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/NCT06012786</url>
    </required_header>
    <id_info>
      <org_study_id>23/338</org_study_id>
      <nct_id>NCT06012786</nct_id>
    </id_info>
    <brief_title>Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema</brief_title>
    <official_title>Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</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 goal of this observational study is to determine the relationship between Lymphedema and&#xD;
        Myofascial Pain Syndrome in Breast Cancer Patients.&#xD;
  &#xD;
        The main questions it aims to answer:&#xD;
  &#xD;
          -  Is there a relationship between the stage of lymphedema and the frequency of&#xD;
             accompanying myofascial pain syndrome in the breast cancer patients?&#xD;
  &#xD;
          -  Does the existence of lymphedema in breast cancer patients affect the distribution and&#xD;
             the pain threshold values of trigger points seen in Myofascial Pain Syndrome?&#xD;
  &#xD;
          -  What is the impact of Myofascial pain syndrome seen in breast cancer associted lymhedema&#xD;
             patients on upper extremity function and quality of life?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mastectomy, breast conserving surgery, axillary lymph node dissection, sentinel lymph node&#xD;
        biopsy and radiotherapy treatments have significant results in skin, muscle and fascia&#xD;
        tissues in the upper extremity.&#xD;
  &#xD;
        Upper extremity function is defined by the International Consortium for Measures of Health&#xD;
        Outcomes (ICHOM) as one of the most important health measures in breast cancer patients.&#xD;
        Long-term upper extremity dysfunction has serious effects on patients' quality of life.&#xD;
  &#xD;
        Lymphedema, severe pain, decrease in shoulder joint range of motion, myofascial pain&#xD;
        syndrome, myofascial adhesions are the leading causes affecting upper extremity function in&#xD;
        patients with breast cancer.&#xD;
  &#xD;
        Myofascial pain syndrome (MPS) is commonly seen in patients with musculoskeletal problems and&#xD;
        originates from muscle and surrounding tissues. It is characterized by localized or referred&#xD;
        pain in a limited area and trigger points in the affected muscles. The incidence of&#xD;
        myofascial pain syndrome secondary to breast cancer surgery is unknown. There is not yet a&#xD;
        study in the literature that reveals the relationship between the stage of lymphedema and the&#xD;
        frequency of accompanying myofascial pain syndrome in the breast cancer patients.&#xD;
  &#xD;
        This study is designed as cross sectional- single centered and single blind. It is planned to&#xD;
        include 110 breast cancer patients who had undergone the treatments as mastectomy, breast&#xD;
        conserving surgery, lymph node dissection, sentinele lymph node biopsy or radiotherapy aged&#xD;
        between 18-75 years-old, visiting our oncological rehabilitation outpatient clinic August&#xD;
        2023 through May 2024.&#xD;
  &#xD;
        Patients will be divided into 2 groups according to the stage of lymphedema. It is known that&#xD;
        pathophysiological changes develop even if there is no visible lymphedema in patients&#xD;
        undergoing surgery and/or radiotherapy for breast cancer. There is a lifetime risk of&#xD;
        developing lymphedema, so these patients are considered as Stage 0 (latent) . The patients&#xD;
        with less than 3 cm difference between the circumference measurements of upper extremities&#xD;
        will be included in the 1st group.( Stage 0) (n=55) Patients who have more than 3 cm&#xD;
        difference between the circumference measurements of upper extremities and those with Stage&#xD;
        1,2 or 3 lymphedema will be included in the second group (n=55) The frequency of myofascial&#xD;
        pain syndrome will be determined by the diagnostic criterias in both groups. The trigger&#xD;
        points in trapezius, infraspinatus, serratus anterior, latissimus dorsi and pectoralis major&#xD;
        muscles will be examined and the pain-pressure threshold values will be measured with an&#xD;
        algometer.&#xD;
  &#xD;
        For the evaluation of upper extremity function and quality of life following measurement&#xD;
        tools will be utilized in both groups: Hand-grip test with a dynamometer, goniometric&#xD;
        measurement of range of motion (ROM) of shoulder joint, VAS numerical scales, LYMQOL and DASH&#xD;
        questionnaires.&#xD;
  &#xD;
        Data analysis will be performed by using the Statistical Package for the Social Sciences&#xD;
        (SPSS, version 20.0, IBM Corp., Armonk, NY, USA).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The Evaluation of Trigger Points</measure>
      <time_frame>3 days</time_frame>
      <description>Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Diagnostic Criteria of Myofascial Pain Syndrome</measure>
      <time_frame>3 days</time_frame>
      <description>Major criteria: 1. The patient's complaint of regional pain 2. Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point 3. Presence of palpable taut band 4. Presence of palpable and tender points along the length of the taut band 5. Restriction of ROM in the area of the affected muscle Minor criteria: 1. Pain/sensory change with pressure palpation of the trigger point 2. Local twitch response with palpation/injection of the trigger point in the taut band 3. Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hand Grip Test</measure>
