<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/NCT03792945</url>
  </required_header>
  <id_info>
    <org_study_id>AhiEvranUERH</org_study_id>
    <nct_id>NCT03792945</nct_id>
  </id_info>
  <brief_title>Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS</brief_title>
  <official_title>Comparison of the Efficacy of Corticosteroid Injection and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Carpal Tunnel Syndrome; A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahi Evran University Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ahi Evran University Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal&#xD;
      shock wave therapy) and local corticosteroid injection in patients with carpal tunnel&#xD;
      syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the&#xD;
      investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and&#xD;
      reliable as local corticosteroid injection, which is the least invasive treatment. Mild and&#xD;
      moderate CTS patients will be determined according to American Association of&#xD;
      Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will&#xD;
      be included in the study. The participants will be informed about their participation in a&#xD;
      study and written informed consent will be obtained.The demographic characteristics and&#xD;
      disease duration of the participants will be recorded.The participants will be randomly&#xD;
      divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be&#xD;
      applied to Group 1 once.&#xD;
&#xD;
      And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at&#xD;
      night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3&#xD;
      weeks and hand wrist rest splints will be given for 3 months especially at night when it is&#xD;
      not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3&#xD;
      months, especially at night, when not using the hand. The evaluations will be repeated before&#xD;
      treatment, after the first week after treatment (first ESWT application) and at the 3rd&#xD;
      month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome&#xD;
      questionnaire, visual analog scale and dynamometer.&#xD;
&#xD;
      Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the&#xD;
      trial, the routine will not be excluded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal&#xD;
      shock wave therapy) and local corticosteroid injection compared to participants receiving&#xD;
      only splint and exercise therapy. And the investigators wanted to show that ESWT, a&#xD;
      noninvasive treatment modality, is as effective and reliable as local corticosteroid&#xD;
      injection, which is the least invasive treatment. Mild and moderate CTS patients will be&#xD;
      determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria.&#xD;
      Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid&#xD;
      treatment, fracture and trauma history of the treated side anterior arm and wrist,&#xD;
      inflammatory rheumatic disease, pregnant and lactating participants, participants with&#xD;
      cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet&#xD;
      syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or&#xD;
      unable to participate for any reason, and those who have been decided by the clinician that&#xD;
      the participants is not in favor of the participants, systemic diseases such as renal&#xD;
      failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90&#xD;
      idiopathic moderate and mild CTS participants will be included in the study. The participants&#xD;
      will be informed about their participation in a study and written informed consent will be&#xD;
      obtained.The demographic characteristics and disease duration of the participants will be&#xD;
      recorded. The participants will be randomly divided into 3 groups.40 mg of local&#xD;
      methylprednisolone (depomedrol) injection will be applied to Group 1 once.&#xD;
&#xD;
      And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at&#xD;
      night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3&#xD;
      weeks and hand wrist rest splints will be given for 3 months especially at night when it is&#xD;
      not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3&#xD;
      months, especially at night, when not using the hand. The evaluations will be repeated before&#xD;
      treatment, after the first week after treatment (first ESWT application) and at the 3rd&#xD;
      month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome&#xD;
      questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be&#xD;
      recorded before and 3 months after treatment. During the trial, the routine will not be&#xD;
      excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">May 29, 2019</completion_date>
  <primary_completion_date type="Actual">April 29, 2019</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) - Pain</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) - Numbness</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hand clamping force</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Hand grip strength measurement using Jamar hydraulic hand dynamometer. Hand grip strength measurements will be performed using the elbow at 90 degrees of flexion, while the forearm and wrist is in neutral position using resistance at level 2. Measurements shall be performed three times, and the average result shall be recorded in kilograms (kg) for each hand separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>boston scale</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Boston symptom severity score(SSS) and improvement in functional status score(FSS). There are 11 questions at SSS. Responses vary from 'none(1 point)' to 'very severe(5 points)'. There are 8 questions in FSS. Responses vary from 'very easy (1 point)' to 'very difficult (5 points) according to difficulty level. In both scales, the degree of symptom severity and dysfunction increases as the total score increases.The score of the patient is divided by the total score (total score is 11x5 = 55 for the SSS and the total score is 8x5 = 40 for FSS) and 0 to 1 for each patient. As this ratio reaches 1, the degree of symptom severity and dysfunction of the patient increases. For example; Considering that the total score obtained from all the questions in the SPS is 22, the ratio of 22/55 = 0. 