<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/NCT02219919</url>
  </required_header>
  <id_info>
    <org_study_id>HUFA-12/14</org_study_id>
    <nct_id>NCT02219919</nct_id>
  </id_info>
  <brief_title>Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome</brief_title>
  <official_title>Changes in Nociceptive Gain Processing After Physical Therapy and Surgery 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>
    <collaborator>
      <agency>Hospital San Carlos, Madrid</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 pain intensity and nociceptive&#xD;
      gain processing after the application of either physical therapy or surgery in women with&#xD;
      carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain&#xD;
      intensity, widespread pressure pain sensitivity and segmental thermal changes after the&#xD;
      application of a physical therapy program based on desensitization maneuvers of the central&#xD;
      nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up&#xD;
      periods. We hypothesize that the physical therapy intervention targeted to desensitization of&#xD;
      the central nervous system is more effective than surgical intervention for modulating&#xD;
      altered nociceptive gain processing in women with CTS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a&#xD;
      complex pain syndrome including both peripheral and central sensitization mechanisms. In&#xD;
      fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and&#xD;
      bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain&#xD;
      processing. In addition, these sensitization processes seem to be independent of&#xD;
      electro-diagnostic findings. Previous studies support the use of physical therapy and&#xD;
      surgical interventions for the management of pain and disability in these patients. However,&#xD;
      there is no evidence related to changes in nociceptive gain process after the application of&#xD;
      any therapeutic intervention. Preliminary evidence suggests that manual therapies can&#xD;
      modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized&#xD;
      clinical trial to determine if manual therapies including desensitization maneuvers of the&#xD;
      central nervous system are effective to decrease widespread pressure pain and thermal pain&#xD;
      hypersensitivity in women with CTS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in widespread pressure pain thresholds between baseline and follow-up periods</measure>
    <time_frame>Baseline and 3, 6, 9 and 12 months after the intervention.</time_frame>
    <description>Pressure pain thresholds over the median, ulnar and radial nerves, and over the cervical spine, the second metacarpal, and tibialis anterior muscles will be bilaterally assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in heat and cold pain thresholds between baseline and follow-up periods</measure>
    <time_frame>Baseline and 3, 6, 9 and 12 months after the intervention</time_frame>
    <description>Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain intensity between baseline and follow-ups periods</measure>
    <time_frame>Baseline and 3, 6, 9 and 12 months after the intervention</time_frame>
    <description>An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week. The mean value of the 3 scores will be used in the analysis at each follow-up period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Carpal Tunnel Syndrome</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 therapy including desensitization maneuvers of the central nervous system of 30 minutes 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>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>
  <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 therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.</description>
    <arm_group_label>Physical Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pain and paresthesia in the median nerve distribution&#xD;
&#xD;
          -  increasing symptoms during the night,&#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 or steroid injections;&#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 a systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);&#xD;
&#xD;
          -  history of other medical 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>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Rey Juan Carlos</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 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>Proffesor</investigator_title>
  </responsible_party>
  <keyword>Carpal Tunnel Syndrome</keyword>
  <keyword>Pain</keyword>
  <keyword>Sensitivity</keyword>
  <keyword>Pain Thresholds</keyword>
  <keyword>Sensitization</keyword>
  <keyword>Physical Therapy</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>
  <!-- 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/NCT02219919
org study id: HUFA-12/14
nct id: NCT02219919
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This randomized clinical trial will investigate changes in pain intensity and nociceptive
      gain processing after the application of either physical therapy or surgery in women with
      carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain
      intensity, widespread pressure pain sensitivity and segmental thermal changes after the
      application of a physical therapy program based on desensitization maneuvers of the central
      nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up
      periods. We hypothesize that the physical therapy intervention targeted to desensitization of
      the central nervous system is more effective than surgical intervention for modulating
      altered nociceptive gain processing in women with CTS.
There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a
      complex pain syndrome including both peripheral and central sensitization mechanisms. In
      fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and
      bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain
      processing. In addition, these sensitization processes seem to be independent of
      electro-diagnostic findings. Previous studies support the use of physical therapy and
      surgical interventions for the management of pain and disability in these patients. However,
      there is no evidence related to changes in nociceptive gain process after the application of
      any therapeutic intervention. Preliminary evidence suggests that manual therapies can
      modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized
      clinical trial to determine if manual therapies including desensitization maneuvers of the
      central nervous system are effective to decrease widespread pressure pain and thermal pain
      hypersensitivity in women with CTS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in widespread pressure pain thresholds between baseline and follow-up periods
time frame: Baseline and 3, 6, 9 and 12 months after the intervention.
description: Pressure pain thresholds over the median, ulnar and radial nerves, and over the cervical spine, the second metacarpal, and tibialis anterior muscles will be bilaterally assessed.
measure: Changes in heat and cold pain thresholds between baseline and follow-up periods
time frame: Baseline and 3, 6, 9 and 12 months after the intervention
description: Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.
measure: Changes in pain intensity between baseline and follow-ups periods
time frame: Baseline and 3, 6, 9 and 12 months after the intervention
description: An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week. The mean value of the 3 scores will be used in the analysis at each follow-up period.
arm group label: Physical Therapy Group
arm group type: Experimental
description: The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes 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: 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
intervention type: Other
intervention name: Physical Therapy Group
description: The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
arm group label: Physical Therapy 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: Proffesor
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome