<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/NCT02198521</url>
  </required_header>
  <id_info>
    <org_study_id>2009P001019 AME 339</org_study_id>
    <nct_id>NCT02198521</nct_id>
  </id_info>
  <brief_title>Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?</brief_title>
  <official_title>Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Title Staged Bilateral Carpal Tunnel Release: Which Side Hurts More? Primary null hypothesis&#xD;
      Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in&#xD;
      overall pain intensity of pain between sides.&#xD;
&#xD;
      Secondary null hypotheses&#xD;
&#xD;
        -  There is no correlation in overall pain intensity after open CTR surgery and distal&#xD;
           sensory latency, distal motor latency, electromyography (EMG), demographics, occupation,&#xD;
           avocation, relevant comorbidities, dominance, left vs. right, Pain Self-Efficacy,&#xD;
           Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity or&#xD;
           PROMIS depression when both surgeries are performed within 6 months.&#xD;
&#xD;
        -  There is no difference in satisfaction with treatment at the time of suture removal&#xD;
           after the first and second open CTR surgery when both are performed within 6 months..&#xD;
&#xD;
      IRB: 2009-p-001-019 ClinicalTrials.gov: Not mandatory, (b/o observational) Authors:&#xD;
      Drijkoningen, Braun, Ring Journal: To be discussed Design: Prospective cohort study&#xD;
      Background Many hand surgeons note that patients undergoing staged bilateral open carpal&#xD;
      tunnel release often experience more pain with the second side. The investigator felt this&#xD;
      was an easily testable hypothesis worthy of study.&#xD;
&#xD;
      Subjects&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Inclusion:&#xD;
&#xD;
        -  Age 18 or older&#xD;
&#xD;
        -  Idiopathic carpal tunnel syndrome&#xD;
&#xD;
        -  No prior surgery for carpal tunnel syndrome&#xD;
&#xD;
      Exclude:&#xD;
&#xD;
        -  Pregnant women&#xD;
&#xD;
        -  Not fluent in English&#xD;
&#xD;
      Response Variables:&#xD;
&#xD;
        -  11-point ordinal measure of overall pain intensity during and after surgery measured at&#xD;
           the time of suture removal.&#xD;
&#xD;
        -  11-point ordinal measure of satisfaction with treatment&#xD;
&#xD;
        -  PROMIS upper extremity&#xD;
&#xD;
      Explanatory Variables:&#xD;
&#xD;
        -  Distal Sensory Latency (DSL)&#xD;
&#xD;
        -  Distal Motor Latency (DML)&#xD;
&#xD;
        -  EMG changes&#xD;
&#xD;
        -  Demographics: age, sex, race, occupation, avocation&#xD;
&#xD;
        -  Time limit between two surgeries &lt; 6 months&#xD;
&#xD;
        -  Relevant comorbidities: Trapeziometacarpal (TMC) arthrosis, ulnar neuropathy, trigger&#xD;
           finger&#xD;
&#xD;
        -  Involved hand (Dominance, Side)&#xD;
&#xD;
        -  First side vs. second side surgery&#xD;
&#xD;
        -  PROMIS Pain Interference Computer Adaptive Testing (CAT)&#xD;
&#xD;
        -  Pain Self Efficacy Questionnaire (PSEQ-2)&#xD;
&#xD;
        -  PROMIS Depression&#xD;
&#xD;
      Methods The investigator and study staff will invite all adult patients (age 18 and older)&#xD;
      presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts&#xD;
      General Hospital (MGH) with bilateral carpal tunnel syndrome planning staged bilateral carpal&#xD;
      tunnel release.&#xD;
&#xD;
      Analysis Power analysis An a priori power analysis for matched pairs was performed. To detect&#xD;
      the difference between two dependent means an effect size of 0.5 at alpha of 0.05 and 80%&#xD;
      power, a total sample size of 34 patients is needed.As the investigator expects to have&#xD;
      patients who will be lost to follow-up the investigators will count 10% extra, a total of 38&#xD;
      patients will be needed.&#xD;
&#xD;
      Univariate analysis: Variables will be presented with frequencies and percentages for&#xD;