      <time_frame>3 days</time_frame>
      <description>The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion of shoulder joint</measure>
      <time_frame>3 days</time_frame>
      <description>Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS</measure>
      <time_frame>3 days</time_frame>
      <description>Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quick-DASH (The Disabilities of the Arm, Shoulder and Hand)</measure>
      <time_frame>3 days</time_frame>
      <description>The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LYMQOL-arm (Lymphedema Quality of Life -arm)</measure>
      <time_frame>3 days</time_frame>
      <description>Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Myofascial Pain Syndrome</condition>
    <condition>Breast Cancer</condition>
    <condition>Breast Cancer Female</condition>
    <condition>Lymphedema</condition>
    <condition>Lymphedema of Upper Limb</condition>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <description>It is known that pathophysiological changes develop even if there is no visible lymphedema in patients undergoing surgery and/or radiotherapy for breast cancer. There is a lifetime risk of developing lymphedema, so these patients are considered as Stage 0 (latent). The patients with less than 3 cm difference between the circumference measurements of upper extremities will be included in the 1st group.( Stage 0) (n=55)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
      <description>Patients who have more than 3 cm difference between the circumference measurements of upper extremities and those with Stage 1,2 or 3 lymphedema will be included in the second group (n=55)</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnostic Criteria of Myofascial Pain Syndrome</intervention_name>
      <description>Major criteria:&#xD;
  The patient's complaint of regional pain&#xD;
  Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point&#xD;
  Presence of palpable taut band&#xD;
  Presence of palpable and tender points along the length of the taut band&#xD;
  Restriction of ROM in the area of the affected muscle&#xD;
  Minor criteria:&#xD;
  Pain/sensory change with pressure palpation of the trigger point&#xD;
  Local twitch response with palpation/injection of the trigger point in the taut band&#xD;
  Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer</intervention_name>
      <description>Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Hand Grip Test</intervention_name>
      <description>The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>VAS</intervention_name>
      <description>Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Quick DASH</intervention_name>
      <description>The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Lymqol-Arm</intervention_name>
      <description>Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Range of Motion of Shoulde Joint</intervention_name>
      <description>Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.</description>
      <arm_group_label>Group 1 (Patients with Stage 0 lymphedema)</arm_group_label>
      <arm_group_label>Group 2 (Patients with Stage 1,2 or 3 lymphedema)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Breast Cancer patients aged between 18-75 years old, who had undergone the treatments as&#xD;
          mastectomy, breast conserving surgery, lymph node dissection, sentinele lymph node biopsy&#xD;
          or radiotherapy visiting our oncological rehabilitation outpatient clinic between August&#xD;
          2023 and May 2024.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria :&#xD;
  &#xD;
            -  Breast cancer patients aged between 18-75 who had undergone the treatments as&#xD;
               mastectomy, breast conserving surgery, lymph node dissection, sentinele lymph node&#xD;
               biopsy or radiotherapy providing a written consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria :&#xD;
  &#xD;
            -  Patients who do not agree to participate the study&#xD;
  &#xD;
            -  Patients who had signs of active infection as lymphangitis, cellulitis, fungus&#xD;
  &#xD;
            -  Bilateral breast cancer patients&#xD;
  &#xD;
            -  Uncontrolled Psychiatric illness&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female Breast Cancer Patients</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yeliz Bahar Özdemir</last_name>
      <role>Principal Investigator</role>
    </overall_official>
    <overall_contact>
      <last_name>Özden Tömek, MD</last_name>
      <phone>Turkey: +905343284941</phone>
      <email>ozden.tomek@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gökçenur Yalçın, MD</last_name>
      <phone>+905301413290</phone>
      <email>gokce_cihaner@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sultan 2. Abdulhamid Han Training and Research Hospital</name>
        <address>
          <city>İstanbul</city>
          <state>Kadıköy</state>
          <zip>34668</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>myofascial pain syndrome</keyword>
    <keyword>lymphedema</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Lymphedema</mesh_term>
      <mesh_term>Breast Cancer Lymphedema</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Undecided</ipd_description>
    </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/NCT06012786
  org study id: 23/338
  nct id: NCT06012786
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to determine the relationship between Lymphedema and
        Myofascial Pain Syndrome in Breast Cancer Patients.
  
