Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      Carpal tunnel syndrome 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) is one of the most commonly used
      tools for monitoring of the disease progression and of the effect of therapy. Originally
      created in English, it has been translated into many languages and subsequently validated.
      Recently the Polish version has been created and the purpose of this study is to validate it.
    

Detailed description: 
      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.
    

Intervention name(s): Surgical transection of transverse ligament
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Surgical transection of flexor retinaculum
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the patients referred to Krakowska Akademia Neurologii
        Centrum Neurologii Klinicznej for electrohysiologic verification of their initial, clinical
        diagnosis of CTS. After the electrophysiology confirms the CTS, the patient will be asked
        if she/he would like to take part in the study.
      
Keywords: carpal tunnel syndrome; pBCTQ; validation; nerve conduction study