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RecruitingNCT06239259Updated May 20, 2026

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

An observational study in Carpal Tunnel Syndrome, sponsored by Siriraj Hospital. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Siriraj Hospital · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carpal Tunnel Syndrome

Keywords

  • Carpal Tunnel Syndrome
  • Diagnosis
  • Content validity
03

In context

Carpal Tunnel Syndrome

587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's planned enrollment of 80 is below the median of 94 across 130 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Carpal tunnel syndrome patients who recieved conservative treatment at Single-center, Siriraj hospital, Thailand

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Carpal tunnel syndrome patients

    Carpal tunnel syndrome patients

    Other: Questionare As described in Secondary Outcomes

Interventions

  • OtherQuestionare 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

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What researchers measure

Primary outcomes

  1. Validity of Thai version of Kamath and Stothard Questionnaire in carpal tunnel syndrome patients

    The questionnaire composes of 9 clinical questions asking whether the patient has any symptom of carpal tunnel syndrome. The total score is the sum of the score from each question. Total score ranges from -2 to 11. Higher scores indicate a greater probability of the condition, prompting further investigation and potential referral to a specialist. Concurrent validity is evaluated by comparing this questionnaire with the Boston carpal tunnel questionnaire.

    Time frame: Pre-treatment

  2. Reliability of Thai version of Kamath and Stothard Questionnaire in carpal tunnel syndrome patients

    The questionnaire composes of 9 clinical questions asking whether the patient has any symptom of carpal tunnel syndrome. The total score is the sum of the score from each question. Total score ranges from -2 to 11. Higher scores indicate a greater probability of the condition, prompting further investigation and potential referral to a specialist. Intra-observer reliability is measured using Kappa statistics for each answered question between two different periods.

    Time frame: Pre-treatment and 2 weeks later

Secondary outcomes

  1. Thai version of Boston carpal tunnel questionnaire (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). Symptom Severity Scale (SSS): The scores for each item are averaged to provide a mean score, ranging from 1-5. Higher scores indicate more severe symptoms. Functional Status Scale (FSS): The scores for each item are averaged to provide a mean score, ranging from 1-5. Higher scores indicate greater difficulty in performing daily activities.

    Time frame: Pre-treatment

  2. Thai version of EQ-5D-5L questionaire

    This questionnaire comprises of two parts: 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. Part 2, directly assessing health conditions on a visual analog scale from 0 to 100. Here, 0 represents the most adverse change in health, and 100 represents the most positive change in health.

    Time frame: Pre-treatment

  3. 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: Pain subscale 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: Function subscale 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. The pain subscale has a maximum total score of 50 and the function subscale has a maximum total score of 100. A higher score reflects more pain or greater difficulty in performing the activities. The total score for the PRWE is obtained from a summation of the total pain subscale and half of the total function subscale.

    Time frame: Pre-treatment

  4. Thai version of Quick Disabilities of Arm, Shoulder and Hand questionaire (QuickDASH)

    The QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the original DASH questionnaire, designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. It consists of 11 items. Patients rate their difficulty or severity of symptoms over the past week on a scale from 1 (no difficulty) to 5 (unable to perform). The average score is the sum of responded items divided by number of completed items. Then, the average score is transform to a 0-100 scale by subtracting the average score with 1 and divided by 4 and then multiply with 25.

    Time frame: Pre-treatment

  5. 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: Part 1 is a section with patient interview questions comprising 7 yes or no questions. Each 'yes' answer is scored as 1 point and 'no' answer is scored as 0 point. Part 2 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.

    Time frame: Pre-treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 9667616 ↗
  • von Schroeder HP, Botte MJ. Carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):643-55. PubMed 8953285 ↗
  • 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. PubMed 26612240 ↗
  • 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: 10.2106/00004623-199311000-00002. PubMed 8245050 ↗
  • Upatham S, Kumnerddee W. Reliability of Thai version Boston questionnaire. J Med Assoc Thai. 2008 Aug;91(8):1250-6. PubMed 18788699 ↗
  • 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. PubMed 12954256 ↗
  • Bonett DG. Sample size requirements for estimating intraclass correlations with desired precision. Stat Med. 2002 May 15;21(9):1331-5. doi: 10.1002/sim.1108. PubMed 12111881 ↗
  • 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 2012 Aug 25. PubMed 22926727 ↗
  • 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(4):275-81.
  • Bonett, DG, Wright, TA. Cronbach's alpha reliability: Interval estimation, hypothesis testing, and sample size planning. J Organiz Behav 2015; 36: 3-15.
  • 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. PubMed 24100056 ↗
  • 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. PubMed 17957931 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2024
First posted
Feb 2, 2024
StartActual
Jul 6, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06239259
Lead sponsor
Siriraj Hospital
Responsible party
Panai Laohaprasitiporn, MD (Principle investigator, Siriraj Hospital) — Principal investigator
First posted
Feb 2, 2024
Start date
Jul 6, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 20, 2026

Study contacts

Panai Laohaprasitiporn, M.D.
Contact
panai.lao@mahidol.ac.th
+6624197958
Pongsathorn Samphaotong
Contact
pongsathorn.sap@gmail.com
+66916099570

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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