        The main questions it aims to answer:
  
          -  Is there a relationship between the stage of lymphedema and the frequency of
             accompanying myofascial pain syndrome in the breast cancer patients?
  
          -  Does the existence of lymphedema in breast cancer patients affect the distribution and
             the pain threshold values of trigger points seen in Myofascial Pain Syndrome?
  
          -  What is the impact of Myofascial pain syndrome seen in breast cancer associted lymhedema
             patients on upper extremity function and quality of life?
  Mastectomy, breast conserving surgery, axillary lymph node dissection, sentinel lymph node
        biopsy and radiotherapy treatments have significant results in skin, muscle and fascia
        tissues in the upper extremity.
  
        Upper extremity function is defined by the International Consortium for Measures of Health
        Outcomes (ICHOM) as one of the most important health measures in breast cancer patients.
        Long-term upper extremity dysfunction has serious effects on patients' quality of life.
  
        Lymphedema, severe pain, decrease in shoulder joint range of motion, myofascial pain
        syndrome, myofascial adhesions are the leading causes affecting upper extremity function in
        patients with breast cancer.
  
        Myofascial pain syndrome (MPS) is commonly seen in patients with musculoskeletal problems and
        originates from muscle and surrounding tissues. It is characterized by localized or referred
        pain in a limited area and trigger points in the affected muscles. The incidence of
        myofascial pain syndrome secondary to breast cancer surgery is unknown. There is not yet a
        study in the literature that reveals the relationship between the stage of lymphedema and the
        frequency of accompanying myofascial pain syndrome in the breast cancer patients.
  
        This study is designed as cross sectional- single centered and single blind. It is planned to
        include 110 breast cancer patients who had undergone the treatments as mastectomy, breast
        conserving surgery, lymph node dissection, sentinele lymph node biopsy or radiotherapy aged
        between 18-75 years-old, visiting our oncological rehabilitation outpatient clinic August
        2023 through May 2024.
  
        Patients will be divided into 2 groups according to the stage of lymphedema. It is known that
        pathophysiological changes develop even if there is no visible lymphedema in patients
        undergoing surgery and/or radiotherapy for breast cancer. There is a lifetime risk of
        developing lymphedema, so these patients are considered as Stage 0 (latent) . The patients
        with less than 3 cm difference between the circumference measurements of upper extremities
        will be included in the 1st group.( Stage 0) (n=55) Patients who have more than 3 cm
        difference between the circumference measurements of upper extremities and those with Stage
        1,2 or 3 lymphedema will be included in the second group (n=55) The frequency of myofascial
        pain syndrome will be determined by the diagnostic criterias in both groups. The trigger
        points in trapezius, infraspinatus, serratus anterior, latissimus dorsi and pectoralis major
        muscles will be examined and the pain-pressure threshold values will be measured with an
        algometer.
  
        For the evaluation of upper extremity function and quality of life following measurement
        tools will be utilized in both groups: Hand-grip test with a dynamometer, goniometric
        measurement of range of motion (ROM) of shoulder joint, VAS numerical scales, LYMQOL and DASH
        questionnaires.
  
