Clinical trial NCT06239259: Validity and Reliability of Thai Version Clinical Questionnaire for Diagnosis of Carpal Tunnel Syndrome
Official title: Validity and Reliability of Thai Version of Kamath and Stothard Clinical Questionnaire for Diagnosis of Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Diagnosis
Content validity
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Carpal tunnel syndrome patients who recieved conservative treatment at Single-center, Siriraj hospital, Thailand

Brief summary: The Kamath and Stothard clinical questionnaire for diagnosing carpal tunnel syndrome (CTS) is a valid score for diagnosis of CTS. However it haven't been translated in to Thai version and the validity and accuracy of the Thai the Thai version have not been yet verified.

The research team recognizes the importance and potential benefits of adapting this assessment for use within the Thai population.Therefore, we aim to conduct this research to translate the questionnaire from the original English to Thai and to assess its validity and reliability for diagnosing patients with Carpal Tunnel Syndrome.

Detailed description: Carpal Tunnel Syndrome is a common condition among working and older adults. The incidence of the disease ranges from 7 to 19 percent in the general population, with an approximate rate of 99 cases per 100,000 population per year. Symptoms are typically associated with hand and wrist function. Patients frequently seek medical attention due to numbness or pain in their hands after prolonged, continuous use. Some individuals may experience persistent numbness or pain in their hands, significantly impacting their daily lives. In cases of prolonged symptoms, weakness of the thumb may also occur.

The diagnosis is established through a comprehensive history and physical examination, with symptoms including numbness in the thumb and index finger, as well as the middle finger and the portion of the ring finger adjacent to the middle finger. Some individuals may experience pain, especially at night or in cold conditions, often aggravated by the use of the hands and wrists. The physical examination reveals a reduction in tactile sensations in the regions corresponding to the thumb, index finger, middle finger, and half of the ring finger near the middle finger. In severe cases, weakness of the abductor pollicis brevis muscle or muscle atrophy in the thenar area may be detected. Confirmation of the diagnosis can be achieved through an electrodiagnostic study of muscles and nerves.

Kamath and Stothard clinical questionnaire was developed to help clinician in the diagnosis of CTS, with score more than 5 the diagnosis can be achieve without needed for further electrodiagnostic test. However it haven't been translated in to Thai version and the validity and accuracy of the Thai the Thai version have not been yet verified.

The research team recognizes the importance and potential benefits of adapting this assessment for use within the Thai population.Therefore, we aim to conduct this research to translate the questionnaire from the original English to Thai and to assess its validity and reliability for diagnosing patients with Carpal Tunnel Syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older who are admitted to Siriraj Hospital with signs and symptoms consistent with carpal tunnel disease.
* Diagnosis of carpal tunnel disease was confirm with electrodiagnostic study and electromyography
* Must be able to communicate in Thai.

Exclusion Criteria:

* Patients diagnosed with other neurological diseases such as cerebrovascular disease, cervical radiculopathy, diabetic neuropathy, tumors of the nerve endings in the arm, and other peripheral neuropathy.
* Pregnancy or breastfeeding
* History of recieving chemotheraphy agent
* Patient who recieved surgical treatment for carpal tunnel syndrome.

Primary outcomes:
measure: Validity of Thai version of Kamath and Stothard Questionnaire in carpal tunnel syndrome patients
timeFrame: Pre-treatment
measure: Reliability of Thai version of Kamath and Stothard Questionnaire in carpal tunnel syndrome patients
timeFrame: Pre-treatment and 2 weeks later
Secondary outcomes:
measure: Thai version of Boston carpal tunnel questionnaire (BCTQ)
timeFrame: Pre-treatment
measure: Thai version of EQ-5D-5L questionaire
timeFrame: Pre-treatment
measure: Thai version of Patient-rated wrist evaluation questionaire (PRWE)
timeFrame: Pre-treatment
measure: Thai version of Quick Disabilities of Arm, Shoulder and Hand questionaire (QuickDASH)
timeFrame: Pre-treatment
measure: Thai Language of the Neuropathic Pain Diagnostic Questionnaire (DN4)
timeFrame: Pre-treatment
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
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