<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/NCT04499014</url>
  </required_header>
  <id_info>
    <org_study_id>1234567</org_study_id>
    <nct_id>NCT04499014</nct_id>
  </id_info>
  <brief_title>Ultrasound and Phonophoresis in Carpal Tunnel Syndrome</brief_title>
  <official_title>Evaluation of the Effects of Steroid Phonophoresis and Therapeutic Ultrasound in Carpal Tunnel Syndrome: A Randomized Placebo - Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir City Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eskisehir City Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography&#xD;
      (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic&#xD;
      carpal tunnel syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided&#xD;
      three groups. The first group was ultrasound group, the second group was PH group and the&#xD;
      third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an&#xD;
      intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1%&#xD;
      dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm²&#xD;
      ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All&#xD;
      patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston&#xD;
      Symptom Severity Scale, Functional Capacity Scale, grip strength and&#xD;
      electroneurophysiological evaluations were compared before the treatment, after the treatment&#xD;
      and three months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2014</start_date>
  <completion_date type="Actual">January 15, 2016</completion_date>
  <primary_completion_date type="Actual">October 1, 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>three month</time_frame>
    <description>Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Boston Symptom Severity Scale</measure>
    <time_frame>three month</time_frame>
    <description>Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Boston Functional Capacity Scale</measure>
    <time_frame>three month</time_frame>
    <description>Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands</description>
  </primary_outcome>
  <primary_outcome>
    <measure>grip strength</measure>
    <time_frame>three month</time_frame>
    <description>Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>electroneurophysiological evaluations</measure>
    <time_frame>three month</time_frame>
    <description>Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>phonophoresis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo ultrasound</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>5 days a week, a total of 10 sessions</description>
    <arm_group_label>phonophoresis</arm_group_label>
    <arm_group_label>placebo ultrasound</arm_group_label>
    <arm_group_label>ultrasound</arm_group_label>
    <other_name>phonophoresis</other_name>
    <other_name>placebo ultrasound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or&#xD;
             spontaneous activity on electrophysiological examination of the abductor pollicis&#xD;
             brevis (APB) muscle)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic&#xD;
             diseases, acute trauma, pregnancy etc.)&#xD;
&#xD;
          -  cervical radiculopathy&#xD;
&#xD;
          -  etiologic factors which predispose to or polyneuropathy&#xD;
&#xD;
          -  reinnervation or fibrillation potentials in their abductor pollicis brevis muscles&#xD;
&#xD;
          -  physical or medical therapy within 3 months for CTS and steroid injection applied&#xD;
&#xD;
          -  experience CTS median nerve trauma and CTS surgery&#xD;
&#xD;
          -  serious thenar atrophy and anesthesia&#xD;
&#xD;
          -  contraindication in steroid treatment (steroid allergies, hypertension etc.)&#xD;
&#xD;
          -  contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the&#xD;
             joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory&#xD;
             disorders etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Burcu Ortanca</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eskişehir City Hospital</affiliation>
  </overall_official>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir City Hospital</investigator_affiliation>
    <investigator_full_name>Fulya Bakılan</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>carpal tunnel syndrome</keyword>
  <keyword>steroid phonophoresis</keyword>
  <keyword>ultrasound</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/NCT04499014
org study id: 1234567
nct id: NCT04499014
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography
      (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic
      carpal tunnel syndrome.
Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided
      three groups. The first group was ultrasound group, the second group was PH group and the
      third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an
      intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1%
      dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm²
      ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All
      patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston
      Symptom Severity Scale, Functional Capacity Scale, grip strength and
      electroneurophysiological evaluations were compared before the treatment, after the treatment
      and three months later.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Visual Analogue Scale
time frame: three month
description: Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.
measure: Boston Symptom Severity Scale
time frame: three month
description: Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity
measure: Boston Functional Capacity Scale
time frame: three month
description: Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands
measure: grip strength
time frame: three month
description: Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated
measure: electroneurophysiological evaluations
time frame: three month
description: Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)
arm group label: ultrasound
arm group type: Experimental
description: ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions
arm group label: phonophoresis
arm group type: Experimental
description: an intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions
arm group label: placebo ultrasound
arm group type: Placebo Comparator
description: same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions
intervention type: Device
intervention name: ultrasound
description: 5 days a week, a total of 10 sessions
arm group label: phonophoresis
arm group label: placebo ultrasound
arm group label: ultrasound
other name: phonophoresis
other name: placebo ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Burcu Ortanca
role: Principal Investigator
affiliation: Eskişehir City Hospital
responsible party type: Principal Investigator
investigator affiliation: Eskisehir City Hospital
investigator full name: Fulya Bakılan
investigator title: Medical Doctor
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome