<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/NCT03250351</url>
  </required_header>
  <id_info>
    <org_study_id>12/2009</org_study_id>
    <nct_id>NCT03250351</nct_id>
  </id_info>
  <brief_title>Nerve Mobilization Techniques After Breast Cancer Surgery</brief_title>
  <acronym>PT-ND-BC</acronym>
  <official_title>Effectiveness of Nerve Mobilization Techniques at Improving Upper Limb Morbidity Following Breast Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective: to determine nerve mobilization techniques effectiveness at improving shoulder&#xD;
      disability in the early breast cancer postsurgical period, and whether the effect was&#xD;
      maintained at 24-month follow up. Design: prospective randomized and single blind trial where&#xD;
      participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up&#xD;
      will be conducted through seven physical therapy assessments: one before surgery, the second&#xD;
      one after surgery, the third one post-physical therapy intervention, the fourth one after&#xD;
      three months, the fifth after six months and, the sixth one after twelve months, and the&#xD;
      seven one after 24 months. Participants: one hundred and forty women, who are undergoing a&#xD;
      unilateral breast cancer surgery with axillary lymph node dissection in the Breast Cancer&#xD;
      Unit from &quot;Príncipe de Asturias&quot; Hospital. Intervention: Early physical therapy to control&#xD;
      group and Early physical therapy plus nerve mobilization to intervention group during the&#xD;
      three following weeks from surgery. Hypothesis: nerve mobilization helps brachial plexus&#xD;
      sliding among its interface which improves shoulder disability the inner arm.&#xD;
&#xD;
      Key outcomes: pain, functional impairment, physical therapy, quality of life. Data analysis:&#xD;
      quantitative variables through t-student test and qualitative variable though Chi test&#xD;
      through by Statistical Package for the Social Sciences software.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After giving their written informed consent, the participants will be summoned to perform the&#xD;
      first assessment prior to surgery. Once participants will be discharged from hospital,&#xD;
      approximately 3-5 days following the surgery, will be summoned to perform the second&#xD;
      assessment. Those who will fulfil the selection criteria will be randomly allocated into two&#xD;
      groups by an independent physical therapist. The experimental group will receive Early&#xD;
      Physical Therapy plus neural mobilization and the control group will receive Early Physical&#xD;
      Therapy. The same physical therapist will carry out all interventions for both groups. The&#xD;
      physical therapist who will carry out the randomization process as well as the one who will&#xD;
      perform the interventions will be the only two study members aware of group allocation. A&#xD;
      third independent and blinded physical therapist will perform the assessments for all&#xD;
      participants. Both physical therapists have more than fifteen years' experience in the&#xD;
      treatment of breast cancer side effects. The ULNT1 will be perform to detect&#xD;
      mechanosenstiviy-induced pain at presurgical and postsurgical assessments. The test sequence&#xD;
      and the criteria will be followed to identify a positive test will reproduce from de study of&#xD;
      de la Rosa.&#xD;
&#xD;
      In both groups, those women who will develop axillary web syndrome symptoms will receive an&#xD;
      approach that aim at improving vascular tissue flexibility. If secondary lymphoedema will&#xD;
      diagnose then complex decongestive physiotherapy will carry out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">December 10, 2022</completion_date>
  <primary_completion_date type="Actual">November 10, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Two groups: Experimental group &amp; Control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>As masking techniques, the people responsible for randomization of intervention in each group, the evaluation of subjects and data collection, the analysis of data will be independent. Participants are also masked, since we think they are unable to distinguish between NDG and CG interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of shoulder disability</measure>
    <time_frame>7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline</time_frame>
    <description>It will be measured by SPADI spanish validated version.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of shoulder range of motion</measure>
    <time_frame>7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline 7th after 24 months after intervention.</time_frame>
    <description>It will be measured by an inclinometer under the universal instructions and validated of the goniometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of strenght</measure>
    <time_frame>7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline</time_frame>
    <description>It will be measured by a dynamometer under the universal instructions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of pain intensity</measure>
    <time_frame>7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline</time_frame>
