the study

Exclusion criteria

  • Concomitant diabetes, systemic inflammatory disease, active infection, and history of malignancy
  • Being <18 and >65 years old
  • Being illiterate
  • Refusing to participate in the study
  • Having a disease with neuropathic pain, such as polyneuropathy, radiculopathy, or MS
  • Other concomitant upper extremity entrapment neuropathies (e.g., cubital tunnel syndrome)
  • Having undergone surgery for carpal tunnel syndrome
  • Rheumatoid arthritis, advanced hand osteoarthritis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Sultan Abdülhamit Han Trainin and Educational Hospital — Üsküdar

Publications

  • Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007. PMID 15772908
  • Sezgin M, Incel NA, Serhan S, Camdeviren H, As I, Erdogan C. Assessment of symptom severity and functional status in patients with carpal tunnel syndrome: reliability and functionality of the Turkish version of the Boston Questionnaire. Disabil Rehabil. 2006 Oct 30;28(20):1281-5. doi: 10.1080/09638280600621469. PMID 17083175
  • Multanen J, Ylinen J, Karjalainen T, Ikonen J, Hakkinen A, Repo JP. Structural validity of the Boston Carpal Tunnel Questionnaire and its short version, the 6-Item CTS symptoms scale: a Rasch analysis one year after surgery. BMC Musculoskelet Disord. 2020 Sep 12;21(1):609. doi: 10.1186/s12891-020-03626-2. PMID 32919457
  • Stevens JC. AAEE minimonograph #26: The electrodiagnosis of carpal tunnel syndrome. Muscle Nerve. 1987 Feb;10(2):99-113. doi: 10.1002/mus.880100202. PMID 3821791
  • Fisse AL, Pitarokoili K, Motte J, Gamber D, Kerasnoudis A, Gold R, Yoon MS. Nerve echogenicity and intranerve CSA variability in high-resolution nerve ultrasound (HRUS) in chronic inflammatory demyelinating polyneuropathy (CIDP). J Neurol. 2019 Feb;266(2):468-475. doi: 10.1007/s00415-018-9158-3. Epub 2018 Dec 15. PMID 30554264
  • Wolny T, Linek P. Reliability of two-point discrimination test in carpal tunnel syndrome patients. Physiother Theory Pract. 2019 Apr;35(4):348-354. doi: 10.1080/09593985.2018.1443358. Epub 2018 Feb 26. PMID 29482409
  • Kim JM, Kim MW, Ko YJ. Correlating ultrasound findings of carpal tunnel syndrome with nerve conduction studies. Muscle Nerve. 2013 Dec;48(6):905-10. doi: 10.1002/mus.23841. Epub 2013 Sep 11. PMID 23512486
  • Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9. PMID 25630774

Identifiers

NCT: NCT07170449 · Sultan Abdulhamid Han

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