xml: <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/NCT05995639</url>
    </required_header>
    <id_info>
      <org_study_id>DnvsO</org_study_id>
      <nct_id>NCT05995639</nct_id>
    </id_info>
    <brief_title>Dry Needling Versus Ozone in Myofascial Pain Syndrome</brief_title>
    <official_title>Comparison of the Effects of Dry Needling and Ozone Treatment on Pain and Functionality in Myofascial Pain Syndrome of the Upper Trapezius</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar State Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar State 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>
        The aim of this study is to compare the effects of dry needling treatment (DN) and ozone&#xD;
        treatment on pain and functionality in individuals with myofascial pain syndrome affecting&#xD;
        the upper trapezius (UT) region.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this prospective randomized study to be conducted in Üsküdar state hospital, patients&#xD;
        diagnosed with myofascial pain syndrome in the upper part of the trapezius muscle will be&#xD;
        divided into 3 groups. 1st group patients will be given stretching exercises for the upper&#xD;
        part of the trapezius muscle. The exercise program will last 15 days. In addition to exercise&#xD;
        therapy, the 2nd group will receive dry needling treatment using acupuncture needles of 0.25&#xD;
        x 25mm in size by a physical medicine and rehabilitation specialist with 5 years of&#xD;
        experience in the field. Active trigger points will be treated. Trigger points will be&#xD;
        diagnosed according to the criteria determined by Simons and Travell. Dry needling treatment&#xD;
        will be applied in 3 sessions, one week apart. In the 3rd group, in addition to exercise&#xD;
        therapy, 10 gamma ozone will be applied in a total of 3 sessions, one week apart to the upper&#xD;
        part of the trapezius muscle by a physical therapist with 10 years of experience in the&#xD;
        field. Patients will be evaluated at the beginning of the treatment, after 1 week, at the 3rd&#xD;
        week, and after 1 month.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 2, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>
      <intervention_model_description>In this prospective randomized study to be conducted in Üsküdar state hospital, patients diagnosed with myofascial pain syndrome in the upper part of the trapezius muscle will be divided into 3 equal groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Investigators and outcomes assessors will be blinded to the procedures.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain measured by Visual Analog Scale</measure>
      <time_frame>First day, after first week, after three weeks, after one month</time_frame>
      <description>The Visual Analog Scale (VAS) is a widely used pain assessment tool in clinical settings. It involves a simple linear scale typically ranging from 0 to 10, where individuals mark a point to indicate their pain intensity level. The left end of the scale represents &quot;no pain,&quot; assigned a value of 0, while the right end corresponds to &quot;worst possible pain,&quot; denoted as 10. By gauging pain subjectively through this visual representation, the VAS provides a quantifiable measure of pain intensity, enabling healthcare professionals to track changes in pain over time and tailor treatment strategies accordingly.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Life Measured by Neck Disability Index</measure>
      <time_frame>First day, after first week, after three weeks, after one month</time_frame>
      <description>The Neck Disability Index (NDI) is a widely used tool to assess the impact of neck-related conditions on an individual's quality of life. It consists of a questionnaire that comprises ten items, each addressing different aspects of daily functioning and discomfort related to neck pain. Participants rate their level of difficulty in various activities such as lifting, reading, and sleeping on a scale from 0 to 5. The total score is then calculated and expressed as a percentage, providing valuable insights into the extent of neck-related disability and its effect on overall quality of life. The NDI aids clinicians in evaluating treatment outcomes, designing intervention plans, and monitoring improvements in neck-related functionality.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Range of Motion Measured by Goniometer</measure>
      <time_frame>First day, after first week, after three weeks, after one month</time_frame>
      <description>A goniometer is a standard instrument used to measure the range of motion (ROM) of the neck joints. It consists of arms and a protractor that allows clinicians to precisely quantify the angles achieved during various neck movements. During assessment, the patient is guided through specific motions like flexion, extension, rotation, and lateral bending, while the goniometer's arms are aligned with the corresponding body landmarks. The resulting measurements provide objective data about the neck's flexibility and mobility, aiding healthcare professionals in diagnosing musculoskeletal conditions, planning treatment strategies, and tracking progress over time.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Dry Needling</condition>
    <condition>Ozone</condition>
    <condition>Trapezius</condition>
    <condition>Trigger Point Pain, Myofascial</condition>
    <condition>Myofascial Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients who will undergo an exercise treatment for the UT. The exercise therapy will focus on stretching exercises for the UT. Exercise therapy will undergo 2 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry Needling Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who will undergo DN treatment for the UT. A clinician with 5 years of DN experience will assess patients and apply DN treatment. The active trigger points will be diagnosed by the criteria described by Simons and Travell. 0.25x25mm acupuncture needles will be used. DN will be performed with fast in fast out technique and needling will continue until a local twitch response is elicited. Treatment will be applied 3 times, one week apart.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ozone Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who will undergo ozone treatment for the UT. A clinician with 10 years of ozone experience will assess patients and apply ozone treatment. 12 gamma ozone will be used. Patients will be injected with ozone in UT with most sensitive parts. Treatment will be applied 3 times, one week apart.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dry Needling</intervention_name>
