<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/NCT04405453</url>
  </required_header>
  <id_info>
    <org_study_id>DiskapiTRH Algology</org_study_id>
    <nct_id>NCT04405453</nct_id>
  </id_info>
  <brief_title>Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome</brief_title>
  <official_title>Contribution of Erector Spina Plane Block to Analgesia Combined With Ultrasound Guided Trapezius Muscle Injection for Myofascial Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Teaching and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Teaching and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in&#xD;
      one or more muscle groups. It is characterized by myofascial trigger points that are felt as&#xD;
      a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger&#xD;
      points are developes as a result of muscle injury ; this can be acute trauma caused by sport&#xD;
      injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional&#xD;
      stress or poor posture. Trigger point injection is the application of low dose local&#xD;
      anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused&#xD;
      by muscle spasm.However, it may reduce pain partially or have a short duration of action, so&#xD;
      it may need to be repeated several times at regular intervals.Trigger point injection can&#xD;
      reach trigger points in superficial muscles With the erector spina plane block technique,&#xD;
      more effective and long-term pain treatment can be achieved by reaching deeper trigger&#xD;
      points. With this hypothesis, we aimed to investigate the contribution of the erector spina&#xD;
      plane block to trigger point injection in the treatment of myofascial pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in&#xD;
      one or more muscle groups. It is characterized by myofascial trigger points that are felt as&#xD;
      a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger&#xD;
      points are developes as a result of muscle injury ; this can be acute trauma caused by sport&#xD;
      injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional&#xD;
      stress or poor posture. Trigger point injection is the application of low dose local&#xD;
      anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused&#xD;
      by muscle spasm.However, it may reduce pain partially or have a short duration of action, so&#xD;
      it may need to be repeated several times at regular intervals.Trigger point injection can&#xD;
      reach trigger points in superficial muscles With the erector spina plane block technique,&#xD;
      more effective and long-term pain treatment can be achieved by reaching deeper trigger&#xD;
      points. With this hypothesis, we aimed to investigate the contribution of the erector spina&#xD;
      plane block to trigger point injection in the treatment of myofascial pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 5, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Patients with myofasial pain syndrome will randomized into two group. TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive. Pain severity of the patients will evaluate by visual analog scale. Datas will obtaine before (week 0) and after (week 1,2,3,4) the injections.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>One physician who will be blind will examinade all patients for eligibility and will valuate the outcome measures although the physician who will performe all injections will not be blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>VAS (visual analog scale ) score</measure>
    <time_frame>before injection (week 0)</time_frame>
    <description>Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS (visual analog scale ) score</measure>
    <time_frame>1st week after injection</time_frame>
    <description>Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS (visual analog scale ) score</measure>
    <time_frame>2nd week after injection</time_frame>
    <description>Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS (visual analog scale ) score</measure>
    <time_frame>3rd week after injection</time_frame>
    <description>Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS (visual analog scale ) score</measure>
    <time_frame>4th weeks after injection</time_frame>
    <description>Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Trigger Point</condition>
  <condition>Myofascial Pain</condition>
  <arm_group>
    <arm_group_label>Trapezius Muscle İnjection (TMI) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erector Spina Plane Block (ESPB) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive. Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>trapezius muscle injection</intervention_name>
    <description>TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.</description>
    <arm_group_label>Erector Spina Plane Block (ESPB) group</arm_group_label>
    <arm_group_label>Trapezius Muscle İnjection (TMI) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>erector spina plane block</intervention_name>
    <description>1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive</description>
    <arm_group_label>Erector Spina Plane Block (ESPB) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of Myofascial pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cervical radiculopathy fibromyalgia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>damla yürük</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diskapi Teaching and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ömer taylan akkaya</last_name>
    <role>Study Director</role>
    <affiliation>Diskapi Teaching and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hüseyin Alp Alptekin</last_name>
    <role>Study Chair</role>
    <affiliation>Diskapi Teaching and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dişkapi Reserch and Education Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
    <investigator_full_name>Damla Yürük</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Trigger point , Erector spinae plane block , Ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>19.05.2020</ipd_time_frame>
    <ipd_access_criteria>NO CRİTERİA</ipd_access_criteria>
  </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/NCT04405453
org study id: DiskapiTRH Algology
nct id: NCT04405453
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in
      one or more muscle groups. It is characterized by myofascial trigger points that are felt as
      a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger
      points are developes as a result of muscle injury ; this can be acute trauma caused by sport
      injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional
      stress or poor posture. Trigger point injection is the application of low dose local
      anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused
      by muscle spasm.However, it may reduce pain partially or have a short duration of action, so
      it may need to be repeated several times at regular intervals.Trigger point injection can
      reach trigger points in superficial muscles With the erector spina plane block technique,
      more effective and long-term pain treatment can be achieved by reaching deeper trigger
      points. With this hypothesis, we aimed to investigate the contribution of the erector spina
      plane block to trigger point injection in the treatment of myofascial pain.
Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in
      one or more muscle groups. It is characterized by myofascial trigger points that are felt as
      a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger
      points are developes as a result of muscle injury ; this can be acute trauma caused by sport
      injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional
      stress or poor posture. Trigger point injection is the application of low dose local
      anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused
      by muscle spasm.However, it may reduce pain partially or have a short duration of action, so
      it may need to be repeated several times at regular intervals.Trigger point injection can
      reach trigger points in superficial muscles With the erector spina plane block technique,
      more effective and long-term pain treatment can be achieved by reaching deeper trigger
      points. With this hypothesis, we aimed to investigate the contribution of the erector spina
      plane block to trigger point injection in the treatment of myofascial pain.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Patients with myofasial pain syndrome will randomized into two group. TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive. Pain severity of the patients will evaluate by visual analog scale. Datas will obtaine before (week 0) and after (week 1,2,3,4) the injections.
primary purpose: Treatment
masking: Single (Investigator)
masking description: One physician who will be blind will examinade all patients for eligibility and will valuate the outcome measures although the physician who will performe all injections will not be blind.
measure: VAS (visual analog scale ) score
time frame: before injection (week 0)
description: Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
measure: VAS (visual analog scale ) score
time frame: 1st week after injection
description: Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
measure: VAS (visual analog scale ) score
time frame: 2nd week after injection
description: Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
measure: VAS (visual analog scale ) score
time frame: 3rd week after injection
description: Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
measure: VAS (visual analog scale ) score
time frame: 4th weeks after injection
description: Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
arm group label: Trapezius Muscle İnjection (TMI) group
arm group type: Active Comparator
description: TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections
arm group label: Erector Spina Plane Block (ESPB) group
arm group type: Active Comparator
description: ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive. Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections
intervention type: Procedure
intervention name: trapezius muscle injection
description: TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
arm group label: Erector Spina Plane Block (ESPB) group
arm group label: Trapezius Muscle İnjection (TMI) group
intervention type: Procedure
intervention name: erector spina plane block
description: 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive
arm group label: Erector Spina Plane Block (ESPB) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: damla yürük
role: Principal Investigator
affiliation: Diskapi Teaching and Research Hospital
last name: ömer taylan akkaya
role: Study Director
affiliation: Diskapi Teaching and Research Hospital
last name: Hüseyin Alp Alptekin
role: Study Chair
affiliation: Diskapi Teaching and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Diskapi Teaching and Research Hospital
investigator full name: Damla Yürük
investigator title: MD
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia
sharing ipd: Yes
ipd description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 19.05.2020
ipd access criteria: NO CRİTERİA