<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/NCT03300297</url>
  </required_header>
  <id_info>
    <org_study_id>BU 59-16</org_study_id>
    <nct_id>NCT03300297</nct_id>
  </id_info>
  <brief_title>Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder</brief_title>
  <official_title>Thrust Joint Manipulation to the Cervical Spine in Participants With a Primary Complaint of Temporomandibular Disorder (TMD): A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bradley University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nova Southeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bradley 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>
      Background: Temporomandibular disorder (TMD) is a common and costly problem that often leads&#xD;
      to chronic pain or dysfunction. There is moderate evidence to support physical therapy (PT)&#xD;
      interventions for individuals with TMD, yet they continue to be an underserved population. A&#xD;
      known relationship between TMD and the cervical spine exists with some evidence to support&#xD;
      the use of cervical interventions for TMD. Cervical spine thrust joint manipulation (TJM) is&#xD;
      an effective PT intervention that has been explored in a limited fashion for this population.&#xD;
&#xD;
      The purpose of this trial is to determine the immediate and short term (1 and 4 week) effects&#xD;
      of cervical TJM delivered by a physical therapist on pain, dysfunction, and perception of&#xD;
      change in persons with a primary complaint of TMD. The hypothesis is that all participants&#xD;
      will improve, and those in the cervical TJM group may have a greater degree of improvement.&#xD;
&#xD;
      Design: Participants will be randomized to one of two groups and all will receive physical&#xD;
      therapy. Forty-two willing participants, age 18-65 with TMD will complete the informed&#xD;
      consent process and screening for eligibility before being admitted. Participants will&#xD;
      receive a combined treatment of 1) behavioral education, a home exercise program, soft tissue&#xD;
      mobilization, and cervical spine TJM or 2) behavioral education, a home exercise program,&#xD;
      soft tissue mobilization, and sham manipulation. Participants will receive 4 treatments over&#xD;
      a period of 4 weeks.&#xD;
&#xD;
      Significance: The results of this clinical trial will provide evidence relative to the impact&#xD;
      of cervical spine TJM in the treatment of persons with TMD. Determining the effectiveness of&#xD;
      cervical spine TJM included with a combined treatment approach has clinical implication for&#xD;
      physical therapists and the patients they serve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: Research design following CONSORT guidelines. A blinded assessor will measure ROM&#xD;
      and PPT. Treating therapists will know group allocation and will receive training to&#xD;
      standardize assessments and treatments. Self-report and objective measurements will be taken&#xD;
      at baseline, immediately after treatment one, and at one and four week follow-ups.&#xD;
&#xD;
      Data Analysis (primary): Sample size estimations were completed using G-Power, a free online&#xD;
      downloadable program. An F-test family with ANOVA: Repeated measures, within-between&#xD;
      interaction protocol was selected. While it is optimal to power sample size estimations&#xD;
      around a functional outcome measure, the limited use of functional measures in this&#xD;
      population created an obstacle. The sample size estimation for this project was powered&#xD;
      around maximal mouth opening (MMO) as this most closely relates to function in the TMD&#xD;
      population. In order to account for 15% attrition, and maintain equal participants in each&#xD;
      arm of this study, the desired sample size is 42 participants.&#xD;
&#xD;
      A 2 x 4 mixed model analysis of variance (ANOVA) will be used with treatment group as the&#xD;
      between-subjects factor and time as the within-subjects factor. Separate ANOVAs will be&#xD;
      performed for dependent variables and the hypothesis of interest will be group by time&#xD;
      interaction for each ANOVA.&#xD;
&#xD;
      To determine if missing data points associated with dropouts were missing at random or&#xD;
      missing for systematic reasons, we will perform Little's Missing Completely at Random (MCAR)&#xD;
      Test. Intention to treat analysis will be performed by using expectation maximization whereby&#xD;
      missing data are computed using regression equations. Planned pair-wise comparisons will&#xD;
      examine the difference between baseline and follow-up periods using the Bonferroni equality&#xD;
      at an alpha level of 0.05.&#xD;
&#xD;
      Success will be dichotomized using the GROC scale. A cut-off score of +5 or higher on the&#xD;
      GROC will be used as a measure of success. Correlations between outcome measures (change&#xD;