    <description>To measure the intensity and get the information on the characteristics (type of feeling, duration, aggravating factors and mitigating, irritability, nocturnal behavior and activities with the UL ...) will be used a validated questionnaire shoulder Pain and Disability Index (SPADI). Contains a numerical scale to collect each answer. The possible answers are 0 to 10, with 0 being no distress and 10 present such difficulty that needs help. The result of the questionnaire is between 0 (no pain) and 80 (the most pain possible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of health related quality of life</measure>
    <time_frame>7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline</time_frame>
    <description>It will be measured by FACTB spanish validated version.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Neural mobilization group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M) plus neurodynamic techniques consisting of neural tissue longitudinal glide using the Upper Limb Neurodynamic Test 1 (ULNT1), the neurodynamic test sequence for the median nerve, described by Butler and adapted by de la Rosa. With participants in the supine position, the shoulder was abducted and externally rotated, the scapula depressed, the forearm supinated, and the wrist and fingers extended. Mobilization was applied by depressing the scapula, flexing the elbow, and elevating the scapula, extending the elbow, within a pain-free range. The mobilization was applied for 2 minutes. Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M). Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural mobilization group</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Neural mobilization group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Neural mobilization group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women treated for unilateral breast cancer with surgery, including axillary lymph node&#xD;
             dissection at the Department of Gynecology and Obstetrics of &quot;Príncipe de Asturias&quot;&#xD;
             Hospital&#xD;
&#xD;
          -  No contraindication to physical therapy&#xD;
&#xD;
          -  Informed consent read, understood, and freely signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral breast cancer&#xD;
&#xD;
          -  Systemic disease (metastases)&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Loco regional recurrence&#xD;
&#xD;
          -  Chemotherapy as a neoadjuvant treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María Torres-Lacomba, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alcalá</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>María Torres-Lacomba</name>
      <address>
        <city>Madrid</city>
        <zip>28024</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://fisioterapia-saludmujer.web.uah.es/</url>
    <description>Physiotherapy in women´s health research group</description>
  </link>
  <reference>
    <citation>Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.</citation>
    <PMID>20068255</PMID>
  </reference>
  <reference>
    <citation>de la Rosa-Diaz I, Torres-Lacomba M, Acosta-Ramirez P, Orive IG, Nee RJ, de la Villa-Polo P, Andres-Esteban EM, Sanchez-Sanchez B. Protective myoelectric activity at performing upper limb neurodynamic test 1 in breast cancer survivors. A cross-sectional observational study. Musculoskelet Sci Pract. 2018 Aug;36:68-80. doi: 10.1016/j.msksp.2018.05.003. Epub 2018 May 22.</citation>
    <PMID>29860136</PMID>
  </reference>
  <reference>
    <citation>Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.</citation>
    <PMID>35079831</PMID>
  </reference>
  <reference>
    <citation>Torres-Lacomba M, Sanchez-Sanchez B, Prieto-Gomez V, Pacheco-da-Costa S, Yuste-Sanchez MJ, Navarro-Brazalez B, Gutierrez-Ortega C. Spanish cultural adaptation and validation of the shoulder pain and disability index, and the oxford shoulder score after breast cancer surgery. Health Qual Life Outcomes. 2015 May 23;13:63. doi: 10.1186/s12955-015-0256-y.</citation>
    <PMID>26001890</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Maria Torres Lacomba</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT03250351
org study id: 12/2009
nct id: NCT03250351
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: to determine nerve mobilization techniques effectiveness at improving shoulder
      disability in the early breast cancer postsurgical period, and whether the effect was
      maintained at 24-month follow up. Design: prospective randomized and single blind trial where
      participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up
      will be conducted through seven physical therapy assessments: one before surgery, the second
      one after surgery, the third one post-physical therapy intervention, the fourth one after
      three months, the fifth after six months and, the sixth one after twelve months, and the
      seven one after 24 months. Participants: one hundred and forty women, who are undergoing a
      unilateral breast cancer surgery with axillary lymph node dissection in the Breast Cancer
      Unit from "Príncipe de Asturias" Hospital. Intervention: Early physical therapy to control
      group and Early physical therapy plus nerve mobilization to intervention group during the
      three following weeks from surgery. Hypothesis: nerve mobilization helps brachial plexus
      sliding among its interface which improves shoulder disability the inner arm.

      Key outcomes: pain, functional impairment, physical therapy, quality of life. Data analysis:
      quantitative variables through t-student test and qualitative variable though Chi test
      through by Statistical Package for the Social Sciences software.
