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/NCT06035341</url>
    </required_header>
    <id_info>
      <org_study_id>09.2023.675</org_study_id>
      <nct_id>NCT06035341</nct_id>
    </id_info>
    <brief_title>The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction</brief_title>
    <official_title>Is There a Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marmara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Marmara 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>
        The aim of this study is to evaluate the relationship between Temporomandibular Disorders&#xD;
        (TMD) and Sacroiliac Joint Disfunction (SIJD) and to determine the immediate effect of&#xD;
        single-session orofacial manual therapy on SIJD. Patients will be treated for 1 session. The&#xD;
        evaluation was planned to be done twice, at the beginning and end of the session.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to evaluate the relationship between TMD and SIJD and to determine&#xD;
        the immediate effect of single-session orofacial manual therapy on SIJD. Patients diagnosed&#xD;
        with both TMD and SIJD will be participants of the study. Patients will be treated for 1&#xD;
        session. Immediately after the treatment, participants will be asked to walk for 5 minutes,&#xD;
        after which a second assessment will be done. The evaluation was planned to be done twice, at&#xD;
        the beginning and end of the session. Pressure pain threshold, joint range of motion,&#xD;
        functionality, and sacroiliac joint disfunction will be evaluated by using digital algometer,&#xD;
        ruler, &quot;Oswestry Disability Index (ODI)&quot; and specific tests respectively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>There are one study group. A single session of orofacial manual therapy will be applied to all participants.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Threshold: Digital algometer</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles and 1 cm below the Posterior Superior Iliac Spine (PSIS). The measurement will be made at 10 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). This process will be repeated three times and the average value will be calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements will be also included in our study (three times) with the largest recorded range taken.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>First Test for Sacroiliac Joint Disfunction: Distraction Test</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The patient lies in a supine position. Direct posterolateral pressure is applied to the bilateral anterior superior iliac spines, thus stressing the anterior sacroiliac ligament. Pathology in the Sacroiliac (SI) joint is considered if pain occurs in the hip.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Second Test for Sacroiliac Joint Disfunction: Compression Test</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The patient lies on his side with the affected side on top, with the hip at 45° flexion and the knees at 90° flexion. The physician stands behind the patient and applies pressure to the pelvis over the iliac crest directly toward the contralateral iliac crest. This test can be applied in a supine or prone position. Pathology in the SI joint is considered if pain occurs in the hip.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Third Test for Sacroiliac Joint Disfunction: Thigh Thrust Test</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The patient lies in a supine position. The hip is brought to 90º flexion. Pressure is applied directly toward the examination table. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation is established with hip flexion and adduction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fourth Test for Sacroiliac Joint Disfunction: Gaenslen Test</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The patient lies in a supine position close to the edge of the bed. The patient draws his leg toward the abdomen so as to place the knee and hip in flexion. The outside leg (closest to the practitioner) is allowed to hang down from the examination table, while the SI joint is contracted by placing pressure on the inside (furthest from the practitioner) iliac crest and outside leg. Pain indicates pathology of the SI joint on the tested side.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fifth Test for Sacroiliac Joint Disfunction: Sacral Thrust Test</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The patient lies in a prone position. The practitioner places one hand on the apex of the sacrum while applying direct pressure with the other hand. Pathology in the SI joint is considered if pain occurs in the hip.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sixth Test for Sacroiliac Joint Disfunction: Faber (Patrick) Test</measure>