      scores) and success will be analyzed using an independent t-test to determine if differences&#xD;
      between groups exist. Number needed to treat (NNT) will be calculated. Correlations among&#xD;
      dependent variables will be analyzed with Pearson/Spearman correlations. Examples include the&#xD;
      following: correlation between NDI and jaw functional measures, correlation among PPT at&#xD;
      various areas tested, and correlation between change in ROM and change in functional scores.&#xD;
      Data analysis will include 95% confidence intervals, and tables, charts, or other figures&#xD;
      will be utilized to display findings to enhance reader understanding. Effect size of primary&#xD;
      outcome measures including jaw ROM, JFLS, and TMD Disability Index will be calculated and&#xD;
      reported. If there is no significant difference between groups noted, a post-hoc power&#xD;
      analysis will be performed to determine the risk of Type II error.&#xD;
&#xD;
      Data Safety Plan/Subject Confidentiality: The PI will be responsible for educating all&#xD;
      clinicians, research assistants, and front office staff with RVPT, Bradley University, and&#xD;
      UNLV in confidentiality measures and data safety plans. This information will be part of the&#xD;
      live training and included in the Manuals of Standard Operating Procedures. The PI will also&#xD;
      periodically check in with each participating clinician, blinded assessor, and clinic office&#xD;
      staff member to review procedures and monitor recruitment and retention. This check will&#xD;
      occur once per month over the phone.&#xD;
&#xD;
      Standard Operating Procedures: Manual developed and used in training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Actual">December 6, 2018</completion_date>
  <primary_completion_date type="Actual">October 2, 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>
    <intervention_model_description>Participants will be randomly assigned to one of two intervention groups. Both will receive intervention and one group will receive cervical spine thrust joint manipulation while the other receives sham manipulation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will be blinded to group allocation. Blind assessors will be utilized to measure objective change in range of motion and pain pressure threshold.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Maximal Mouth Opening Range of Motion (mm)</measure>
    <time_frame>baseline, immediate, 1 week, 4 week</time_frame>
    <description>Jaw ROM, mouth opening</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pain with Numeric Pain Rating Scale</measure>
    <time_frame>baseline, immediate, 1 week, 4 week</time_frame>
    <description>NPRS, self-reported intensity of pain on 0-10 pain rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Function with Jaw Functional Limitation Scale</measure>
    <time_frame>baseline, 1 week, 4 week, 3 month, 6 month</time_frame>
    <description>JFLS, self report jaw functions rated 0-10 based on difficulty</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Fear with Tampa Scale of Kinesiophobia-TMD version</measure>
    <time_frame>baseline, 1 week, 4 week, 3 month, 6 month</time_frame>
    <description>self report scale to assess level of fear rating 12 items on a 1-4 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Rating of Change</measure>
    <time_frame>immediate, 1 week, 4 week</time_frame>
    <description>perception of overall change in a self report scale from -7 to +7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Function with Neck Disability Index</measure>
    <time_frame>baseline, 1 week, 4 week, 3 month, 6 month</time_frame>
    <description>10 item self report assessment of neck disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Function with TMD Disability Index</measure>
    <time_frame>baseline, 1 week, 4 week, 3 month, 6 month</time_frame>
    <description>10 item self report assessment of jaw dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Acceptable Symptom State</measure>
    <time_frame>4 week, 3 month, 6 month</time_frame>
    <description>Self report acceptable nature of current state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cervical Spine range of motion</measure>
    <time_frame>baseline, immediate, 1 week, 4 week</time_frame>
    <description>bubble inclinometer measurement of neck motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain pressure threshold</measure>
    <time_frame>baseline, immediate, 1 week, 4 week</time_frame>
    <description>digital algometer assessment of threshold</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ-2 Depression Screen</measure>
    <time_frame>baseline</time_frame>
