Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire
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|ClinicalTrials.gov Identifier: NCT03782558|
Recruitment Status : Enrolling by invitation
First Posted : December 20, 2018
Last Update Posted : January 24, 2019
|Condition or disease||Intervention/treatment|
|Carpal Tunnel Syndrome||Procedure: Surgical transection of transverse ligament|
Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. The Boston carpal tunnel questionnaire (BCTQ) (Levine et al. 1993) is one of the most commonly used tools for monitoring of the disease progression and of the effect of therapy. It is a self administered questionnaire, which consists of two subscales, the Symptom severity scale and the Functional status scale. In the first one, the severity of particular symptoms is rated between none or never to very severe or continuous where appropriate. In the second one, the difficulties in performing several typical daily tasks, requiring manual activity is rated between "no difficulty" to "cannot perform activity at all due to hands and wrists symptoms". Originally created in English, it has been translated into many languages and subsequently validated. Recently the Polish version has been created (Polish version of the Boston Carpal Tunnel Questionnaire - pBCTQ) and the purpose of this study is to validate it. The translation from English to Polish has been independently made by two health professionals, native Polish speakers with good acquired knowledge of English. Next, both Polish versions were independently backward-translated to English, by two native English speakers with good acquired knowledge of Polish. Finally, all translators met together and all translations were presented to everyone of them. Possible mistakes in translations from original version into Polish, which might led to discrepancies between backwardly translated versions (from Polish to English) and the original version were discussed and the final version was created. The first step of the study on validation of the Polish version will be the pre-testing. In this step, pBCTQ will be administered to small sample of patients (ten in this study) and the investigators will interview in detail how these participants understand each question of the questionnaire. If pre-testing reveals that patients may understand any question differently from its meaning in the original version, final adjustments will be discussed among the translators and possibly introduced.
The final pBCTQ will be administered before and after surgical treatment to the convenience group of 120 patients with electrodiagnostically confirmed CTS. Moreover, 30 randomly selected patients will be asked to fill out pBCTQ additionally, two weeks after first administration but before surgical treatment. Data from this subgroup will serve to assess the test-retest reliability. pBCTQ will be tested also regarding its consistency, validity and reactivity.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||November 15, 2020|
Patients with CTS
Surgical transection of transverse ligament
Procedure: Surgical transection of transverse ligament
Standard therapy for CTS. An incision is made at the base of the palm of the hand. Then the transverse ligament is cut, which releases the compression of the median nerve and improves the symptoms.
Other Name: Surgical transection of flexor retinaculum
- Internal Consistency [ Time Frame: Through study completion, an average of six months. ]Consistency between two subscales of pBCTQ (Symptom severity scale and Functional status scale) will be evaluated using Cronbach alfa test.
- Validity [ Time Frame: Through study completion, an average of six months. ]Validity will be tested by calculating the correlation of the subscore of each of two parts of the questionnaire with the electrophysiologic, six-grade severity level according to Padua et al. (1997).
- Reactivity: Correlation between changes in pBCTQ and electrophysiologic severity of CTS [ Time Frame: Before treatment and then three months after surgical treatment of CTS ]The reactivity will be evaluated as correlation between change in electrophysiologic severity level of CTS and changes in both pBCTQ subscales after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782558
|Krakowska Akademia Neurologii Centrum Neurologii Klinicznej|
|Cracovia, Poland, 31505|
|Principal Investigator:||Jakub M Antczak, MD||Jagiellonian University Medical College, Department of Neurology|