<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/NCT03791528</url>
  </required_header>
  <id_info>
    <org_study_id>DorkuzEUTuran</org_study_id>
    <nct_id>NCT03791528</nct_id>
  </id_info>
  <brief_title>Is Kinesio Taping Treatment Effective in Sacroiliac Joint Dysfunction</brief_title>
  <official_title>Assessing the Effects of Kinesiological Taping On Function And Pain Scores in Patients With Sacroiliac Joint Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain is a common condition that affects 70% of people at least once. Sacroiliac&#xD;
      joint Dysfunction (SIJD) is a skipped health problem that is ignored in patients with low&#xD;
      back or hip pain. Fluoroscopy-guided SIJ injection showed that SIJD is a source of pain in&#xD;
      13-30% of patients with chronic low back pain. Inadequate function of SIJ leads to abnormal&#xD;
      gait pattern, pain during walking, increase in load on discs, long-term interdisciplinary&#xD;
      stability and causing to increase of the listhesis. The pain worsens with running, climbing&#xD;
      stairs or standing up from the sitting position. Pharmacological, non-pharmacological and if&#xD;
      required surgical treatment may be applied in the osteoarthritis treatment.&#xD;
      Non-pharmacological treatment includes patient education, exercise, massaging, SIJ,&#xD;
      manipulation-mobilization, chiropractic applications, physical therapy modalities, use of the&#xD;
      assistive device.&#xD;
&#xD;
      Kinesio Taping is a treatment that has not been studied much and can be applied in SIJD. When&#xD;
      investigators reviewed the literature, investigators found a study and a case report&#xD;
      investigating the activity of Kinesio taping in sacroiliac joint dysfunction. Although the&#xD;
      mechanism of Kinesio taping cannot be understood, it is claimed that it has four beneficial&#xD;
      effects: normalizes muscular function, improves blood and lymphatic circulation, reduces&#xD;
      pain, regulates possible disorders of joints. In studies showing the effectiveness of Kinesio&#xD;
      banding in the reduction of pain in health problems related to the waist area with the&#xD;
      highest number of publications, it was noted that the pain was reduced rapidly within three&#xD;
      days, decreased the need for analgesics within two weeks and increased function in daily&#xD;
      living activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized, controlled study. 52 participants will be included to study who&#xD;
      apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and&#xD;
      Rehabilitation Clinic with the complaint of hip and back pain, aged between 18-60 years.&#xD;
      Participants have diagnosed as Sacroiliac Joint Dysfunction according to The International&#xD;
      Association for the Study of Pain (IASP) diagnostic criteria. These participants will be&#xD;
      divided into two groups randomly (Treatment group n:26, control group n:26). Because the&#xD;
      therapeutic effect may be seen with unsealed banding in Kinesio taping and the placebo effect&#xD;
      may not be evaluated, After the last evaluation, participants in both groups will be given&#xD;
      the necessary treatment and since there is no study on this subject in the literature, no&#xD;
      treatment was given to the control group due to the fact that the actual effect of banding&#xD;
      was desired. The treated group received Kinesio taping 3 times at 5-day intervals, one of the&#xD;
      fan-shaped cut bands, 2-3 inches above the SIJ, and the other below 2-3 inches below the SIJ,&#xD;
      and crossed each other by 90 degrees. Both groups were evaluated at baseline and on the 15th&#xD;
      day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry&#xD;
      Pain Inquiry Form. The kinesiological taping group was also evaluated with VAS and positive&#xD;
      SIJ pain provocation tests, 20 minutes after the first banding, to assess the acute effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">June 21, 2019</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>Randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS ) for sacroiliac pain</measure>
    <time_frame>Change from baseline pain score at 15 th day</time_frame>
    <description>visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Oswestry Pain Inquiry Form for pain and quality of life</measure>
    <time_frame>All patients will evaluated at baseline, twentieth minute after application and on the 15th day.</time_frame>
    <description>It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Sacroiliac Joint Dysfunction</condition>
  <arm_group>
    <arm_group_label>Kinesio-taping Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the sacroiliac joint (SIJ), and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees. evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Without Kinesio-taping treatment evaluated at baseline and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio-taping treatment group</intervention_name>
    <description>In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the SIJ, and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees. evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire.</description>
    <arm_group_label>Kinesio-taping Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients aged 18-60&#xD;
&#xD;
          2. Based on the diagnostic criteria proposed by the International Association for the&#xD;
             Study of Pain (IASP):&#xD;
&#xD;
             i.Pain in the SIE region (hip/groin or lower extremity) ii.The pain felt in SIS,&#xD;
             revitalized by specific provocation tests&#xD;
&#xD;
          3. Patients with sacroiliac joint dysfunction and validity-validity-tested provocation&#xD;
             tests, at least 3 of 6 tests are positive&#xD;
&#xD;
        1.Distraction 2.Compression 3.Gaenslen 4.POSH Test ( Thigh Thrust) 5.Sacral Push 6.FABER 4.&#xD;
        Patients excluded from the presence of sacroiliitis by previous examinations and&#xD;
        examinations 5. The signing of the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe cognitive dysfunction&#xD;