    <description>2 question screen</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>Cervical Spine Thrust Joint Manipulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thrust Manipulation delivered to C0/1 and C2/3 on both the right and left side</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical Spine Sham Manipulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Manipulation delivered to C0/1 and C2/3 on both the right and left side</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical Spine Thrust Joint Manipulation</intervention_name>
    <description>High velocity, short amplitude thrust to the cervical spine</description>
    <arm_group_label>Cervical Spine Thrust Joint Manipulation</arm_group_label>
    <other_name>Grade V manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical Spine Sham Manipulation</intervention_name>
    <description>Manipulative hold position shy of end range without a thrust</description>
    <arm_group_label>Cervical Spine Sham Manipulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Program</intervention_name>
    <description>therapeutic exercise program and education</description>
    <arm_group_label>Cervical Spine Sham Manipulation</arm_group_label>
    <arm_group_label>Cervical Spine Thrust Joint Manipulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Suboccipital Release</intervention_name>
    <description>suboccipital soft tissue mobilization</description>
    <arm_group_label>Cervical Spine Sham Manipulation</arm_group_label>
    <arm_group_label>Cervical Spine Thrust Joint Manipulation</arm_group_label>
    <other_name>soft tissue mobilization</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 y/o&#xD;
&#xD;
          -  primary complaint of TMD pain&#xD;
&#xD;
          -  positive TMD screen&#xD;
&#xD;
          -  proficiency in English language&#xD;
&#xD;
          -  availability to attend 4 sessions&#xD;
&#xD;
          -  minimum level of disability (NPRS 2 or greater)&#xD;
&#xD;
          -  minimum level of disability (pain free mouth opening 50 mm or less).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  traumatic onset of symptoms&#xD;
&#xD;
          -  whiplash in the last 6 weeks&#xD;
&#xD;
          -  prior neck surgery&#xD;
&#xD;
          -  medical red flags suggestive on on-musculoskeletal origin of pain, systemic disease,&#xD;
             or neurological disease&#xD;
&#xD;
          -  contraindications to thrust joint manipulation (TJM),&#xD;
&#xD;
          -  previous TJM in the last 3 months&#xD;
&#xD;
          -  Worker's compensation&#xD;
&#xD;
          -  pending litigation regarding pain or injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Breanna C Reynolds, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bradley University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rock Valley Physical Therapy</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rock Valley Physical Therapy</name>
      <address>
        <city>Washington</city>
        <state>Illinois</state>
        <zip>61571</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.</citation>
    <PMID>22036893</PMID>
  </reference>
  <reference>
    <citation>Harrison AL, Thorp JN, Ritzline PD. A proposed diagnostic classification of patients with temporomandibular disorders: implications for physical therapists. J Orthop Sports Phys Ther. 2014 Mar;44(3):182-97. doi: 10.2519/jospt.2014.4847.</citation>
    <PMID>24579796</PMID>
  </reference>
  <reference>
    <citation>Kraus SL. Characteristics of 511 patients with temporomandibular disorders referred for physical therapy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):432-9. doi: 10.1016/j.oooo.2014.06.005. Epub 2014 Jul 2.</citation>
    <PMID>25240990</PMID>
  </reference>
  <reference>
    <citation>Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.</citation>
    <PMID>26144684</PMID>
  </reference>
  <reference>
    <citation>Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.</citation>
    <PMID>26294683</PMID>
  </reference>
  <reference>
    <citation>McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.</citation>
    <PMID>16649894</PMID>
  </reference>
  <reference>
    <citation>Paco M, Peleteiro B, Duarte J, Pinho T. The Effectiveness of Physiotherapy in the Management of Temporomandibular Disorders: A Systematic Review and Meta-analysis. J Oral Facial Pain Headache. 2016 Summer;30(3):210-20. doi: 10.11607/ofph.1661.</citation>
    <PMID>27472523</PMID>
  </reference>
  <reference>
    <citation>Silveira A, Gadotti IC, Armijo-Olivo S, Biasotto-Gonzalez DA, Magee D. Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int. 2015;2015:512792. doi: 10.1155/2015/512792. Epub 2015 Mar 26.</citation>
    <PMID>25883963</PMID>
  </reference>
  <reference>
    <citation>Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27.</citation>
    <PMID>20524969</PMID>
  </reference>
  <reference>
    <citation>La Touche R, Fernandez-de-las-Penas C, Fernandez-Carnero J, Escalante K, Angulo-Diaz-Parreno S, Paris-Alemany A, Cleland JA. The effects of manual therapy and exercise directed at the cervical spine on pain and pressure pain sensitivity in patients with myofascial temporomandibular disorders. J Oral Rehabil. 2009 Sep;36(9):644-52. doi: 10.1111/j.1365-2842.2009.01980.x. Epub 2009 Jul 14.</citation>
    <PMID>19627454</PMID>
  </reference>
  <reference>
    <citation>La Touche R, Paris-Alemany A, Mannheimer JS, Angulo-Diaz-Parreno S, Bishop MD, Lopez-Valverde-Centeno A, von Piekartz H, Fernandez-Carnero J. Does mobilization of the upper cervical spine affect pain sensitivity and autonomic nervous system function in patients with cervico-craniofacial pain?: A randomized-controlled trial. Clin J Pain. 2013 Mar;29(3):205-15. doi: 10.1097/AJP.0b013e318250f3cd.</citation>
    <PMID>22874091</PMID>
  </reference>
  <reference>
    <citation>Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.</citation>
    <PMID>21965492</PMID>
  </reference>
  <reference>
    <citation>Kraus S. Temporomandibular disorders, head and orofacial pain: cervical spine considerations. Dent Clin North Am. 2007 Jan;51(1):161-93, vii. doi: 10.1016/j.cden.2006.10.001.</citation>
    <PMID>17185065</PMID>
  </reference>
  <reference>
    <citation>Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.</citation>
    <PMID>16813476</PMID>
  </reference>
  <reference>
    <citation>Calixtre LB, Moreira RF, Franchini GH, Alburquerque-Sendin F, Oliveira AB. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil. 2015 Nov;42(11):847-61. doi: 10.1111/joor.12321. Epub 2015 Jun 7.</citation>
    <PMID>26059857</PMID>
  </reference>
  <reference>
    <citation>Mansilla-Ferragut P, Fernandez-de-Las Penas C, Alburquerque-Sendin F, Cleland JA, Bosca-Gandia JJ. Immediate effects of atlanto-occipital joint manipulation on active mouth opening and pressure pain sensitivity in women with mechanical neck pain. J Manipulative Physiol Ther. 2009 Feb;32(2):101-6. doi: 10.1016/j.jmpt.2008.12.003.</citation>
    <PMID>19243721</PMID>
  </reference>
  <reference>
    <citation>Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.</citation>
    <PMID>20436241</PMID>
  </reference>
  <reference>
    <citation>Mulet M, Decker KL, Look JO, Lenton PA, Schiffman EL. A randomized clinical trial assessing the efficacy of adding 6 x 6 exercises to self-care for the treatment of masticatory myofascial pain. J Orofac Pain. 2007 Fall;21(4):318-28.</citation>
    <PMID>18018993</PMID>
  </reference>
  <reference>
    <citation>Armijo-Olivo S, Magee D. Cervical musculoskeletal impairments and temporomandibular disorders. J Oral Maxillofac Res. 2013 Jan 1;3(4):e4. doi: 10.5037/jomr.2012.3404. eCollection 2013.</citation>
    <PMID>24422022</PMID>
  </reference>
  <reference>
    <citation>La Touche R, Fernandez-de-Las-Penas C, Fernandez-Carnero J, Diaz-Parreno S, Paris-Alemany A, Arendt-Nielsen L. Bilateral mechanical-pain sensitivity over the trigeminal region in patients with chronic mechanical neck pain. J Pain. 2010 Mar;11(3):256-63. doi: 10.1016/j.jpain.2009.07.003. Epub 2009 Nov 27.</citation>
    <PMID>19945351</PMID>
  </reference>
  <reference>
    <citation>Calixtre LB, Gruninger BL, Haik MN, Alburquerque-Sendin F, Oliveira AB. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test. J Appl Oral Sci. 2016 May-Jun;24(3):188-97. doi: 10.1590/1678-775720150240.</citation>
    <PMID>27383698</PMID>
  </reference>
  <reference>
    <citation>Cuccia AM, Caradonna C, Annunziata V, Caradonna D. Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: a randomized controlled trial. J Bodyw Mov Ther. 2010 Apr;14(2):179-84. doi: 10.1016/j.jbmt.2009.08.002. Epub 2009 Sep 20.</citation>
    <PMID>20226365</PMID>
  </reference>
  <reference>
    <citation>Visscher CM, Ohrbach R, van Wijk AJ, Wilkosz M, Naeije M. The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD). Pain. 2010 Sep;150(3):492-500. doi: 10.1016/j.pain.2010.06.002. Epub 2010 Jul 3.</citation>
    <PMID>20598804</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bradley University</investigator_affiliation>
    <investigator_full_name>Breanna Reynolds</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Temporomandibular joint</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Cervical spine thrust joint manipulation</keyword>
  <keyword>therapy, exercise</keyword>
  <keyword>Temporomandibular Disorders</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>
  </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/NCT03300297
org study id: BU 59-16
nct id: NCT03300297
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Temporomandibular disorder (TMD) is a common and costly problem that often leads
      to chronic pain or dysfunction. There is moderate evidence to support physical therapy (PT)
      interventions for individuals with TMD, yet they continue to be an underserved population. A
      known relationship between TMD and the cervical spine exists with some evidence to support
      the use of cervical interventions for TMD. Cervical spine thrust joint manipulation (TJM) is
      an effective PT intervention that has been explored in a limited fashion for this population.

      The purpose of this trial is to determine the immediate and short term (1 and 4 week) effects
      of cervical TJM delivered by a physical therapist on pain, dysfunction, and perception of
      change in persons with a primary complaint of TMD. The hypothesis is that all participants
      will improve, and those in the cervical TJM group may have a greater degree of improvement.

      Design: Participants will be randomized to one of two groups and all will receive physical
      therapy. Forty-two willing participants, age 18-65 with TMD will complete the informed
      consent process and screening for eligibility before being admitted. Participants will
      receive a combined treatment of 1) behavioral education, a home exercise program, soft tissue
      mobilization, and cervical spine TJM or 2) behavioral education, a home exercise program,
      soft tissue mobilization, and sham manipulation. Participants will receive 4 treatments over
      a period of 4 weeks.

      Significance: The results of this clinical trial will provide evidence relative to the impact
      of cervical spine TJM in the treatment of persons with TMD. Determining the effectiveness of
      cervical spine TJM included with a combined treatment approach has clinical implication for
      physical therapists and the patients they serve.
Methods: Research design following CONSORT guidelines. A blinded assessor will measure ROM
      and PPT. Treating therapists will know group allocation and will receive training to
      standardize assessments and treatments. Self-report and objective measurements will be taken
      at baseline, immediately after treatment one, and at one and four week follow-ups.

      Data Analysis (primary): Sample size estimations were completed using G-Power, a free online
      downloadable program. An F-test family with ANOVA: Repeated measures, within-between
      interaction protocol was selected. While it is optimal to power sample size estimations
      around a functional outcome measure, the limited use of functional measures in this
      population created an obstacle. The sample size estimation for this project was powered
      around maximal mouth opening (MMO) as this most closely relates to function in the TMD
      population. In order to account for 15% attrition, and maintain equal participants in each
      arm of this study, the desired sample size is 42 participants.

      A 2 x 4 mixed model analysis of variance (ANOVA) will be used with treatment group as the
      between-subjects factor and time as the within-subjects factor. Separate ANOVAs will be
      performed for dependent variables and the hypothesis of interest will be group by time
      interaction for each ANOVA.

      To determine if missing data points associated with dropouts were missing at random or
      missing for systematic reasons, we will perform Little's Missing Completely at Random (MCAR)
      Test. Intention to treat analysis will be performed by using expectation maximization whereby
      missing data are computed using regression equations. Planned pair-wise comparisons will
      examine the difference between baseline and follow-up periods using the Bonferroni equality
      at an alpha level of 0.05.

      Success will be dichotomized using the GROC scale. A cut-off score of +5 or higher on the
      GROC will be used as a measure of success. Correlations between outcome measures (change
      scores) and success will be analyzed using an independent t-test to determine if differences
      between groups exist. Number needed to treat (NNT) will be calculated. Correlations among
      dependent variables will be analyzed with Pearson/Spearman correlations. Examples include the
      following: correlation between NDI and jaw functional measures, correlation among PPT at
      various areas tested, and correlation between change in ROM and change in functional scores.
      Data analysis will include 95% confidence intervals, and tables, charts, or other figures
      will be utilized to display findings to enhance reader understanding. Effect size of primary
      outcome measures including jaw ROM, JFLS, and TMD Disability Index will be calculated and
      reported. If there is no significant difference between groups noted, a post-hoc power
      analysis will be performed to determine the risk of Type II error.

      Data Safety Plan/Subject Confidentiality: The PI will be responsible for educating all
      clinicians, research assistants, and front office staff with RVPT, Bradley University, and
      UNLV in confidentiality measures and data safety plans. This information will be part of the
      live training and included in the Manuals of Standard Operating Procedures. The PI will also
      periodically check in with each participating clinician, blinded assessor, and clinic office
      staff member to review procedures and monitor recruitment and retention. This check will
      occur once per month over the phone.

      Standard Operating Procedures: Manual developed and used in training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of two intervention groups. Both will receive intervention and one group will receive cervical spine thrust joint manipulation while the other receives sham manipulation.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will be blinded to group allocation. Blind assessors will be utilized to measure objective change in range of motion and pain pressure threshold.
measure: Change in Maximal Mouth Opening Range of Motion (mm)
time frame: baseline, immediate, 1 week, 4 week
description: Jaw ROM, mouth opening
measure: Change in Pain with Numeric Pain Rating Scale
time frame: baseline, immediate, 1 week, 4 week
description: NPRS, self-reported intensity of pain on 0-10 pain rating scale
measure: Change in Function with Jaw Functional Limitation Scale
time frame: baseline, 1 week, 4 week, 3 month, 6 month
description: JFLS, self report jaw functions rated 0-10 based on difficulty
measure: Change in Fear with Tampa Scale of Kinesiophobia-TMD version
time frame: baseline, 1 week, 4 week, 3 month, 6 month
description: self report scale to assess level of fear rating 12 items on a 1-4 scale
measure: Global Rating of Change
time frame: immediate, 1 week, 4 week
description: perception of overall change in a self report scale from -7 to +7
measure: Change in Function with Neck Disability Index
time frame: baseline, 1 week, 4 week, 3 month, 6 month
description: 10 item self report assessment of neck disability
measure: Change in Function with TMD Disability Index
time frame: baseline, 1 week, 4 week, 3 month, 6 month
description: 10 item self report assessment of jaw dysfunction
measure: Patient Acceptable Symptom State
time frame: 4 week, 3 month, 6 month
description: Self report acceptable nature of current state
measure: Change in Cervical Spine range of motion
time frame: baseline, immediate, 1 week, 4 week
description: bubble inclinometer measurement of neck motion
measure: Change in Pain pressure threshold
time frame: baseline, immediate, 1 week, 4 week
description: digital algometer assessment of threshold
measure: PHQ-2 Depression Screen
time frame: baseline
description: 2 question screen
arm group label: Cervical Spine Thrust Joint Manipulation
arm group type: Active Comparator
description: Thrust Manipulation delivered to C0/1 and C2/3 on both the right and left side
arm group label: Cervical Spine Sham Manipulation
arm group type: Sham Comparator
description: Sham Manipulation delivered to C0/1 and C2/3 on both the right and left side
intervention type: Other
intervention name: Cervical Spine Thrust Joint Manipulation
description: High velocity, short amplitude thrust to the cervical spine
arm group label: Cervical Spine Thrust Joint Manipulation
other name: Grade V manipulation
intervention type: Other
intervention name: Cervical Spine Sham Manipulation
description: Manipulative hold position shy of end range without a thrust
arm group label: Cervical Spine Sham Manipulation
intervention type: Other
intervention name: Home Program
description: therapeutic exercise program and education
arm group label: Cervical Spine Sham Manipulation
arm group label: Cervical Spine Thrust Joint Manipulation
intervention type: Other
intervention name: Suboccipital Release
description: suboccipital soft tissue mobilization
arm group label: Cervical Spine Sham Manipulation
arm group label: Cervical Spine Thrust Joint Manipulation
other name: soft tissue mobilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Breanna C Reynolds, DPT
role: Principal Investigator
affiliation: Bradley University
facility: 
facility: 
country: United States
citation: Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
PMID: 22036893
citation: Harrison AL, Thorp JN, Ritzline PD. A proposed diagnostic classification of patients with temporomandibular disorders: implications for physical therapists. J Orthop Sports Phys Ther. 2014 Mar;44(3):182-97. doi: 10.2519/jospt.2014.4847.
PMID: 24579796
citation: Kraus SL. Characteristics of 511 patients with temporomandibular disorders referred for physical therapy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):432-9. doi: 10.1016/j.oooo.2014.06.005. Epub 2014 Jul 2.
PMID: 25240990
citation: Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
PMID: 26144684
citation: Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
PMID: 26294683
citation: McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
PMID: 16649894
citation: Paco M, Peleteiro B, Duarte J, Pinho T. The Effectiveness of Physiotherapy in the Management of Temporomandibular Disorders: A Systematic Review and Meta-analysis. J Oral Facial Pain Headache. 2016 Summer;30(3):210-20. doi: 10.11607/ofph.1661.
