Validity and Reliability of Thai Version of Kamath and Stothard Clinical Questionnaire for Diagnosis of Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Validity and Reliability of Thai Version of Kamath and Stothard Clinical Questionnaire for Diagnosis of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239259
• Other study ID #: 456-2566(IRB4)
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Siriraj Hospital
• Contact: Panai Laohaprasitiporn, M.D.
• Phone: +6624197958
• Email: panai.lao[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Questionare As described in Secondary Outcomes
All patients will recieve Questionare As described in Secondary Outcomes, and will be interviewd by a well-trained reaserch assistanced

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (13)

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Bonett, DG, Wright, TA. Cronbach's alpha reliability: Interval estimation, hypothesis testing, and sample size planning. J Organiz Behav 2015; 36: 3-15.

Chaudakshetrin P, Prateepavanich P, Chira-Adisai W, Tassanawipas W, Leechavengvongs S, Kitisomprayoonkul W. Cross-cultural adaptation to the Thai language of the neuropathic pain diagnostic questionnaire (DN4). J Med Assoc Thai. 2007 Sep;90(9):1860-5. — View Citation

Ferry S, Pritchard T, Keenan J, Croft P, Silman AJ. Estimating the prevalence of delayed median nerve conduction in the general population. Br J Rheumatol. 1998 Jun;37(6):630-5. doi: 10.1093/rheumatology/37.6.630. — View Citation

Kamath V, Stothard J. A clinical questionnaire for the diagnosis of carpal tunnel syndrome. J Hand Surg Br. 2003 Oct;28(5):455-9. doi: 10.1016/s0266-7681(03)00151-7. Erratum In: J Hand Surg [Br]. 2004 Feb;29(1):95. — View Citation

Kimman M, Vathesatogkit P, Woodward M, Tai ES, Thumboo J, Yamwong S, Ratanachaiwong W, Wee HL, Sritara P. Validity of the Thai EQ-5D in an occupational population in Thailand. Qual Life Res. 2013 Aug;22(6):1499-506. doi: 10.1007/s11136-012-0251-2. Epub 20 — View Citation

Laohaprasitiporn P, Monteerarat Y, Jaderojananont W, Limthongthang R, Vathana T. Validity, Reliability and Responsiveness of the Thai Version of Patient-Rated Wrist Evaluation (Th-PRWE) in Distal Radius Fracture Patients. Siriraj Medical Journal. 2021;73(

Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10. — View Citation

Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27. — View Citation

Shoukri MM, Asyali MH, Donner A. Design of reliability study. Statistical Methods in Medical Research 2004; 13: 251-71.

Tongprasert S, Rapipong J, Buntragulpoontawee M. The cross-cultural adaptation of the DASH questionnaire in Thai (DASH-TH). J Hand Ther. 2014 Jan-Mar;27(1):49-54. doi: 10.1016/j.jht.2013.08.020. Epub 2013 Oct 5. — View Citation

Upatham S, Kumnerddee W. Reliability of Thai version Boston questionnaire. J Med Assoc Thai. 2008 Aug;91(8):1250-6. — View Citation

von Schroeder HP, Botte MJ. Carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):643-55. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of Thai version of Kamath and Stothard Quesionaire in carpal tunnel syndrome patients	Compare validity of Thai version of Kamath and Stothard Quesionaire in carpal tunnel syndrome patients with carpal tunnel syndrome	Pre-treatment
Primary	Releability of Thai version of Kamath and Stothard Quesionaire in carpal tunnel syndrome patients	Intraobserver reliability assesment of Thai version of Kamath and Stothard Quesionaire	Pre-treatment, 2wk
Secondary	Thai version of Boston carpal tunnel questionaire (BCTQ)	This questionnaire designed to assess the severity of carpal tunnel syndrome. It consists of two parts: Part 1 involves the evaluation of hand abnormalities, comprising 11 items (symptom severity score). Part 2 assesses the loss of hand function and includes another 8 items (function severity score).	Pre-treatment
Secondary	Thai version of EQ-5D-5L questionaire	This section is Part 1, consisting of 5 questions about supervision, self-care, normal activities, medical/discomfort, and coldness/depression. The questions related to medical/discomfort and coldness/depression have 5 options each, with 2 directly assessing health conditions on a scale from 0 to 100. Here, 0 represents the most adverse change in health, and 100 represents the most positive change in health. The research, particularly, aims to replicate these assessments.	Pre-treatment
Secondary	Thai version of Patient-rated wrist evaluation questionaire (PRWE)	This tool use to assess the functional ability of the wrist. The tool consists of two parts: pain and the ability to perform activities. Part 1 comprises a total of 5 questions, each with multiple-choice answers ranging from 0 to 10 points. A score of 0 indicates no pain, while 10 points indicate the most intense or constant pain. Part 2 includes a total of 10 questions related to daily activities, characterized on a scale from 0 to 10. A score of 0 indicates no interference with daily activities, while 10 points indicate significant interference and limitations in daily living.	Pre-treatment
Secondary	Thai version of Quick Disabilities of Arm, Shoulder and Hand questionaire (QuickDASH)	This assessment that involves inquiring about symptoms and the ability to perform specific activities. The questions are divided into 19 items, categorized into 2 parts: Part 1 assesses the ability to perform certain activities, with scores ranging from 1 (not difficult/no limitations) to 5 (not able to do at all). The second part evaluates the symptoms experienced, using a scale from 1 (no symptoms) to 5 (severe/most severe).	Pre-treatment
Secondary	Thai Language of the Neuropathic Pain Diagnostic Questionnaire (DN4)	This is a 10-item questionnaire designed to detect neuropathic pain has been translated and validated in the Thai version. It consists of 2 parts: a section with patient interview questions comprising 7 yes or no questions. Each 'yes' answer is scored as 1 point. The second part is the physical examination section with 3 questions, and each affirmative finding is scored as 1 point. The test has a total score of 10 points, ranging from 0 to 10. The highest score possible is 10 points, while the lowest score is 0 points. A total score of >4 points indicates pain resulting from a neurological disorder, specifically neuropathic pain.	Pre-treatment