<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/NCT03295890</url>
  </required_header>
  <id_info>
    <org_study_id>USaoPauloGHGZ</org_study_id>
    <nct_id>NCT03295890</nct_id>
  </id_info>
  <brief_title>Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study</brief_title>
  <official_title>Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General 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>
      Self paring study, double blind placebo controlled with chronic tinnitus patients attended at&#xD;
      the Tinnitus Research Group HC- FMUSP, complaining of neck and/or cervical pain and with&#xD;
      myofascial trigger point in the head, neck and/or shoulder. They were submitted to a complete&#xD;
      otolaryngologist evaluation which included history, physical examination and myofascial&#xD;
      trigger point checkup. Patients also performed blood tests, tonal and vocal audiometry, and&#xD;
      psychoacoustic tinnitus measures. Self paring study, double blind placebo controlled. Each&#xD;
      patient will be subjected to the dry needling placebo, 4 sessions, 1 per week, with placebo&#xD;
      stretching, followed by washout period of two weeks, and 4 more dry needling therapeutic&#xD;
      sessions and active stretching. On the first day of the study will be conducted the following&#xD;
      evaluation: questionnaires THI and NDI, quantification of cervical pain and tinnitus through&#xD;
      the Visual analogue scale (VAS), search and confirmation of the presence of PGM and cervical&#xD;
      pain, psychoacoustic measures and somatic tests. This evaluation will be repeated at the end&#xD;
      of the four placebo sessions, at the beginning of therapeutic needling sessions and at the&#xD;
      end of the same.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first phase of the study will be the placebo needling, performed with a sham needle and&#xD;
      following the same procedures than the therapeutic treatment. Four placebo sessions will be&#xD;
      performed, 1 per week, with placebo stretching, followed by washout period of two weeks, and&#xD;
      4 more dry needling therapeutic sessions, also once a week and active stretching. The muscles&#xD;
      selected for dry needling were frontal, temporal, trapezius, masseter, sternocleidomastoid&#xD;
      (SCM), head splenius, scalene, medial pterygoid, lateral pterygoid, rhomboid.&#xD;
&#xD;
      Procedure technique Each patient was recommended to assume a relaxed posture suitable to&#xD;
      access the muscles being treated, instructed to expose the painful area, settled himself in&#xD;
      supine, prone, or side lying positions, at a stretcher or a chair, depending on the muscle to&#xD;
      be treated. The main therapist performed MTP target with a pen, hands antisepsis, gloves wear&#xD;
      and skin area cleaning with 70% isopropyl alcohol prior to needling. Along all procedure the&#xD;
      main therapist was able to view the patient's face and to receive regular treating feedback.&#xD;
      A sterile disposable filament needle was inserted directly perpendicular through the skin&#xD;
      using a guide tube that was then removed. Depth needle penetration with slow sidelong&#xD;
      direction in and outside displacements were performed through the muscle until reach MTP&#xD;
      spot. The patient's reaction indicated a &quot;DEQI&quot; (name given for the vague sensation of&#xD;
      needle-specific pain) or a &quot;twitch response&quot; (deflagration of a contractile muscle answer in&#xD;
      the moment that maximum muscle shortening fibers were broken). At this point needle was&#xD;
      leaved static in situ for 30-60 seconds. After the correct treatment needle was removed and&#xD;
      the muscle was active stretched.&#xD;
&#xD;
      Variables studied before and after therapeutic needling were:&#xD;
&#xD;
        1. Tinnitus annoying as measured by AVS.&#xD;
&#xD;
        2. Pain magnitude as measured by AVS.&#xD;
&#xD;
        3. Tinnitus impact on patient's quality of life through THI questionnaire validated for&#xD;
           Portuguese language.&#xD;
&#xD;
        4. Cervical pain impact on patient's quality of life through NDI questionnaire validated&#xD;
           for Portuguese language.&#xD;
&#xD;
        5. Tinnitus MML through psychoacoustic measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 29, 2016</start_date>
  <completion_date type="Anticipated">July 29, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Placebo Dry Needling</measure>
    <time_frame>4 weeks</time_frame>
    <description>Placebo Needling on trigger points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active Dry needling</measure>
    <time_frame>4 weeks</time_frame>
    <description>Therapeutic needling on trigger points</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Tinnitus</condition>
  <condition>Trigger Point Pain, Myofascial</condition>
  <condition>Somatosensory Disorders</condition>
  <arm_group>
    <arm_group_label>Sham Needling</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Intervention = Sham Needling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Needling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention = Active Needling</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dry Needing</intervention_name>
    <description>Dry Needling</description>
    <arm_group_label>Active Needling</arm_group_label>
    <arm_group_label>Sham Needling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With constant tinnitus, unilateral or bilateral, for more than 6 months,&#xD;
&#xD;
          -  Both sexes,&#xD;
&#xD;
          -  Over 18 years,&#xD;
&#xD;
          -  Presence of at least one PGM (active or latent),&#xD;
&#xD;
          -  Diagnosis of Myofascial pain syndrome, according to the criteria of Travell and&#xD;
             Simons.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With prior experience with the use of needles for therapeutic purposes,&#xD;
&#xD;
          -  With formal contraindication to dry needling, as chronic use of anticoagulants or&#xD;
             hematologic diseases,&#xD;
&#xD;
          -  Those who refuse the proposed therapies, for example, phobia of needles,&#xD;
&#xD;
          -  In use of medications for pain able to interfere with the result of the study, such as&#xD;
             anti-inflammatory and or muscle relaxers, until 30 days before the initial assessment,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Bento, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeanne Oiticica, MD PhD</last_name>
    <phone>5511974361596</phone>
    <email>jeanne.ramalho@uol.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juliana Aguiar, MD</last_name>
    <phone>5511982921245</phone>
    <email>juliana.anauate@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeanne Oiticica, MD PhD</last_name>
      <phone>+551130880299</phone>
      <email>jeanneramalho@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Juliana Anauate, MD</last_name>
      <phone>+5511982921245</phone>
      <email>juliana.anauate@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>myofascial trigger point, tinnitus, dry needling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Tinnitus</mesh_term>
    <mesh_term>Somatosensory Disorders</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/NCT03295890
org study id: USaoPauloGHGZ
nct id: NCT03295890
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Self paring study, double blind placebo controlled with chronic tinnitus patients attended at
      the Tinnitus Research Group HC- FMUSP, complaining of neck and/or cervical pain and with
      myofascial trigger point in the head, neck and/or shoulder. They were submitted to a complete
      otolaryngologist evaluation which included history, physical examination and myofascial
      trigger point checkup. Patients also performed blood tests, tonal and vocal audiometry, and
      psychoacoustic tinnitus measures. Self paring study, double blind placebo controlled. Each
      patient will be subjected to the dry needling placebo, 4 sessions, 1 per week, with placebo
      stretching, followed by washout period of two weeks, and 4 more dry needling therapeutic
      sessions and active stretching. On the first day of the study will be conducted the following
      evaluation: questionnaires THI and NDI, quantification of cervical pain and tinnitus through
      the Visual analogue scale (VAS), search and confirmation of the presence of PGM and cervical
      pain, psychoacoustic measures and somatic tests. This evaluation will be repeated at the end
      of the four placebo sessions, at the beginning of therapeutic needling sessions and at the
      end of the same.
The first phase of the study will be the placebo needling, performed with a sham needle and
      following the same procedures than the therapeutic treatment. Four placebo sessions will be
      performed, 1 per week, with placebo stretching, followed by washout period of two weeks, and
      4 more dry needling therapeutic sessions, also once a week and active stretching. The muscles
      selected for dry needling were frontal, temporal, trapezius, masseter, sternocleidomastoid
      (SCM), head splenius, scalene, medial pterygoid, lateral pterygoid, rhomboid.

