<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/NCT02233660</url>
  </required_header>
  <id_info>
    <org_study_id>HUFA PI -12/0023</org_study_id>
    <nct_id>NCT02233660</nct_id>
  </id_info>
  <brief_title>The Role of the Cervical Spine in Carpal Tunnel Syndrome</brief_title>
  <official_title>Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario Fundación Alcorcón</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial will investigate changes in hand function, active cervical&#xD;
      range of motion and pinch grip force after the application of physical therapy in women with&#xD;
      carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function,&#xD;
      cervical range of motion and pinch grip force induced after the application of a physical&#xD;
      therapy program including manual therapies targeted to those areas related to the median&#xD;
      nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The&#xD;
      hypothesis is that manual therapy is more effective for increasing cervical range of motion&#xD;
      and pinch grip force, but similarly effective for improving function, than surgical treatment&#xD;
      in women with CTS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is some evidence suggesting that CTS is associated with restricted cervical range of&#xD;
      motion and deficits in pinch grip force. In fact, restricted cervical range of motion and&#xD;
      deficits in pinch grip force seems to be independent of electro-diagnostic findings. These&#xD;
      findings would be associated with the proposed &quot;double crush syndrome&quot; theory. However no&#xD;
      longitudinal studies have been conducted. Further it has been demonstrated that hand function&#xD;
      is associated to deficits in these outcomes. Since previous studies support the use of&#xD;
      physical therapy and surgical interventions for the management of function in these patients,&#xD;
      the aim of this study is to conduct a randomized clinical trial to determine if changes in&#xD;
      hand function are related to changes in active cervical range of motion and pinch grip force&#xD;
      after the application of a physical therapy program including manual therapies targeted to&#xD;
      those areas related to the median nerve or endoscopic surgery in women with CTS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in hand function between baseline and follow-up periods</measure>
    <time_frame>Baseline and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in active cervical range of motion between baseline and follow-up periods</measure>
    <time_frame>Baseline and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>A cervical range of motion (CROM) device will be used to assess cervical range of motion in a single direction: flexion, extension, lateral flexion toward or away from the side of the CTS, and rotation toward or away from the side of the CTS. For patients with unilateral symptoms, sides are classified as affected or unaffected whereas in those with bilateral symptoms, the most painful side will be considered as the affected side and the less painful side as the unaffected side.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pinch grip force between baseline and follow-up periods</measure>
    <time_frame>Baseline and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Pinch grip force between the tip of the thumb with the tip of the index or the little finger will be measured with a pinch grip dynamometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Carpal Tunnel Syndromes</condition>
  <arm_group>
    <arm_group_label>Physical Therapy Group.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy Group</intervention_name>
    <description>The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.</description>
    <arm_group_label>Physical Therapy Group.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Group</intervention_name>
    <description>The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.</description>
    <arm_group_label>Surgical Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pain and paresthesia in the median nerve distribution&#xD;
&#xD;
          -  Positive Tinel sign,&#xD;
&#xD;
          -  Positive Phalen sign,&#xD;
&#xD;
          -  Symptoms had to have persisted for at least 6 months&#xD;
&#xD;
          -  Deficits of sensory and motor median nerve conduction according to guidelines of the&#xD;
             American Association of Electrodiagnosis, American Academy of Neurology, and the&#xD;
             American Physical Medicine and Rehabilitation Academy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any sensory/motor deficit related to the ulnar or radial nerve;&#xD;
&#xD;
          -  Older than 65 years of age;&#xD;
&#xD;
          -  Previous surgical intervention, steroid injections or physical therapy intervention&#xD;
&#xD;
          -  Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);&#xD;
&#xD;
          -  History of neck, shoulder, or upper limb trauma (whiplash);&#xD;
&#xD;
          -  History of any systemic disease causing CTS (eg, diabetes mellitus or thyroid&#xD;
             disease);&#xD;
&#xD;
          -  History of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Alcorcon</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Rey Juan Carlos</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>March 14, 2016</last_update_submitted>
  <last_update_submitted_qc>March 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>César Fernández-de-las-Peñas</investigator_full_name>
    <investigator_title>Head Division</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT02233660
org study id: HUFA PI -12/0023
nct id: NCT02233660
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized clinical trial will investigate changes in hand function, active cervical
      range of motion and pinch grip force after the application of physical therapy in women with
      carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function,
      cervical range of motion and pinch grip force induced after the application of a physical
      therapy program including manual therapies targeted to those areas related to the median
      nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The
      hypothesis is that manual therapy is more effective for increasing cervical range of motion
      and pinch grip force, but similarly effective for improving function, than surgical treatment
      in women with CTS.
There is some evidence suggesting that CTS is associated with restricted cervical range of
      motion and deficits in pinch grip force. In fact, restricted cervical range of motion and
      deficits in pinch grip force seems to be independent of electro-diagnostic findings. These
      findings would be associated with the proposed "double crush syndrome" theory. However no
      longitudinal studies have been conducted. Further it has been demonstrated that hand function
      is associated to deficits in these outcomes. Since previous studies support the use of
      physical therapy and surgical interventions for the management of function in these patients,
      the aim of this study is to conduct a randomized clinical trial to determine if changes in
      hand function are related to changes in active cervical range of motion and pinch grip force
      after the application of a physical therapy program including manual therapies targeted to
      those areas related to the median nerve or endoscopic surgery in women with CTS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in hand function between baseline and follow-up periods
time frame: Baseline and 1, 3, 6 and 12 months after the intervention
description: The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.
measure: Changes in active cervical range of motion between baseline and follow-up periods
time frame: Baseline and 1, 3, 6 and 12 months after the intervention
description: A cervical range of motion (CROM) device will be used to assess cervical range of motion in a single direction: flexion, extension, lateral flexion toward or away from the side of the CTS, and rotation toward or away from the side of the CTS. For patients with unilateral symptoms, sides are classified as affected or unaffected whereas in those with bilateral symptoms, the most painful side will be considered as the affected side and the less painful side as the unaffected side.
measure: Changes in pinch grip force between baseline and follow-up periods
time frame: Baseline and 1, 3, 6 and 12 months after the intervention
description: Pinch grip force between the tip of the thumb with the tip of the index or the little finger will be measured with a pinch grip dynamometer
arm group label: Physical Therapy Group.
arm group type: Experimental
description: The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
arm group label: Surgical Group
arm group type: Active Comparator
description: The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
intervention type: Other
intervention name: Physical Therapy Group
description: The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
arm group label: Physical Therapy Group.
intervention type: Procedure
intervention name: Surgical Group
description: The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
arm group label: Surgical Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Head Division
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome