Clinical trial NCT05556278: Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
Official title: Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
nerve conduction study
ultrasound
screening
diagnosis
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical suspicion of CTS that come consecutively from the Neurophysiology Department of the Virgen Macarena Hospital in Seville (Spain).

Brief summary: The main objective is to investigate the value of ultrasound in the diagnosis of Carpal Tunnel Syndrome (CTS), and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values that determine the presence or absence of CTS. Finally, cost-effectiveness analysis is proposed.

Detailed description: The reference test with which the ultrasound is compared is the neurophysiological test (NPT).

The expected timeline for the study is to be performed between July 2020 and May 2023.

Eligibility criteria: Inclusion Criteria:

1. Presenting clinical symptoms suggestive of CTS, at least one of the following:

   * Neuropathic profile pain in wrist-hand at the level of the median nerve territory (wrist, first-second-third, and radial half of the fourth finger by palmar and/or volar side), possibility of irradiation of the pain towards the forearm and/or arm.
   * Nocturnal symptoms.
   * Hypotrophy or atrophy of the thenar eminence.
   * Self-described sensory alteration (sensation of cramping, numbness, tingling, hypoalgesia or analgesia).
2. Age: 18 to 75 years.
3. Consent to participate in the study.

Exclusion Criteria:

1. Previous surgery on the wrist
2. Acquired or hereditary pathology causing peripheral neuropathies
3. Polyneuropathy of any etiology
4. Rheumatoid arthritis
5. Diabetes Mellitus

Primary outcomes:
measure: Demographic variables
timeFrame: January 2021 to September 2022
measure: Electrodiagnostic variables
timeFrame: January 2021 to September 2022
measure: Ultrasound variables
timeFrame: January 2021 to September 2022
measure: Boston Carpal Tunnel Questionnaire
timeFrame: January 2021 to September 2022
measure: Cost evaluation
timeFrame: From September 2022 to May 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
Study officials:
References:
citation: American Association of Electrodiagnostic Medicine, American Academy of Neurology, and American Academy of Physical Medicine and Rehabilitation. Practice parameter for electrodiagnostic studies in carpal tunnel syndrome: summary statement. Muscle Nerve. 2002 Jun;25(6):918-22. doi: 10.1002/mus.10185. No abstract available.
citation: Chen YT, Williams L, Zak MJ, Fredericson M. Review of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and a Proposed Scanning Protocol. J Ultrasound Med. 2016 Nov;35(11):2311-2324. doi: 10.7863/ultra.15.12014. Epub 2016 Sep 14.