      <time_frame>Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.</time_frame>
      <description>The patient lies in a supine position, while the practitioner stands beside the patient and bends the patient's knee, bringing the heel to the opposite knee. With the other hand, the practitioner ensures that the contralateral anterior superior iliac spine remains in a neutral position. The physician applies mild pressure to the bent knee. Pressure is assumed to be applied to the bilateral SI ligaments and hip joints. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation occurs with flexion, adduction and external rotation of the hip.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index (ODI) for Functional Low Back Pain</measure>
      <time_frame>Change between baseline (immediately before intervention) and 1 week post intervention. The intervention is one hour.</time_frame>
      <description>Oswestry Disability Index (ODI) will be used to evaluate low back pain. ODI consists of 10 items on the degree of severity to which low back trouble has affected the ability to manage in everyday life. The 10 sections cover the pain and the daily function (including pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity, and traveling). Each item is rated on a 6-point scale (0-5); the higher score means the higher level of disability related to low back pain.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">23</enrollment>
    <condition>Temporomandibular Joint Disorders</condition>
    <condition>Temporomandibular Disorder</condition>
    <arm_group>
      <arm_group_label>Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will be received orofacial manual therapy as treatment. The number of participants is planned to be 23.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Orofacial Manual Therapy</intervention_name>
      <description>As orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned.</description>
      <arm_group_label>Treatment Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteered to participate,&#xD;
  &#xD;
            -  Aged between 18-60 years old,&#xD;
  &#xD;
            -  Having the diagnosis of Temporomandibular Disorders (TMB) and sacroiliac joint&#xD;
               disfunction (SIJD),&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a malignant condition, trauma and surgery of the cranial and cervical region,&#xD;
  &#xD;
            -  Not being cooperative,&#xD;
  &#xD;
            -  Regular use of analgesic and anti-inflammatory drugs,&#xD;
  &#xD;
            -  Having dentofacial anomalies,&#xD;
  &#xD;
            -  Having active inflammatory arthritis,&#xD;
  &#xD;
            -  Having metabolic diseases (Gout, osteoporosis, Cushing's disease and&#xD;
               hyper/hypo-parathyroidism),&#xD;
  &#xD;
            -  Having connective tissue, rheumatological (Systemic lupus erythematosus and&#xD;
               scleroderma) and hematological disorders (Anemia and leukemia),&#xD;
  &#xD;
            -  Having a diagnosed psychiatric illness,&#xD;
  &#xD;
            -  Receiving TMD-related physical therapy less than 6 months ago&#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>Tugba Kuru Colak, Asst. Prof</last_name>
      <role>Study Director</role>
      <affiliation>Marmara University Institute of Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sultan Igrek, MSc</last_name>
      <phone>+05372100654</phone>
      <email>sultanigrek@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sultan İğrek</name>
        <address>
          <city>Istanbul</city>
          <zip>34275</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <phone>05372100654</phone>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://jag.journalagent.com/kocaelitip/pdfs/KTD_10_2_27_32.pdf</url>
      <description>Investigation of the Relationship Between Temporomandibular Disorder and Postural Analysis</description>
    </link>
    <link>
      <url>https://www.semanticscholar.org/paper/Manual-therapy-for-temporomandibular-disorders%3A-A-Kalamir-Pollard/eff17b74aec032c4f05e66879a61cd158ddda70d</url>
      <description>Manual Therapy for Temporomandibular Disorders: A Review of the Literature.</description>
    </link>
    <link>
      <url>https://www.scielo.br/j/rdor/a/dV5P7vngMkggzjZqKrCvHsR/?lang=en</url>
      <description>Pressure Pain Threshold and Pain Perception in Temporomandibular Disorder Patients: Is There Any Correlation?</description>
    </link>
    <reference>
      <citation>Anastassaki Kohler A, Hugoson A, Magnusson T. Prevalence of symptoms indicative of temporomandibular disorders in adults: cross-sectional epidemiological investigations covering two decades. Acta Odontol Scand. 2012 May;70(3):213-23. doi: 10.3109/00016357.2011.634832. Epub 2011 Nov 30.</citation>
      <PMID>22126531</PMID>
    </reference>
    <reference>
      <citation>Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.</citation>
      <PMID>32123652</PMID>
    </reference>
    <reference>
      <citation>Gregory TM. Temporomandibular disorder associated with sacroiliac sprain. J Manipulative Physiol Ther. 1993 May;16(4):256-65.</citation>
      <PMID>8340721</PMID>
    </reference>
    <reference>
      <citation>Chinappi AS Jr, Getzoff H. Chiropractic/dental cotreatment of lumbosacral pain with temporomandibular joint involvement. J Manipulative Physiol Ther. 1996 Nov-Dec;19(9):607-12.</citation>
      <PMID>8976480</PMID>
    </reference>
    <reference>
      <citation>Fink M, Wahling K, Stiesch-Scholz M, Tschernitschek H. The functional relationship between the craniomandibular system, cervical spine, and the sacroiliac joint: a preliminary investigation. Cranio. 2003 Jul;21(3):202-8. doi: 10.1080/08869634.2003.11746252.</citation>
      <PMID>12889677</PMID>
    </reference>
    <reference>
      <citation>Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.</citation>
      <PMID>23768273</PMID>
    </reference>
    <reference>
      <citation>Kalamir A, Pollard H, Vitiello A, Bonello R. Intra-oral myofascial therapy for chronic myogenous temporomandibular disorders: a randomized, controlled pilot study. J Man Manip Ther. 2010 Sep;18(3):139-46. doi: 10.1179/106698110X12640740712374.</citation>
      <PMID>21886424</PMID>
    </reference>
    <reference>
      <citation>von Piekartz H, Ludtke K. Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study. Cranio. 2011 Jan;29(1):43-56. doi: 10.1179/crn.2011.008.</citation>
      <PMID>21370769</PMID>
    </reference>
    <reference>
      <citation>Walker N, Bohannon RW, Cameron D. Discriminant validity of temporomandibular joint range of motion measurements obtained with a ruler. J Orthop Sports Phys Ther. 2000 Aug;30(8):484-92. doi: 10.2519/jospt.2000.30.8.484.</citation>
      <PMID>10949505</PMID>
    </reference>
    <reference>
      <citation>Telli H, Telli S, Topal M. The Validity and Reliability of Provocation Tests in the Diagnosis of Sacroiliac Joint Dysfunction. Pain Physician. 2018 Jul;21(4):E367-E376.</citation>
      <PMID>30045603</PMID>
    </reference>
    <reference>
      <citation>Robinson HS, Brox JI, Robinson R, Bjelland E, Solem S, Telje T. The reliability of selected motion- and pain provocation tests for the sacroiliac joint. Man Ther. 2007 Feb;12(1):72-9. doi: 10.1016/j.math.2005.09.004. Epub 2006 Jul 12.</citation>
      <PMID>16843031</PMID>
    </reference>
    <reference>
      <citation>Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97. doi: 10.1016/s0004-9514(14)60125-2.</citation>
      <PMID>12775204</PMID>
    </reference>
    <reference>
      <citation>Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21.</citation>
      <PMID>18560194</PMID>
    </reference>
    <reference>
      <citation>Cattley P, Winyard J, Trevaskis J, Eaton S. Validity and reliability of clinical tests for the sacroiliac joint. A review of literature. Australas Chiropr Osteopathy. 2002 Nov;10(2):73-80.</citation>
      <PMID>17987177</PMID>
    </reference>
    <reference>
      <citation>Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.</citation>
      <PMID>16038856</PMID>
    </reference>
    <reference>
      <citation>Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.</citation>
      <PMID>6450426</PMID>
    </reference>
    <reference>
      <citation>Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776. Erratum In: Phys Ther. 2008 Jan;88(1):138-9.</citation>
      <PMID>11175676</PMID>
    </reference>
    <reference>
      <citation>Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.</citation>
      <PMID>15129077</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Temporomandibular Joint Disorders</keyword>
    <keyword>Temporomandibular Joint</keyword>
    <keyword>Sacroiliac Joint</keyword>
    <keyword>Orofacial Pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Temporomandibular Joint Disorders</mesh_term>
      <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
      <mesh_term>Joint Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.</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/NCT06035341
  org study id: 09.2023.675
  nct id: NCT06035341
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the relationship between Temporomandibular Disorders
        (TMD) and Sacroiliac Joint Disfunction (SIJD) and to determine the immediate effect of
        single-session orofacial manual therapy on SIJD. Patients will be treated for 1 session. The
        evaluation was planned to be done twice, at the beginning and end of the session.
