<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/NCT03782220</url>
  </required_header>
  <id_info>
    <org_study_id>2018-12</org_study_id>
    <nct_id>NCT03782220</nct_id>
  </id_info>
  <brief_title>Effects of Kinesio Taping in Patients With Somatosensory Tinnitus</brief_title>
  <official_title>Effects of Kinesio Taping in Patients With Somatosensory Tinnitus: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hitit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hitit University</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>
      There is no specific treatment that can cure somatosensory tinnitus and usually conservative&#xD;
      physical therapy modalities are used in the literature. The aim of the study is to&#xD;
      investigate the effect of kinesio taping applied to sternocleidomastoid, upper trapezium and&#xD;
      levator scapulae muscles on the somatosensory tinnitus associated with neck complaints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was designed as a prospective, randomized controlled and double blind trial.&#xD;
&#xD;
      Patients complaining of tinnitus were firstly subjected to otologic and audiologic evaluation&#xD;
      by an otolaryngologist. Tinnitus characteristics, such as severity (Tinnitus handicap Index,&#xD;
      tinnitus Visual Analog Scale- tinnitus VAS) , type (pulsatile/non-pulsatile), localization&#xD;
      (unilateral/ bilateral) and the frequency (number of days with symptoms) were recorded.&#xD;
      Patients were excluded if they had objective tinnitus, subjective tinnitus with hearing loss&#xD;
      or Meniere's disease, vertigo, middle ear pathologies, intracranial pathologies, whiplash&#xD;
      injury, previous cervical spinal surgery, pregnancy, infection, malignancy and if they&#xD;
      received cervical physical rehabilitation program in the past 3 months.&#xD;
&#xD;
      Patients who diagnosed with somatosensory tinnitus and concomitant neck complaints&#xD;
      (cervical-VAS score &gt;2) at least 6 weeks were referred to physical medicine and&#xD;
      rehabilitation outpatient clinic. Before the treatment, participants' demographics data&#xD;
      including age, gender, Body-Mass Index (BMI) and cervical pain VAS score were recorded and&#xD;
      physical examinations (cervical joint range of motion (cervical-ROM), cervical manual muscle&#xD;
      testing (cervical-MMT) and myofascial trigger points for sternocleidomastoid, upper trapezium&#xD;
      and levator scapulae muscles) were performed by one investigator.&#xD;
&#xD;
      Banding application performed for both groups once a week for four weeks. Tinnitus handicap&#xD;
      index score, tinnitus VAS, ROM of the cervical joint, cervical MMT, cervical pain VAS, Neck&#xD;
      Disability index score and myofascial trigger points of sternocleidomastoid, upper trapezium,&#xD;
      levator scapula was evaluated in all subjects by the same investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">September 7, 2018</completion_date>
  <primary_completion_date type="Actual">April 18, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus handicap Index (THI)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The questionnaire comprises 25 items with a functional subscale (11 items), emotional subscale (9 items), and catastrophic subscale (5 items). Each question is rated as 0 (none), 2 (sometimes), or 4 (always). Total score range from 0 to 100, with higher scores indicating higher levels of perceived tinnitus handicap.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tinnitus severity (tinnitus-VAS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The loudness of tinnitus was graded with a10 cm of visual analog scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely loud tinnitus)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervical pain (cervical-VAS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pain intensity was measured with VAS which is used to measure musculoskeletal pain with very good reliability and validity (VAS, 0-10 cm; 0 means no pain, 10 means severe pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Disability index score (NDI)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The NDI is designed to assess self - reported neck functional status. The questionnaire comprises 10 items related to pain, activities of daily living, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation, each rated on a 6-point Likert scale with a final score range of 0 (no disability) to 50 (major disability). Higher scores represent greater disability</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Tinnitus, Subjective</condition>
  <arm_group>
    <arm_group_label>Kinesio taping group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kinesio taping group&#xD;
Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles.&#xD;