      <description>Dry needling is an evidence-based therapeutic procedure used primarily in musculoskeletal rehabilitation. It involves inserting thin needles into specific trigger points in muscles, tendons, or fascia, aiming to alleviate pain and improve musculoskeletal function. Unlike acupuncture, dry needling focuses on resolving myofascial pain and dysfunction by directly targeting trigger points, often identified through palpation and anatomical understanding. Academic exploration of dry needling delves into its physiological mechanisms, clinical effectiveness, and potential integration into comprehensive treatment strategies.</description>
      <arm_group_label>Dry Needling Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ozone Injection</intervention_name>
      <description>Intramuscular ozone injection is a therapeutic intervention utilized within the context of musculoskeletal care, particularly for individuals grappling with conditions such as myofascial pain syndrome and related neuromuscular issues. This technique involves the controlled introduction of ozone gas, a chemically reactive form of oxygen, directly into targeted muscle tissue through an injection. This intramuscular administration is guided by precise anatomical knowledge and is designed to harness the potential therapeutic benefits of ozone's reactive properties.</description>
      <arm_group_label>Ozone Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Adults (18-65 years) with diagnosed myofascial pain syndrome affecting the upper trapezius&#xD;
          area Willing and able to provide informed consent Able to comprehend and complete&#xD;
          study-related assessments Diagnosed with myofascial pain syndrome affecting the upper&#xD;
          trapezius area, based on clinical assessment and Simons and Travell criteria No prior&#xD;
          exposure to dry needling or ozone therapy for myofascial pain syndrome Medically stable and&#xD;
          cleared by a physician for study participation No active musculoskeletal injuries or&#xD;
          conditions in the upper trapezius area No participation in similar interventions within the&#xD;
          last 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Individuals with known contraindications to dry needling or ozone therapy Severe&#xD;
          cardiovascular conditions or uncontrolled hypertension Active infections or skin conditions&#xD;
          at treatment sites Known bleeding disorders or anticoagulant use Diagnosed with any other&#xD;
          chronic pain syndrome not related to myofascial pain syndrome Any ongoing litigation or&#xD;
          compensation claims related to pain conditions Recent trauma or surgery in the upper&#xD;
          trapezius area Previous adverse reactions to dry needling or ozone therapy Participation in&#xD;
          other investigational studies within the last 3 months History of psychological conditions&#xD;
          that might interfere with assessment Pregnant or breastfeeding History of malignancy or&#xD;
          immunocompromised status Neurological disorders affecting upper trapezius function Severe&#xD;
          cognitive impairments that hinder assessment Inability to commit to the study duration or&#xD;
          follow-up assessments Any change in medication regimen that might impact pain or&#xD;
          functionality during the study period&#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>Mustafa H Temel, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Uskudar State Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mustafa H Temel, M.D.</last_name>
      <phone>+905342714872</phone>
      <email>mhuseyintemel@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar State Hospital</investigator_affiliation>
      <investigator_full_name>Mustafa Hüseyin Temel</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The individual participant data will be shared upon reasonable request by the principal investigator upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>1 day</ipd_time_frame>
      <ipd_access_criteria>The individual participant data will be shared upon reasonable request by the principal investigator upon reasonable request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995639
  org study id: DnvsO
  nct id: NCT05995639
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to compare the effects of dry needling treatment (DN) and ozone
        treatment on pain and functionality in individuals with myofascial pain syndrome affecting
        the upper trapezius (UT) region.
  In this prospective randomized study to be conducted in Üsküdar state hospital, patients
        diagnosed with myofascial pain syndrome in the upper part of the trapezius muscle will be
        divided into 3 groups. 1st group patients will be given stretching exercises for the upper
        part of the trapezius muscle. The exercise program will last 15 days. In addition to exercise
        therapy, the 2nd group will receive dry needling treatment using acupuncture needles of 0.25
        x 25mm in size by a physical medicine and rehabilitation specialist with 5 years of
        experience in the field. Active trigger points will be treated. Trigger points will be
        diagnosed according to the criteria determined by Simons and Travell. Dry needling treatment
        will be applied in 3 sessions, one week apart. In the 3rd group, in addition to exercise
        therapy, 10 gamma ozone will be applied in a total of 3 sessions, one week apart to the upper
        part of the trapezius muscle by a physical therapist with 10 years of experience in the
        field. Patients will be evaluated at the beginning of the treatment, after 1 week, at the 3rd
        week, and after 1 month.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In this prospective randomized study to be conducted in Üsküdar state hospital, patients diagnosed with myofascial pain syndrome in the upper part of the trapezius muscle will be divided into 3 equal groups.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Investigators and outcomes assessors will be blinded to the procedures.