      categorical variables and as mean with standard deviation or median with interquartile range&#xD;
      for respectively normal or non-normal distributed continuous variables. Normality of&#xD;
      continuous distributed variables will be tested a paired T-Test.&#xD;
&#xD;
      Bivariate and multivariable analysis will be performed and subsequently all variables with a&#xD;
      probability &lt; 0.10 in bivariate analysis will be inserted in a backward, stepwise,&#xD;
      multivariable linear regression analysis to assess their ability to explain variation in&#xD;
      outcome. The 11 point Likert Pain scale score is considered significant when there is a&#xD;
      difference of more than 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The researcher and principal investigator working on this study left the institution.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date>September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Overall Pain Intensity</measure>
    <time_frame>2 weeks after surgery within 6 month timeframe</time_frame>
    <description>The overall pain intensity is measured on an 11-point ordinal measure of overall pain intensity after surgery measured at the time of suture removal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Satisfaction</measure>
    <time_frame>2 weeks after surgery within a 6 month timeframe</time_frame>
    <description>11-point ordinal measure of satisfaction with treatment measured 2 weeks after surgery during suture removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome for Upper Extremity Function</measure>
    <time_frame>2 weeks after surgery within 6 month timeframe</time_frame>
    <description>PROMIS upper extremity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electromyogram Results</measure>
    <time_frame>Before Surgery</time_frame>
    <description>EMG DSL and DML</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics</measure>
    <time_frame>2 weeks after first surgery</time_frame>
    <description>Age, sex, race, occupation, avocation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidities</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Relevant comorbidities: TMC Arthrosis, ulnar neuropathy, trigger finger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Dominance and Side of Surgery</measure>
    <time_frame>2 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Pain Interference</measure>
    <time_frame>2 weeks after surgery within 6 month timeframe</time_frame>
    <description>PROMIS Pain Interference (CAT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Self Efficacy Questionnaire</measure>
    <time_frame>2 weeks after surgery within 6 month timeframe</time_frame>
    <description>PSEQ-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Depression</measure>
    <time_frame>2 weeks after surgery within 6 month timeframe</time_frame>
    <description>PROMIS Depression</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Bilateral Carpal Tunnel Syndrome (CTS)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Bilateral CTS patients undergoing bilateral carpal tunnel release&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Idiopathic carpal tunnel syndrome&#xD;
&#xD;
          -  No prior surgery for carpal tunnel syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Not fluent in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>June 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David C. Ring, MD</investigator_full_name>
    <investigator_title>MD/PhD</investigator_title>
  </responsible_party>
  <keyword>Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in overall pain intensity of pain between sides.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel 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/NCT02198521
org study id: 2009P001019 AME 339
nct id: NCT02198521
lead sponsor: 
has dmc: No
Title Staged Bilateral Carpal Tunnel Release: Which Side Hurts More? Primary null hypothesis
      Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in
      overall pain intensity of pain between sides.