After giving their written informed consent, the participants will be summoned to perform the
      first assessment prior to surgery. Once participants will be discharged from hospital,
      approximately 3-5 days following the surgery, will be summoned to perform the second
      assessment. Those who will fulfil the selection criteria will be randomly allocated into two
      groups by an independent physical therapist. The experimental group will receive Early
      Physical Therapy plus neural mobilization and the control group will receive Early Physical
      Therapy. The same physical therapist will carry out all interventions for both groups. The
      physical therapist who will carry out the randomization process as well as the one who will
      perform the interventions will be the only two study members aware of group allocation. A
      third independent and blinded physical therapist will perform the assessments for all
      participants. Both physical therapists have more than fifteen years' experience in the
      treatment of breast cancer side effects. The ULNT1 will be perform to detect
      mechanosenstiviy-induced pain at presurgical and postsurgical assessments. The test sequence
      and the criteria will be followed to identify a positive test will reproduce from de study of
      de la Rosa.

      In both groups, those women who will develop axillary web syndrome symptoms will receive an
      approach that aim at improving vascular tissue flexibility. If secondary lymphoedema will
      diagnose then complex decongestive physiotherapy will carry out.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups: Experimental group & Control group
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: As masking techniques, the people responsible for randomization of intervention in each group, the evaluation of subjects and data collection, the analysis of data will be independent. Participants are also masked, since we think they are unable to distinguish between NDG and CG interventions.
measure: Change of shoulder disability
time frame: 7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
description: It will be measured by SPADI spanish validated version.
measure: Change of shoulder range of motion
time frame: 7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline 7th after 24 months after intervention.
description: It will be measured by an inclinometer under the universal instructions and validated of the goniometry.
measure: Change of strenght
time frame: 7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
description: It will be measured by a dynamometer under the universal instructions.
measure: Change of pain intensity
time frame: 7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
description: To measure the intensity and get the information on the characteristics (type of feeling, duration, aggravating factors and mitigating, irritability, nocturnal behavior and activities with the UL ...) will be used a validated questionnaire shoulder Pain and Disability Index (SPADI). Contains a numerical scale to collect each answer. The possible answers are 0 to 10, with 0 being no distress and 10 present such difficulty that needs help. The result of the questionnaire is between 0 (no pain) and 80 (the most pain possible).
measure: Change of health related quality of life
time frame: 7 physical therapy assessments to evaluate change from surgery: At baseline, 7 days from baseline, 1 month, 3 months, 6 months, and 12 months from baseline
description: It will be measured by FACTB spanish validated version.
arm group label: Neural mobilization group
arm group type: Experimental
description: 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M) plus neurodynamic techniques consisting of neural tissue longitudinal glide using the Upper Limb Neurodynamic Test 1 (ULNT1), the neurodynamic test sequence for the median nerve, described by Butler and adapted by de la Rosa. With participants in the supine position, the shoulder was abducted and externally rotated, the scapula depressed, the forearm supinated, and the wrist and fingers extended. Mobilization was applied by depressing the scapula, flexing the elbow, and elevating the scapula, extending the elbow, within a pain-free range. The mobilization was applied for 2 minutes. Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.
arm group label: Control group
arm group type: Active Comparator
description: 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M). Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks.
intervention type: Other
intervention name: Neural mobilization group
description: See arm/group descriptions
arm group label: Neural mobilization group
intervention type: Other
intervention name: Control group
description: See arm/group descriptions
arm group label: Control group
arm group label: Neural mobilization group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: María Torres-Lacomba, PhD
role: Principal Investigator
affiliation: University of Alcalá
facility: 
country: Spain
url: https://fisioterapia-saludmujer.web.uah.es/
description: Physiotherapy in women´s health research group
citation: Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.
PMID: 20068255
citation: de la Rosa-Diaz I, Torres-Lacomba M, Acosta-Ramirez P, Orive IG, Nee RJ, de la Villa-Polo P, Andres-Esteban EM, Sanchez-Sanchez B. Protective myoelectric activity at performing upper limb neurodynamic test 1 in breast cancer survivors. A cross-sectional observational study. Musculoskelet Sci Pract. 2018 Aug;36:68-80. doi: 10.1016/j.msksp.2018.05.003. Epub 2018 May 22.
PMID: 29860136
citation: Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.
PMID: 35079831
citation: Torres-Lacomba M, Sanchez-Sanchez B, Prieto-Gomez V, Pacheco-da-Costa S, Yuste-Sanchez MJ, Navarro-Brazalez B, Gutierrez-Ortega C. Spanish cultural adaptation and validation of the shoulder pain and disability index, and the oxford shoulder score after breast cancer surgery. Health Qual Life Outcomes. 2015 May 23;13:63. doi: 10.1186/s12955-015-0256-y.
PMID: 26001890
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Maria Torres Lacomba
investigator title: Professor
mesh term: Breast Neoplasms
sharing ipd: No