4 is obtained.These scales will be applied after treatment and the rates obtained before and after treatment will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median nerve sensory distal latency(electrophysiological examination,physiological parameter)</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Evaluation of median nerve sensory distal latency: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. On EMG examination, sensory distal latency was greater than 3.6 ms and CTS was accepted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Evaluation of median nerve sensory transmission rate: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. Emotional nerve conduction velocity lower than 50 m/s in EMG examination will be accepted as CTS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median nerve motor distal latency( electrophysiological examination, physiological parameter)</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Evaluation of median nerve motor distal latency : The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. In the EMG examination, if the motor distal latency is over 4.2 ms, CTS will be accepted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Evaluation of median nerve motor transmission rate: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median sensory nerve action potential amplitude</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Evaluation of Median sensory nerve action potential amplitude: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. In the emg examination, the median sensory nerve action potential amplitude below 10 microvolts will be accepted as CTS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compound muscle action potential amplitude</measure>
    <time_frame>3. months after treatment</time_frame>
    <description>Evaluation of compound muscle action potential amplitude: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. The median CBAP amplitude below 5 millivolt in the recording of APB muscle in the emg examination will be accepted as CTS.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Tenosynovitis</condition>
  <arm_group>
    <arm_group_label>extracorporeal shock wave therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>carpal tunnel wrist brace</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day.&#xD;
Participants will use the carpal tunnel wrist brace 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>local injection</intervention_name>
    <description>In addition to the local injection, carpal tunnel brace will be given.</description>
    <arm_group_label>local injection</arm_group_label>
    <other_name>local corticosteroid injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>extracorporeal shock wave therapy</intervention_name>
    <description>In addition to all ESWT participants, carpal tunnel brace will be given.</description>
    <arm_group_label>extracorporeal shock wave therapy</arm_group_label>
    <other_name>physiotheraphy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis&#xD;
             diagnosed between 18-65 years of age with clinical and EMG.&#xD;
&#xD;
          2. Patients who are able to understand and correctly understand the patient information&#xD;
             form&#xD;
&#xD;
          3. Patients consenting to participate in the study according to the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cervical radiculopathy&#xD;
&#xD;
          2. Polyneuropathy&#xD;
&#xD;
          3. Brachial plexopathy&#xD;
&#xD;
          4. Systemic corticosteroid treatment&#xD;
&#xD;
          5. Fracture and trauma history of the treated side anterior arm and wrist&#xD;
&#xD;
          6. Inflammatory rheumatic disease&#xD;
&#xD;
          7. Pregnant and lactating patients&#xD;
&#xD;
          8. Patients with cardiac pacemakers&#xD;
&#xD;
          9. Patients undergoing carpal tunnel syndrome surgery&#xD;
&#xD;
         10. Thoracic outlet syndrome&#xD;
&#xD;
         11. Severe atrophy&#xD;
&#xD;
         12. Severe carpal tunnel syndrome&#xD;
&#xD;
         13. Patients who are unwilling or unable to participate for any reason, and those who have&#xD;
             been decided by the clinician that the patient is not in favor of the patient,&#xD;
&#xD;
         14. Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation&#xD;
             disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Havva ÖZTÜRK DURMAZ</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ahi Evran University Education and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahi Evran University Education and Research Hospital</name>
      <address>
        <city>Kırşehir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ahi Evran University Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Havva Öztürk Durmaz</investigator_full_name>
    <investigator_title>Research Assistant Doctor Havva ÖZTÜRK DURMAZ</investigator_title>
  </responsible_party>
  <keyword>extracorporeal shock wave therapy</keyword>
  <keyword>corticosteroid injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenosynovitis</mesh_term>
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03792945
org study id: AhiEvranUERH
nct id: NCT03792945
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal
      shock wave therapy) and local corticosteroid injection in patients with carpal tunnel
      syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the
      investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and
      reliable as local corticosteroid injection, which is the least invasive treatment. Mild and
      moderate CTS patients will be determined according to American Association of
      Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will
      be included in the study. The participants will be informed about their participation in a
      study and written informed consent will be obtained.The demographic characteristics and
      disease duration of the participants will be recorded.The participants will be randomly
      divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be
      applied to Group 1 once.

      And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at
      night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3
      weeks and hand wrist rest splints will be given for 3 months especially at night when it is
      not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3
      months, especially at night, when not using the hand. The evaluations will be repeated before
      treatment, after the first week after treatment (first ESWT application) and at the 3rd
      month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome
      questionnaire, visual analog scale and dynamometer.

      Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the
      trial, the routine will not be excluded.
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal
      shock wave therapy) and local corticosteroid injection compared to participants receiving
      only splint and exercise therapy. And the investigators wanted to show that ESWT, a
      noninvasive treatment modality, is as effective and reliable as local corticosteroid
      injection, which is the least invasive treatment. Mild and moderate CTS patients will be
      determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria.
      Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid
      treatment, fracture and trauma history of the treated side anterior arm and wrist,
      inflammatory rheumatic disease, pregnant and lactating participants, participants with
      cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet
      syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or
      unable to participate for any reason, and those who have been decided by the clinician that
      the participants is not in favor of the participants, systemic diseases such as renal
      failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90
      idiopathic moderate and mild CTS participants will be included in the study. The participants
      will be informed about their participation in a study and written informed consent will be
      obtained.The demographic characteristics and disease duration of the participants will be
      recorded. The participants will be randomly divided into 3 groups.40 mg of local
      methylprednisolone (depomedrol) injection will be applied to Group 1 once.

      And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at
      night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3
      weeks and hand wrist rest splints will be given for 3 months especially at night when it is
      not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3
      months, especially at night, when not using the hand. The evaluations will be repeated before
      treatment, after the first week after treatment (first ESWT application) and at the 3rd
      month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome
      questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be
      recorded before and 3 months after treatment. During the trial, the routine will not be
      excluded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analog Scale (VAS) - Pain
time frame: 3. months after treatment
description: VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.
measure: Visual Analog Scale (VAS) - Numbness
time frame: 3. months after treatment
description: VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.
measure: hand clamping force
time frame: 3. months after treatment
description: Hand grip strength measurement using Jamar hydraulic hand dynamometer. Hand grip strength measurements will be performed using the elbow at 90 degrees of flexion, while the forearm and wrist is in neutral position using resistance at level 2. Measurements shall be performed three times, and the average result shall be recorded in kilograms (kg) for each hand separately.
measure: boston scale
time frame: 3. months after treatment
description: Boston symptom severity score(SSS) and improvement in functional status score(FSS). There are 11 questions at SSS. Responses vary from 'none(1 point)' to 'very severe(5 points)'. There are 8 questions in FSS. Responses vary from 'very easy (1 point)' to 'very difficult (5 points) according to difficulty level. In both scales, the degree of symptom severity and dysfunction increases as the total score increases.The score of the patient is divided by the total score (total score is 11x5 = 55 for the SSS and the total score is 8x5 = 40 for FSS) and 0 to 1 for each patient. As this ratio reaches 1, the degree of symptom severity and dysfunction of the patient increases. For example; Considering that the total score obtained from all the questions in the SPS is 22, the ratio of 22/55 = 0. 4 is obtained.These scales will be applied after treatment and the rates obtained before and after treatment will be compared.
measure: Median nerve sensory distal latency(electrophysiological examination,physiological parameter)
time frame: 3. months after treatment
description: Evaluation of median nerve sensory distal latency: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. On EMG examination, sensory distal latency was greater than 3.6 ms and CTS was accepted.
measure: Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)
time frame: 3. months after treatment
description: Evaluation of median nerve sensory transmission rate: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. Emotional nerve conduction velocity lower than 50 m/s in EMG examination will be accepted as CTS.
measure: Median nerve motor distal latency( electrophysiological examination, physiological parameter)
time frame: 3. months after treatment
description: Evaluation of median nerve motor distal latency : The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. In the EMG examination, if the motor distal latency is over 4.2 ms, CTS will be accepted.
measure: Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)
time frame: 3. months after treatment
description: Evaluation of median nerve motor transmission rate: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist.
measure: Median sensory nerve action potential amplitude
time frame: 3. months after treatment
description: Evaluation of Median sensory nerve action potential amplitude: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. In the emg examination, the median sensory nerve action potential amplitude below 10 microvolts will be accepted as CTS.
measure: Compound muscle action potential amplitude
time frame: 3. months after treatment
description: Evaluation of compound muscle action potential amplitude: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. The median CBAP amplitude below 5 millivolt in the recording of APB muscle in the emg examination will be accepted as CTS.
arm group label: extracorporeal shock wave therapy
arm group type: Active Comparator
description: ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.
arm group label: local injection
arm group type: Active Comparator
description: 40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.
arm group label: carpal tunnel wrist brace
arm group type: No Intervention
description: Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day.
Participants will use the carpal tunnel wrist brace 3 months.
intervention type: Drug
intervention name: local injection
description: In addition to the local injection, carpal tunnel brace will be given.
arm group label: local injection
other name: local corticosteroid injection
intervention type: Device
intervention name: extracorporeal shock wave therapy
description: In addition to all ESWT participants, carpal tunnel brace will be given.
arm group label: extracorporeal shock wave therapy
other name: physiotheraphy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Havva ÖZTÜRK DURMAZ
role: Principal Investigator
affiliation: Ahi Evran University Education and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ahi Evran University Education and Research Hospital
investigator full name: Havva Öztürk Durmaz
investigator title: Research Assistant Doctor Havva ÖZTÜRK DURMAZ
mesh term: Tenosynovitis
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
sharing ipd: No