      Secondary null hypotheses

        -  There is no correlation in overall pain intensity after open CTR surgery and distal
           sensory latency, distal motor latency, electromyography (EMG), demographics, occupation,
           avocation, relevant comorbidities, dominance, left vs. right, Pain Self-Efficacy,
           Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity or
           PROMIS depression when both surgeries are performed within 6 months.

        -  There is no difference in satisfaction with treatment at the time of suture removal
           after the first and second open CTR surgery when both are performed within 6 months..

      IRB: 2009-p-001-019 ClinicalTrials.gov: Not mandatory, (b/o observational) Authors:
      Drijkoningen, Braun, Ring Journal: To be discussed Design: Prospective cohort study
      Background Many hand surgeons note that patients undergoing staged bilateral open carpal
      tunnel release often experience more pain with the second side. The investigator felt this
      was an easily testable hypothesis worthy of study.

      Subjects

      Eligibility:

      Inclusion:

        -  Age 18 or older

        -  Idiopathic carpal tunnel syndrome

        -  No prior surgery for carpal tunnel syndrome

      Exclude:

        -  Pregnant women

        -  Not fluent in English

      Response Variables:

        -  11-point ordinal measure of overall pain intensity during and after surgery measured at
           the time of suture removal.

        -  11-point ordinal measure of satisfaction with treatment

        -  PROMIS upper extremity

      Explanatory Variables:

        -  Distal Sensory Latency (DSL)

        -  Distal Motor Latency (DML)

        -  EMG changes

        -  Demographics: age, sex, race, occupation, avocation

        -  Time limit between two surgeries < 6 months

        -  Relevant comorbidities: Trapeziometacarpal (TMC) arthrosis, ulnar neuropathy, trigger
           finger

        -  Involved hand (Dominance, Side)

        -  First side vs. second side surgery

        -  PROMIS Pain Interference Computer Adaptive Testing (CAT)

        -  Pain Self Efficacy Questionnaire (PSEQ-2)

        -  PROMIS Depression

      Methods The investigator and study staff will invite all adult patients (age 18 and older)
      presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts
      General Hospital (MGH) with bilateral carpal tunnel syndrome planning staged bilateral carpal
      tunnel release.

      Analysis Power analysis An a priori power analysis for matched pairs was performed. To detect
      the difference between two dependent means an effect size of 0.5 at alpha of 0.05 and 80%
      power, a total sample size of 34 patients is needed.As the investigator expects to have
      patients who will be lost to follow-up the investigators will count 10% extra, a total of 38
      patients will be needed.

      Univariate analysis: Variables will be presented with frequencies and percentages for
      categorical variables and as mean with standard deviation or median with interquartile range
      for respectively normal or non-normal distributed continuous variables. Normality of
      continuous distributed variables will be tested a paired T-Test.

      Bivariate and multivariable analysis will be performed and subsequently all variables with a
      probability < 0.10 in bivariate analysis will be inserted in a backward, stepwise,
      multivariable linear regression analysis to assess their ability to explain variation in
      outcome. The 11 point Likert Pain scale score is considered significant when there is a
      difference of more than 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]
observational model: Cohort
time perspective: Prospective
measure: Overall Pain Intensity
time frame: 2 weeks after surgery within 6 month timeframe
description: The overall pain intensity is measured on an 11-point ordinal measure of overall pain intensity after surgery measured at the time of suture removal.
measure: Overall Satisfaction
time frame: 2 weeks after surgery within a 6 month timeframe
description: 11-point ordinal measure of satisfaction with treatment measured 2 weeks after surgery during suture removal
measure: Patient Reported Outcome for Upper Extremity Function
time frame: 2 weeks after surgery within 6 month timeframe
description: PROMIS upper extremity
measure: Electromyogram Results
time frame: Before Surgery
description: EMG DSL and DML
measure: Demographics
time frame: 2 weeks after first surgery
description: Age, sex, race, occupation, avocation
measure: Comorbidities
time frame: 2 weeks after surgery
description: Relevant comorbidities: TMC Arthrosis, ulnar neuropathy, trigger finger
measure: Hand Dominance and Side of Surgery
time frame: 2 weeks after surgery
measure: Patient Reported Pain Interference
time frame: 2 weeks after surgery within 6 month timeframe
description: PROMIS Pain Interference (CAT)
measure: Patient Self Efficacy Questionnaire
time frame: 2 weeks after surgery within 6 month timeframe
description: PSEQ-2
measure: Patient Reported Depression
time frame: 2 weeks after surgery within 6 month timeframe
description: PROMIS Depression
arm group label: Bilateral Carpal Tunnel Syndrome (CTS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David C. Ring, MD
investigator title: MD/PhD
mesh term: Carpal Tunnel Syndrome