Once a week , for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shame taping group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Shame taping group&#xD;
Application of kinesio band to same muscles except for the defined method which is considered to be ineffective.&#xD;
Once a week , for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio tape</intervention_name>
    <description>The Kinesio taping ( Kinesio Tex Gold, 2in x103.3 ft) was applied to sternocleidomastoid, upper trapezium and levator scapulae muscles by the muscle inhibition technique ( from insertion to origin of a muscle) for experimental group.</description>
    <arm_group_label>Kinesio taping group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shame tape</intervention_name>
    <description>For the Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension and with the neck in neutral position was used.</description>
    <arm_group_label>Shame taping group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has somatosensory tinnitus&#xD;
&#xD;
          -  Subject has concomitant neck complaints (cervical-VAS score &gt;2) at least 6 weeks&#xD;
&#xD;
          -  Subject were referred to physical medicine and rehabilitation outpatient clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of objective tinnitus&#xD;
&#xD;
          -  History of subjective tinnitus with hearing loss&#xD;
&#xD;
          -  History of Meniere's disease&#xD;
&#xD;
          -  History of vertigo&#xD;
&#xD;
          -  Hiistory of middle ear pathologies&#xD;
&#xD;
          -  History of intracranial pathologies&#xD;
&#xD;
          -  History of whiplash injury&#xD;
&#xD;
          -  History of previous cervical spinal surgery&#xD;
&#xD;
          -  History of infection or malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of having received cervical physical rehabilitation program in the past 3&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tuğba Atan</name>
      <address>
        <city>Çorum</city>
        <zip>19100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Ralli M, Altissimi G, Turchetta R, Mazzei F, Salviati M, Cianfrone F, Orlando MP, Testugini V, Cianfrone G. Somatosensory Tinnitus: Correlation between Cranio-Cervico-Mandibular Disorder History and Somatic Modulation. Audiol Neurootol. 2016;21(6):372-382. doi: 10.1159/000452472. Epub 2017 Jan 19.</citation>
    <PMID>28099967</PMID>
  </results_reference>
  <results_reference>
    <citation>Vanneste S, Plazier M, Van de Heyning P, De Ridder D. Transcutaneous electrical nerve stimulation (TENS) of upper cervical nerve (C2) for the treatment of somatic tinnitus. Exp Brain Res. 2010 Jul;204(2):283-7. doi: 10.1007/s00221-010-2304-5. Epub 2010 May 28.</citation>
    <PMID>20505927</PMID>
  </results_reference>
  <results_reference>
    <citation>Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012 Dec;78(6):21-6. doi: 10.5935/1808-8694.20120028.</citation>
    <PMID>23306563</PMID>
  </results_reference>
  <results_reference>
    <citation>Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016 Dec;26:125-131. doi: 10.1016/j.math.2016.08.005. Epub 2016 Aug 26.</citation>
    <PMID>27592038</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hitit University</investigator_affiliation>
    <investigator_full_name>Tuğba Atan</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>somatosensory tinnitus</keyword>
  <keyword>neck pain</keyword>
  <keyword>kinesio taping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT03782220
org study id: 2018-12
nct id: NCT03782220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is no specific treatment that can cure somatosensory tinnitus and usually conservative
      physical therapy modalities are used in the literature. The aim of the study is to
      investigate the effect of kinesio taping applied to sternocleidomastoid, upper trapezium and
      levator scapulae muscles on the somatosensory tinnitus associated with neck complaints.
The study was designed as a prospective, randomized controlled and double blind trial.

      Patients complaining of tinnitus were firstly subjected to otologic and audiologic evaluation
      by an otolaryngologist. Tinnitus characteristics, such as severity (Tinnitus handicap Index,
      tinnitus Visual Analog Scale- tinnitus VAS) , type (pulsatile/non-pulsatile), localization
      (unilateral/ bilateral) and the frequency (number of days with symptoms) were recorded.
      Patients were excluded if they had objective tinnitus, subjective tinnitus with hearing loss
      or Meniere's disease, vertigo, middle ear pathologies, intracranial pathologies, whiplash
      injury, previous cervical spinal surgery, pregnancy, infection, malignancy and if they
      received cervical physical rehabilitation program in the past 3 months.

