<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03782558</url>
  </required_header>
  <id_info>
    <org_study_id>JagiellonianU60</org_study_id>
    <nct_id>NCT03782558</nct_id>
  </id_info>
  <brief_title>Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire</brief_title>
  <official_title>Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jakub Antczak</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centrum Neurologii Klinicznej Krakowska Akademia Neurologii</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jagiellonian University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carpal tunnel syndrome is the most common compression neuropathy. The compression of the&#xD;
      median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations&#xD;
      in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other&#xD;
      muscles innervated by median nerve occurs, which may lead to permanent impairment of manual&#xD;
      performance. The Boston carpal tunnel questionnaire (BCTQ) is one of the most commonly used&#xD;
      tools for monitoring of the disease progression and of the effect of therapy. Originally&#xD;
      created in English, it has been translated into many languages and subsequently validated.&#xD;
      Recently the Polish version has been created and the purpose of this study is to validate it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The compression of&#xD;
      the median nerve occurs in the carpal tunnel and results in pain and other unpleasant&#xD;
      sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and&#xD;
      other muscles innervated by median nerve occurs, which may lead to permanent impairment of&#xD;
      manual performance. The Boston carpal tunnel questionnaire (BCTQ) (Levine et al. 1993) is one&#xD;
      of the most commonly used tools for monitoring of the disease progression and of the effect&#xD;
      of therapy. It is a self administered questionnaire, which consists of two subscales, the&#xD;
      Symptom severity scale and the Functional status scale. In the first one, the severity of&#xD;
      particular symptoms is rated between none or never to very severe or continuous where&#xD;
      appropriate. In the second one, the difficulties in performing several typical daily tasks,&#xD;
      requiring manual activity is rated between &quot;no difficulty&quot; to &quot;cannot perform activity at all&#xD;
      due to hands and wrists symptoms&quot;. Originally created in English, it has been translated into&#xD;
      many languages and subsequently validated. Recently the Polish version has been created&#xD;
      (Polish version of the Boston Carpal Tunnel Questionnaire - pBCTQ) and the purpose of this&#xD;
      study is to validate it. The translation from English to Polish has been independently made&#xD;
      by two health professionals, native Polish speakers with good acquired knowledge of English.&#xD;
      Next, both Polish versions were independently backward-translated to English, by two native&#xD;
      English speakers with good acquired knowledge of Polish. Finally, all translators met&#xD;
      together and all translations were presented to everyone of them. Possible mistakes in&#xD;
      translations from original version into Polish, which might led to discrepancies between&#xD;
      backwardly translated versions (from Polish to English) and the original version were&#xD;
      discussed and the final version was created. The first step of the study on validation of the&#xD;
      Polish version will be the pre-testing. In this step, pBCTQ will be administered to small&#xD;
      sample of patients (ten in this study) and the investigators will interview in detail how&#xD;
      these participants understand each question of the questionnaire. If pre-testing reveals that&#xD;
      patients may understand any question differently from its meaning in the original version,&#xD;
      final adjustments will be discussed among the translators and possibly introduced.&#xD;
&#xD;
      The final pBCTQ will be administered before and after surgical treatment to the convenience&#xD;
      group of 120 patients with electrodiagnostically confirmed CTS. Moreover, 30 randomly&#xD;
      selected patients will be asked to fill out pBCTQ additionally, two weeks after first&#xD;
      administration but before surgical treatment. Data from this subgroup will serve to assess&#xD;
      the test-retest reliability. pBCTQ will be tested also regarding its consistency, validity&#xD;
      and reactivity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">September 9, 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Internal Consistency</measure>
    <time_frame>Through study completion, an average of six months.</time_frame>
    <description>Consistency between two subscales of pBCTQ (Symptom severity scale and Functional status scale) will be evaluated using Cronbach alfa test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validity</measure>
    <time_frame>Through study completion, an average of six months.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reactivity: Correlation between changes in pBCTQ and electrophysiologic severity of CTS</measure>