  The aim of this study is to evaluate the relationship between TMD and SIJD and to determine
        the immediate effect of single-session orofacial manual therapy on SIJD. Patients diagnosed
        with both TMD and SIJD will be participants of the study. Patients will be treated for 1
        session. Immediately after the treatment, participants will be asked to walk for 5 minutes,
        after which a second assessment will be done. The evaluation was planned to be done twice, at
        the beginning and end of the session. Pressure pain threshold, joint range of motion,
        functionality, and sacroiliac joint disfunction will be evaluated by using digital algometer,
        ruler, "Oswestry Disability Index (ODI)" and specific tests respectively.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: There are one study group. A single session of orofacial manual therapy will be applied to all participants.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain Threshold: Digital algometer
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles and 1 cm below the Posterior Superior Iliac Spine (PSIS). The measurement will be made at 10 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). This process will be repeated three times and the average value will be calculated.
  measure: Range of Motion
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements will be also included in our study (three times) with the largest recorded range taken.
  measure: First Test for Sacroiliac Joint Disfunction: Distraction Test
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The patient lies in a supine position. Direct posterolateral pressure is applied to the bilateral anterior superior iliac spines, thus stressing the anterior sacroiliac ligament. Pathology in the Sacroiliac (SI) joint is considered if pain occurs in the hip.
  measure: Second Test for Sacroiliac Joint Disfunction: Compression Test
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The patient lies on his side with the affected side on top, with the hip at 45° flexion and the knees at 90° flexion. The physician stands behind the patient and applies pressure to the pelvis over the iliac crest directly toward the contralateral iliac crest. This test can be applied in a supine or prone position. Pathology in the SI joint is considered if pain occurs in the hip.
  measure: Third Test for Sacroiliac Joint Disfunction: Thigh Thrust Test
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The patient lies in a supine position. The hip is brought to 90º flexion. Pressure is applied directly toward the examination table. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation is established with hip flexion and adduction.
  measure: Fourth Test for Sacroiliac Joint Disfunction: Gaenslen Test
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The patient lies in a supine position close to the edge of the bed. The patient draws his leg toward the abdomen so as to place the knee and hip in flexion. The outside leg (closest to the practitioner) is allowed to hang down from the examination table, while the SI joint is contracted by placing pressure on the inside (furthest from the practitioner) iliac crest and outside leg. Pain indicates pathology of the SI joint on the tested side.
  measure: Fifth Test for Sacroiliac Joint Disfunction: Sacral Thrust Test
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The patient lies in a prone position. The practitioner places one hand on the apex of the sacrum while applying direct pressure with the other hand. Pathology in the SI joint is considered if pain occurs in the hip.
  measure: Sixth Test for Sacroiliac Joint Disfunction: Faber (Patrick) Test
  time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
  description: The patient lies in a supine position, while the practitioner stands beside the patient and bends the patient's knee, bringing the heel to the opposite knee. With the other hand, the practitioner ensures that the contralateral anterior superior iliac spine remains in a neutral position. The physician applies mild pressure to the bent knee. Pressure is assumed to be applied to the bilateral SI ligaments and hip joints. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation occurs with flexion, adduction and external rotation of the hip.
  measure: Oswestry Disability Index (ODI) for Functional Low Back Pain
  time frame: Change between baseline (immediately before intervention) and 1 week post intervention. The intervention is one hour.
  description: Oswestry Disability Index (ODI) will be used to evaluate low back pain. ODI consists of 10 items on the degree of severity to which low back trouble has affected the ability to manage in everyday life. The 10 sections cover the pain and the daily function (including pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity, and traveling). Each item is rated on a 6-point scale (0-5); the higher score means the higher level of disability related to low back pain.
  arm group label: Treatment Group
  arm group type: Experimental
  description: Participants in this group will be received orofacial manual therapy as treatment. The number of participants is planned to be 23.
  intervention type: Other
  intervention name: Orofacial Manual Therapy
  description: As orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned.