      Patients who diagnosed with somatosensory tinnitus and concomitant neck complaints
      (cervical-VAS score >2) at least 6 weeks were referred to physical medicine and
      rehabilitation outpatient clinic. Before the treatment, participants' demographics data
      including age, gender, Body-Mass Index (BMI) and cervical pain VAS score were recorded and
      physical examinations (cervical joint range of motion (cervical-ROM), cervical manual muscle
      testing (cervical-MMT) and myofascial trigger points for sternocleidomastoid, upper trapezium
      and levator scapulae muscles) were performed by one investigator.

      Banding application performed for both groups once a week for four weeks. Tinnitus handicap
      index score, tinnitus VAS, ROM of the cervical joint, cervical MMT, cervical pain VAS, Neck
      Disability index score and myofascial trigger points of sternocleidomastoid, upper trapezium,
      levator scapula was evaluated in all subjects by the same investigator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Tinnitus handicap Index (THI)
time frame: 4 weeks
description: The questionnaire comprises 25 items with a functional subscale (11 items), emotional subscale (9 items), and catastrophic subscale (5 items). Each question is rated as 0 (none), 2 (sometimes), or 4 (always). Total score range from 0 to 100, with higher scores indicating higher levels of perceived tinnitus handicap.
measure: Tinnitus severity (tinnitus-VAS)
time frame: 4 weeks
description: The loudness of tinnitus was graded with a10 cm of visual analog scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely loud tinnitus)
measure: Cervical pain (cervical-VAS)
time frame: 4 weeks
description: Pain intensity was measured with VAS which is used to measure musculoskeletal pain with very good reliability and validity (VAS, 0-10 cm; 0 means no pain, 10 means severe pain).
measure: Neck Disability index score (NDI)
time frame: 4 weeks
description: The NDI is designed to assess self - reported neck functional status. The questionnaire comprises 10 items related to pain, activities of daily living, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation, each rated on a 6-point Likert scale with a final score range of 0 (no disability) to 50 (major disability). Higher scores represent greater disability
arm group label: Kinesio taping group
arm group type: Experimental
description: Kinesio taping group
Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles.
Once a week , for 4 weeks
arm group label: Shame taping group
arm group type: Placebo Comparator
description: Shame taping group
Application of kinesio band to same muscles except for the defined method which is considered to be ineffective.
Once a week , for 4 weeks
intervention type: Other
intervention name: Kinesio tape
description: The Kinesio taping ( Kinesio Tex Gold, 2in x103.3 ft) was applied to sternocleidomastoid, upper trapezium and levator scapulae muscles by the muscle inhibition technique ( from insertion to origin of a muscle) for experimental group.
arm group label: Kinesio taping group
intervention type: Other
intervention name: Shame tape
description: For the Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension and with the neck in neutral position was used.
arm group label: Shame taping group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Ralli M, Altissimi G, Turchetta R, Mazzei F, Salviati M, Cianfrone F, Orlando MP, Testugini V, Cianfrone G. Somatosensory Tinnitus: Correlation between Cranio-Cervico-Mandibular Disorder History and Somatic Modulation. Audiol Neurootol. 2016;21(6):372-382. doi: 10.1159/000452472. Epub 2017 Jan 19.
PMID: 28099967
citation: Vanneste S, Plazier M, Van de Heyning P, De Ridder D. Transcutaneous electrical nerve stimulation (TENS) of upper cervical nerve (C2) for the treatment of somatic tinnitus. Exp Brain Res. 2010 Jul;204(2):283-7. doi: 10.1007/s00221-010-2304-5. Epub 2010 May 28.
PMID: 20505927
citation: Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012 Dec;78(6):21-6. doi: 10.5935/1808-8694.20120028.
PMID: 23306563
citation: Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016 Dec;26:125-131. doi: 10.1016/j.math.2016.08.005. Epub 2016 Aug 26.
PMID: 27592038
responsible party type: Principal Investigator
investigator affiliation: Hitit University
investigator full name: Tuğba Atan
investigator title: Assoc. Prof.
mesh term: Tinnitus