    <time_frame>Before treatment and then three months after surgical treatment of CTS</time_frame>
    <description>The reactivity will be evaluated as correlation between change in electrophysiologic severity level of CTS and changes in both pBCTQ subscales after treatment.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients with CTS</arm_group_label>
    <description>Surgical transection of transverse ligament</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical transection of transverse ligament</intervention_name>
    <description>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.</description>
    <arm_group_label>Patients with CTS</arm_group_label>
    <other_name>Surgical transection of flexor retinaculum</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from the patients referred to Krakowska Akademia Neurologii&#xD;
        Centrum Neurologii Klinicznej for electrohysiologic verification of their initial, clinical&#xD;
        diagnosis of CTS. After the electrophysiology confirms the CTS, the patient will be asked&#xD;
        if she/he would like to take part in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of at least one symptom within hand and / or wrist, from the following:&#xD;
             paresthesias, sensory loss, tingling, burning sensation, impression of swelling.&#xD;
&#xD;
          -  Electrophysiologic confirmation of CTS, which will base on the abnormal latency&#xD;
             difference in sensory or motor conduction between median and ulnar nerve or on sensory&#xD;
             conduction slowing in median nerve, or on the prolongation of distal motor latency of&#xD;
             the median nerve.&#xD;
&#xD;
        (bilateral CTS will be included. pBCTQ will be filled out separately for each hand and the&#xD;
        outcomes wil be measured separately for each hand).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical signs or symptoms and /or electrophysiologic results indicative of more&#xD;
             generalized peripheral neuropathy.&#xD;
&#xD;
          -  Presence of conditions, which may lead to the development of peripheral neuropathy&#xD;
             such as diabetes, renal insufficiency, hypothyroidism or amyloidosis.&#xD;
&#xD;
          -  Presence of conditions, which may clinically resemble CTS, such as cervical&#xD;
             radiculopathy or myelopathy or thoracic outlet syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jakub Antczak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jagiellonian University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Krakowska Akademia Neurologii Centrum Neurologii Klinicznej</name>
      <address>
        <city>Cracovia</city>
        <zip>31505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jagiellonian University Medical College</name>
      <address>
        <city>Cracovia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.</citation>
    <PMID>9325471</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8245050</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>September 9, 2023</last_update_submitted>
  <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jagiellonian University</investigator_affiliation>
    <investigator_full_name>Jakub Antczak</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>carpal tunnel syndrome</keyword>
  <keyword>pBCTQ</keyword>
  <keyword>validation</keyword>
  <keyword>nerve conduction study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03782558
org study id: JagiellonianU60
nct id: NCT03782558
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Internal Consistency
time frame: Through study completion, an average of six months.
description: Consistency between two subscales of pBCTQ (Symptom severity scale and Functional status scale) will be evaluated using Cronbach alfa test.
measure: Validity
time frame: Through study completion, an average of six months.
description: 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).
measure: Reactivity: Correlation between changes in pBCTQ and electrophysiologic severity of CTS
time frame: Before treatment and then three months after surgical treatment of CTS
description: The reactivity will be evaluated as correlation between change in electrophysiologic severity level of CTS and changes in both pBCTQ subscales after treatment.
arm group label: Patients with CTS
description: Surgical transection of transverse ligament
intervention type: Procedure
intervention name: Surgical transection of transverse ligament
description: 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.
arm group label: Patients with CTS
other name: Surgical transection of flexor retinaculum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jakub Antczak, MD
role: Principal Investigator
affiliation: Jagiellonian University
facility: 
facility: 
country: Poland
citation: Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
PMID: 9325471
citation: 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.
PMID: 8245050
responsible party type: Sponsor-Investigator
investigator affiliation: Jagiellonian University
investigator full name: Jakub Antczak
investigator title: Principal Investigator
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
sharing ipd: Undecided