  measure: Pain measured by Visual Analog Scale
  time frame: First day, after first week, after three weeks, after one month
  description: The Visual Analog Scale (VAS) is a widely used pain assessment tool in clinical settings. It involves a simple linear scale typically ranging from 0 to 10, where individuals mark a point to indicate their pain intensity level. The left end of the scale represents "no pain," assigned a value of 0, while the right end corresponds to "worst possible pain," denoted as 10. By gauging pain subjectively through this visual representation, the VAS provides a quantifiable measure of pain intensity, enabling healthcare professionals to track changes in pain over time and tailor treatment strategies accordingly.
  measure: Quality of Life Measured by Neck Disability Index
  time frame: First day, after first week, after three weeks, after one month
  description: The Neck Disability Index (NDI) is a widely used tool to assess the impact of neck-related conditions on an individual's quality of life. It consists of a questionnaire that comprises ten items, each addressing different aspects of daily functioning and discomfort related to neck pain. Participants rate their level of difficulty in various activities such as lifting, reading, and sleeping on a scale from 0 to 5. The total score is then calculated and expressed as a percentage, providing valuable insights into the extent of neck-related disability and its effect on overall quality of life. The NDI aids clinicians in evaluating treatment outcomes, designing intervention plans, and monitoring improvements in neck-related functionality.
  measure: Range of Motion Measured by Goniometer
  time frame: First day, after first week, after three weeks, after one month
  description: A goniometer is a standard instrument used to measure the range of motion (ROM) of the neck joints. It consists of arms and a protractor that allows clinicians to precisely quantify the angles achieved during various neck movements. During assessment, the patient is guided through specific motions like flexion, extension, rotation, and lateral bending, while the goniometer's arms are aligned with the corresponding body landmarks. The resulting measurements provide objective data about the neck's flexibility and mobility, aiding healthcare professionals in diagnosing musculoskeletal conditions, planning treatment strategies, and tracking progress over time.
  arm group label: Control Group
  arm group type: No Intervention
  description: Patients who will undergo an exercise treatment for the UT. The exercise therapy will focus on stretching exercises for the UT. Exercise therapy will undergo 2 weeks.
  arm group label: Dry Needling Group
  arm group type: Active Comparator
  description: Patients who will undergo DN treatment for the UT. A clinician with 5 years of DN experience will assess patients and apply DN treatment. The active trigger points will be diagnosed by the criteria described by Simons and Travell. 0.25x25mm acupuncture needles will be used. DN will be performed with fast in fast out technique and needling will continue until a local twitch response is elicited. Treatment will be applied 3 times, one week apart.
  arm group label: Ozone Group
  arm group type: Active Comparator
  description: Patients who will undergo ozone treatment for the UT. A clinician with 10 years of ozone experience will assess patients and apply ozone treatment. 12 gamma ozone will be used. Patients will be injected with ozone in UT with most sensitive parts. Treatment will be applied 3 times, one week apart.
  intervention type: Procedure
  intervention name: Dry Needling
  description: Dry needling is an evidence-based therapeutic procedure used primarily in musculoskeletal rehabilitation. It involves inserting thin needles into specific trigger points in muscles, tendons, or fascia, aiming to alleviate pain and improve musculoskeletal function. Unlike acupuncture, dry needling focuses on resolving myofascial pain and dysfunction by directly targeting trigger points, often identified through palpation and anatomical understanding. Academic exploration of dry needling delves into its physiological mechanisms, clinical effectiveness, and potential integration into comprehensive treatment strategies.
  arm group label: Dry Needling Group
  intervention type: Procedure
  intervention name: Ozone Injection
  description: Intramuscular ozone injection is a therapeutic intervention utilized within the context of musculoskeletal care, particularly for individuals grappling with conditions such as myofascial pain syndrome and related neuromuscular issues. This technique involves the controlled introduction of ozone gas, a chemically reactive form of oxygen, directly into targeted muscle tissue through an injection. This intramuscular administration is guided by precise anatomical knowledge and is designed to harness the potential therapeutic benefits of ozone's reactive properties.
  arm group label: Ozone Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Mustafa H Temel, M.D.
  role: Principal Investigator
  affiliation: Uskudar State Hospital
  last name: Mustafa H Temel, M.D.
  phone: +905342714872
  email: mhuseyintemel@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar State Hospital
  investigator full name: Mustafa Hüseyin Temel
  investigator title: Principal Investigator
  mesh term: Myofascial Pain Syndromes
  mesh term: Fibromyalgia
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: Yes
  ipd description: The individual participant data will be shared upon reasonable request by the principal investigator upon reasonable request.
  ipd info type: Study Protocol
  ipd time frame: 1 day
  ipd access criteria: The individual participant data will be shared upon reasonable request by the principal investigator upon reasonable request.