&#xD;
          2. The presence of a neurological deficit in the lower extremity&#xD;
&#xD;
          3. Presence of known central nervous system or peripheral nervous system disease&#xD;
&#xD;
          4. Presence of known rheumatic disease (rheumatoid arthritis, ankylosing spondylitis,&#xD;
             etc.)&#xD;
&#xD;
          5. Have undergone major surgery for lower back and waist&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. Spondylolisthesis&#xD;
&#xD;
          8. Built-in osteoporosis&#xD;
&#xD;
          9. The presence of malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Banu Dilek</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dokuz Eylul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dokuz Eylul University</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Banu Dilek</investigator_full_name>
    <investigator_title>Assoc Prof</investigator_title>
  </responsible_party>
  <keyword>Sacroiliac Joint Dysfunction</keyword>
  <keyword>Kinesio Taping Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03791528
org study id: DorkuzEUTuran
nct id: NCT03791528
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Low back pain is a common condition that affects 70% of people at least once. Sacroiliac
      joint Dysfunction (SIJD) is a skipped health problem that is ignored in patients with low
      back or hip pain. Fluoroscopy-guided SIJ injection showed that SIJD is a source of pain in
      13-30% of patients with chronic low back pain. Inadequate function of SIJ leads to abnormal
      gait pattern, pain during walking, increase in load on discs, long-term interdisciplinary
      stability and causing to increase of the listhesis. The pain worsens with running, climbing
      stairs or standing up from the sitting position. Pharmacological, non-pharmacological and if
      required surgical treatment may be applied in the osteoarthritis treatment.
      Non-pharmacological treatment includes patient education, exercise, massaging, SIJ,
      manipulation-mobilization, chiropractic applications, physical therapy modalities, use of the
      assistive device.

      Kinesio Taping is a treatment that has not been studied much and can be applied in SIJD. When
      investigators reviewed the literature, investigators found a study and a case report
      investigating the activity of Kinesio taping in sacroiliac joint dysfunction. Although the
      mechanism of Kinesio taping cannot be understood, it is claimed that it has four beneficial
      effects: normalizes muscular function, improves blood and lymphatic circulation, reduces
      pain, regulates possible disorders of joints. In studies showing the effectiveness of Kinesio
      banding in the reduction of pain in health problems related to the waist area with the
      highest number of publications, it was noted that the pain was reduced rapidly within three
      days, decreased the need for analgesics within two weeks and increased function in daily
      living activities.
The study is a randomized, controlled study. 52 participants will be included to study who
      apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and
      Rehabilitation Clinic with the complaint of hip and back pain, aged between 18-60 years.
      Participants have diagnosed as Sacroiliac Joint Dysfunction according to The International
      Association for the Study of Pain (IASP) diagnostic criteria. These participants will be
      divided into two groups randomly (Treatment group n:26, control group n:26). Because the
      therapeutic effect may be seen with unsealed banding in Kinesio taping and the placebo effect
      may not be evaluated, After the last evaluation, participants in both groups will be given
      the necessary treatment and since there is no study on this subject in the literature, no
      treatment was given to the control group due to the fact that the actual effect of banding
      was desired. The treated group received Kinesio taping 3 times at 5-day intervals, one of the
      fan-shaped cut bands, 2-3 inches above the SIJ, and the other below 2-3 inches below the SIJ,
      and crossed each other by 90 degrees. Both groups were evaluated at baseline and on the 15th
      day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry
      Pain Inquiry Form. The kinesiological taping group was also evaluated with VAS and positive
      SIJ pain provocation tests, 20 minutes after the first banding, to assess the acute effect.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled study
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Visual Analog Scale (VAS ) for sacroiliac pain
time frame: Change from baseline pain score at 15 th day
description: visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.
measure: Modified Oswestry Pain Inquiry Form for pain and quality of life
time frame: All patients will evaluated at baseline, twentieth minute after application and on the 15th day.
description: It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage.
arm group label: Kinesio-taping Treatment Group
arm group type: Active Comparator
description: In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the sacroiliac joint (SIJ), and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees. evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire
arm group label: Control Group
arm group type: No Intervention
description: Without Kinesio-taping treatment evaluated at baseline and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire
intervention type: Other
intervention name: Kinesio-taping treatment group
description: In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the SIJ, and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees. evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire.
arm group label: Kinesio-taping Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Banu Dilek
role: Principal Investigator
affiliation: Dokuz Eylul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Banu Dilek
investigator title: Assoc Prof
mesh term: Joint Diseases
sharing ipd: Undecided