        Data analysis will be performed by using the Statistical Package for the Social Sciences
        (SPSS, version 20.0, IBM Corp., Armonk, NY, USA).
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: The Evaluation of Trigger Points
  time frame: 3 days
  description: Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.
  measure: Clinical Diagnostic Criteria of Myofascial Pain Syndrome
  time frame: 3 days
  description: Major criteria: 1. The patient's complaint of regional pain 2. Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point 3. Presence of palpable taut band 4. Presence of palpable and tender points along the length of the taut band 5. Restriction of ROM in the area of the affected muscle Minor criteria: 1. Pain/sensory change with pressure palpation of the trigger point 2. Local twitch response with palpation/injection of the trigger point in the taut band 3. Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis
  measure: Hand Grip Test
  time frame: 3 days
  description: The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.
  measure: Range of motion of shoulder joint
  time frame: 3 days
  description: Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.
  measure: VAS
  time frame: 3 days
  description: Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
  measure: Quick-DASH (The Disabilities of the Arm, Shoulder and Hand)
  time frame: 3 days
  description: The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.
  measure: LYMQOL-arm (Lymphedema Quality of Life -arm)
  time frame: 3 days
  description: Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  description: It is known that pathophysiological changes develop even if there is no visible lymphedema in patients undergoing surgery and/or radiotherapy for breast cancer. There is a lifetime risk of developing lymphedema, so these patients are considered as Stage 0 (latent). The patients with less than 3 cm difference between the circumference measurements of upper extremities will be included in the 1st group.( Stage 0) (n=55)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  description: Patients who have more than 3 cm difference between the circumference measurements of upper extremities and those with Stage 1,2 or 3 lymphedema will be included in the second group (n=55)
  intervention type: Diagnostic Test
  intervention name: Diagnostic Criteria of Myofascial Pain Syndrome
  description: Major criteria:
  The patient's complaint of regional pain
  Referred pain and sensory change in the specific area of the muscle by palpation of the trigger point
  Presence of palpable taut band
  Presence of palpable and tender points along the length of the taut band
  Restriction of ROM in the area of the affected muscle
  Minor criteria:
  Pain/sensory change with pressure palpation of the trigger point
  Local twitch response with palpation/injection of the trigger point in the taut band
  Reduction of pain by inactivation (injection or stretching of the muscle) of the trigger point 5 major and at least 1 minor criteria are required for clinical diagnosis
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  intervention type: Diagnostic Test
  intervention name: The Physical Examination of Trigger Points and Pain-Pressure Threshold Measurement With an Algometer
  description: Trigger points in trapezius, infraspinatus, latissimus dorsi, pectoralis major, serratus anterior muscles will be detected bilaterally by physical examination. Algometer (Wagner Force Dial FDK 20) will be used for pain pressure threshold measurement of detected trigger points. Then, the distribution of the trigger points, their frequency and threshold values according to the algometer will be compared between the individual affected-insured extremities and between the groups.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  intervention type: Diagnostic Test
  intervention name: Hand Grip Test
  description: The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 5 minutes. The test will be repeated for both upper extremities separately.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  intervention type: Diagnostic Test
  intervention name: VAS
  description: Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  intervention type: Diagnostic Test
  intervention name: Quick DASH
  description: The quick DASH questionnaire which has proven reliable and valid in breast cancer and lymphedema patients in Turkish population, will be used to evaluate the quality of life related to upper extremity function.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  intervention type: Diagnostic Test
  intervention name: Lymqol-Arm
  description: Lymphedema Quality of Life Scale-Arm Turkish form will be used. The lymphedema-specific quality of life scale was developed specifically for the upper extremity and its reliability and validity were proven in Turkish population.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  intervention type: Diagnostic Test
  intervention name: Range of Motion of Shoulde Joint
  description: Goniometric measurements will be made for both upper extremities, and the average of 3 consecutive measurements will be taken.
  arm group label: Group 1 (Patients with Stage 0 lymphedema)
  arm group label: Group 2 (Patients with Stage 1,2 or 3 lymphedema)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female Breast Cancer Patients
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yeliz Bahar Özdemir
  role: Principal Investigator
  last name: Özden Tömek, MD
  phone: Turkey: +905343284941
  email: ozden.tomek@gmail.com
  last name: Gökçenur Yalçın, MD
  phone: +905301413290
  email: gokce_cihaner@hotmail.com
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Myofascial Pain Syndromes
  mesh term: Fibromyalgia
  mesh term: Lymphedema
  mesh term: Breast Cancer Lymphedema
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: Undecided
  ipd description: Undecided