      Procedure technique Each patient was recommended to assume a relaxed posture suitable to
      access the muscles being treated, instructed to expose the painful area, settled himself in
      supine, prone, or side lying positions, at a stretcher or a chair, depending on the muscle to
      be treated. The main therapist performed MTP target with a pen, hands antisepsis, gloves wear
      and skin area cleaning with 70% isopropyl alcohol prior to needling. Along all procedure the
      main therapist was able to view the patient's face and to receive regular treating feedback.
      A sterile disposable filament needle was inserted directly perpendicular through the skin
      using a guide tube that was then removed. Depth needle penetration with slow sidelong
      direction in and outside displacements were performed through the muscle until reach MTP
      spot. The patient's reaction indicated a "DEQI" (name given for the vague sensation of
      needle-specific pain) or a "twitch response" (deflagration of a contractile muscle answer in
      the moment that maximum muscle shortening fibers were broken). At this point needle was
      leaved static in situ for 30-60 seconds. After the correct treatment needle was removed and
      the muscle was active stretched.

      Variables studied before and after therapeutic needling were:

        1. Tinnitus annoying as measured by AVS.

        2. Pain magnitude as measured by AVS.

        3. Tinnitus impact on patient's quality of life through THI questionnaire validated for
           Portuguese language.

        4. Cervical pain impact on patient's quality of life through NDI questionnaire validated
           for Portuguese language.

        5. Tinnitus MML through psychoacoustic measures.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Placebo Dry Needling
time frame: 4 weeks
description: Placebo Needling on trigger points
measure: Active Dry needling
time frame: 4 weeks
description: Therapeutic needling on trigger points
arm group label: Sham Needling
arm group type: Sham Comparator
description: Intervention = Sham Needling
arm group label: Active Needling
arm group type: Active Comparator
description: Intervention = Active Needling
intervention type: Procedure
intervention name: Dry Needing
description: Dry Needling
arm group label: Active Needling
arm group label: Sham Needling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ricardo Bento, MD PhD
role: Study Chair
affiliation: University of Sao Paulo
last name: Jeanne Oiticica, MD PhD
phone: 5511974361596
email: jeanne.ramalho@uol.com.br
last name: Juliana Aguiar, MD
phone: 5511982921245
email: juliana.anauate@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Sponsor
mesh term: Myofascial Pain Syndromes
mesh term: Tinnitus
mesh term: Somatosensory Disorders
sharing ipd: No