  arm group label: Treatment Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Tugba Kuru Colak, Asst. Prof
  role: Study Director
  affiliation: Marmara University Institute of Health Sciences
  last name: Sultan Igrek, MSc
  phone: +05372100654
  email: sultanigrek@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  url: https://jag.journalagent.com/kocaelitip/pdfs/KTD_10_2_27_32.pdf
  description: Investigation of the Relationship Between Temporomandibular Disorder and Postural Analysis
  url: https://www.semanticscholar.org/paper/Manual-therapy-for-temporomandibular-disorders%3A-A-Kalamir-Pollard/eff17b74aec032c4f05e66879a61cd158ddda70d
  description: Manual Therapy for Temporomandibular Disorders: A Review of the Literature.
  url: https://www.scielo.br/j/rdor/a/dV5P7vngMkggzjZqKrCvHsR/?lang=en
  description: Pressure Pain Threshold and Pain Perception in Temporomandibular Disorder Patients: Is There Any Correlation?
  citation: Anastassaki Kohler A, Hugoson A, Magnusson T. Prevalence of symptoms indicative of temporomandibular disorders in adults: cross-sectional epidemiological investigations covering two decades. Acta Odontol Scand. 2012 May;70(3):213-23. doi: 10.3109/00016357.2011.634832. Epub 2011 Nov 30.
  PMID: 22126531
  citation: Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
  PMID: 32123652
  citation: Gregory TM. Temporomandibular disorder associated with sacroiliac sprain. J Manipulative Physiol Ther. 1993 May;16(4):256-65.
  PMID: 8340721
  citation: Chinappi AS Jr, Getzoff H. Chiropractic/dental cotreatment of lumbosacral pain with temporomandibular joint involvement. J Manipulative Physiol Ther. 1996 Nov-Dec;19(9):607-12.
  PMID: 8976480
  citation: Fink M, Wahling K, Stiesch-Scholz M, Tschernitschek H. The functional relationship between the craniomandibular system, cervical spine, and the sacroiliac joint: a preliminary investigation. Cranio. 2003 Jul;21(3):202-8. doi: 10.1080/08869634.2003.11746252.
  PMID: 12889677
  citation: Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.
  PMID: 23768273
  citation: Kalamir A, Pollard H, Vitiello A, Bonello R. Intra-oral myofascial therapy for chronic myogenous temporomandibular disorders: a randomized, controlled pilot study. J Man Manip Ther. 2010 Sep;18(3):139-46. doi: 10.1179/106698110X12640740712374.
  PMID: 21886424
  citation: von Piekartz H, Ludtke K. Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study. Cranio. 2011 Jan;29(1):43-56. doi: 10.1179/crn.2011.008.
  PMID: 21370769
  citation: Walker N, Bohannon RW, Cameron D. Discriminant validity of temporomandibular joint range of motion measurements obtained with a ruler. J Orthop Sports Phys Ther. 2000 Aug;30(8):484-92. doi: 10.2519/jospt.2000.30.8.484.
  PMID: 10949505
  citation: Telli H, Telli S, Topal M. The Validity and Reliability of Provocation Tests in the Diagnosis of Sacroiliac Joint Dysfunction. Pain Physician. 2018 Jul;21(4):E367-E376.
  PMID: 30045603
  citation: Robinson HS, Brox JI, Robinson R, Bjelland E, Solem S, Telje T. The reliability of selected motion- and pain provocation tests for the sacroiliac joint. Man Ther. 2007 Feb;12(1):72-9. doi: 10.1016/j.math.2005.09.004. Epub 2006 Jul 12.
  PMID: 16843031
  citation: Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97. doi: 10.1016/s0004-9514(14)60125-2.
  PMID: 12775204
  citation: Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21.
  PMID: 18560194
  citation: Cattley P, Winyard J, Trevaskis J, Eaton S. Validity and reliability of clinical tests for the sacroiliac joint. A review of literature. Australas Chiropr Osteopathy. 2002 Nov;10(2):73-80.
  PMID: 17987177
  citation: Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.
  PMID: 16038856
  citation: Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
  PMID: 6450426
  citation: Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776. Erratum In: Phys Ther. 2008 Jan;88(1):138-9.
  PMID: 11175676
  citation: Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
  PMID: 15129077
  responsible party type: Sponsor
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Joint Diseases
  sharing ipd: No
  ipd description: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.