PMID: 27472523
citation: Silveira A, Gadotti IC, Armijo-Olivo S, Biasotto-Gonzalez DA, Magee D. Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int. 2015;2015:512792. doi: 10.1155/2015/512792. Epub 2015 Mar 26.
PMID: 25883963
citation: Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27.
PMID: 20524969
citation: La Touche R, Fernandez-de-las-Penas C, Fernandez-Carnero J, Escalante K, Angulo-Diaz-Parreno S, Paris-Alemany A, Cleland JA. The effects of manual therapy and exercise directed at the cervical spine on pain and pressure pain sensitivity in patients with myofascial temporomandibular disorders. J Oral Rehabil. 2009 Sep;36(9):644-52. doi: 10.1111/j.1365-2842.2009.01980.x. Epub 2009 Jul 14.
PMID: 19627454
citation: La Touche R, Paris-Alemany A, Mannheimer JS, Angulo-Diaz-Parreno S, Bishop MD, Lopez-Valverde-Centeno A, von Piekartz H, Fernandez-Carnero J. Does mobilization of the upper cervical spine affect pain sensitivity and autonomic nervous system function in patients with cervico-craniofacial pain?: A randomized-controlled trial. Clin J Pain. 2013 Mar;29(3):205-15. doi: 10.1097/AJP.0b013e318250f3cd.
PMID: 22874091
citation: Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.
PMID: 21965492
citation: Kraus S. Temporomandibular disorders, head and orofacial pain: cervical spine considerations. Dent Clin North Am. 2007 Jan;51(1):161-93, vii. doi: 10.1016/j.cden.2006.10.001.
PMID: 17185065
citation: Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.
PMID: 16813476
citation: Calixtre LB, Moreira RF, Franchini GH, Alburquerque-Sendin F, Oliveira AB. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil. 2015 Nov;42(11):847-61. doi: 10.1111/joor.12321. Epub 2015 Jun 7.
PMID: 26059857
citation: Mansilla-Ferragut P, Fernandez-de-Las Penas C, Alburquerque-Sendin F, Cleland JA, Bosca-Gandia JJ. Immediate effects of atlanto-occipital joint manipulation on active mouth opening and pressure pain sensitivity in women with mechanical neck pain. J Manipulative Physiol Ther. 2009 Feb;32(2):101-6. doi: 10.1016/j.jmpt.2008.12.003.
PMID: 19243721
citation: Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.
PMID: 20436241
citation: Mulet M, Decker KL, Look JO, Lenton PA, Schiffman EL. A randomized clinical trial assessing the efficacy of adding 6 x 6 exercises to self-care for the treatment of masticatory myofascial pain. J Orofac Pain. 2007 Fall;21(4):318-28.
PMID: 18018993
citation: Armijo-Olivo S, Magee D. Cervical musculoskeletal impairments and temporomandibular disorders. J Oral Maxillofac Res. 2013 Jan 1;3(4):e4. doi: 10.5037/jomr.2012.3404. eCollection 2013.
PMID: 24422022
citation: La Touche R, Fernandez-de-Las-Penas C, Fernandez-Carnero J, Diaz-Parreno S, Paris-Alemany A, Arendt-Nielsen L. Bilateral mechanical-pain sensitivity over the trigeminal region in patients with chronic mechanical neck pain. J Pain. 2010 Mar;11(3):256-63. doi: 10.1016/j.jpain.2009.07.003. Epub 2009 Nov 27.
PMID: 19945351
citation: Calixtre LB, Gruninger BL, Haik MN, Alburquerque-Sendin F, Oliveira AB. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test. J Appl Oral Sci. 2016 May-Jun;24(3):188-97. doi: 10.1590/1678-775720150240.
PMID: 27383698
citation: Cuccia AM, Caradonna C, Annunziata V, Caradonna D. Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: a randomized controlled trial. J Bodyw Mov Ther. 2010 Apr;14(2):179-84. doi: 10.1016/j.jbmt.2009.08.002. Epub 2009 Sep 20.
PMID: 20226365
citation: Visscher CM, Ohrbach R, van Wijk AJ, Wilkosz M, Naeije M. The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD). Pain. 2010 Sep;150(3):492-500. doi: 10.1016/j.pain.2010.06.002. Epub 2010 Jul 3.
PMID: 20598804
responsible party type: Principal Investigator
investigator affiliation: Bradley University
investigator full name: Breanna Reynolds
investigator title: Assistant Professor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: No