<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/NCT01706172</url>
  </required_header>
  <id_info>
    <org_study_id>TMJS</org_study_id>
    <nct_id>NCT01706172</nct_id>
  </id_info>
  <brief_title>Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection</brief_title>
  <official_title>Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chisel Peak Medical Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>K. Dean Reeves, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chisel Peak Medical Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be&#xD;
      quite long lasting and debilitating. Dextrose injection with a small needle has been notably&#xD;
      helpful in preliminary studies in reducing pain and improving jaw function. This randomized&#xD;
      trial will compare dextrose injection with sterile water injection for temporomandibular(jaw)&#xD;
      dysfunction, also known as TMD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of&#xD;
      symptom diminishment, especially in the elderly. However studies out to 2-8 years show&#xD;
      residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been&#xD;
      utilized empirically for many years and a marked reduction in pain and luxation after&#xD;
      intra-articular and pericapsular dextrose injection has been reported in a recent RCT.&#xD;
      However, small study size and lack of a non injection control have prevented any definitive&#xD;
      conclusions as the additional efficacy of including dextrose in the injectate. The mechanism&#xD;
      of action of dextrose injection was originally thought to be via a brief stimulation of the&#xD;
      inflammatory cascade with resultant production of growth factors. However, non-inflammatory&#xD;
      dextrose effects on growth factor production have been demonstrated, and, more recently,&#xD;
      dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1&#xD;
      receptor on peptidergic nerves). This has the theoretical benefit of reducing pain,&#xD;
      regardless of the status and position of the intraarticular cartilage or degree of&#xD;
      degenerative change of the TMD. The primary goal of this study is to evaluate the ability of&#xD;
      dextrose injection versus saline injection to reduce pain and improve functional complaints&#xD;
      referable to the temporomandibular joint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain</measure>
    <time_frame>3 Months</time_frame>
    <description>TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.</measure>
    <time_frame>3 Months</time_frame>
    <description>TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.</measure>
    <time_frame>1 year</time_frame>
    <description>TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Temporomandibular Joint Disorders</condition>
  <arm_group>
    <arm_group_label>Dextrose 20 % Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sterile Water Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Injection of 20% dextrose/ 0.2% lidocaine</intervention_name>
    <description>Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.</description>
    <arm_group_label>Dextrose 20 % Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine</intervention_name>
    <description>Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine</description>
    <arm_group_label>Sterile Water Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        more than 3 month history of :&#xD;
&#xD;
          -  Facial Pain NRS rating &gt; 5/10&#xD;
&#xD;
          -  Jaw symptom rating &gt; 5/10&#xD;
&#xD;
          -  Jaw function issues seen on examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any potential acute dental issue&#xD;
&#xD;
          -  Rheumatic inflammatory disease&#xD;
&#xD;
          -  Chronic intake of NSAIDs or corticosteroids.&#xD;
&#xD;
          -  Pain in other body location worse than jaw pain&#xD;
&#xD;
          -  Pain 10/10 in other body location.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W. Francois Louw, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chisel Peak Medical Centre</name>
      <address>
        <city>Invermere</city>
        <state>British Columbia</state>
        <zip>V0A 1K0</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.</citation>
    <PMID>21757278</PMID>
  </reference>
  <reference>
    <citation>Dumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, Belanger M. Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. Pain Med. 2012 Aug;13(8):990-9. doi: 10.1111/j.1526-4637.2012.01422.x. Epub 2012 Jul 3.</citation>
    <PMID>22759069</PMID>
  </reference>
  <reference>
    <citation>Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.</citation>
    <PMID>22515800</PMID>
  </reference>
  <reference>
    <citation>Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.</citation>
    <PMID>21969284</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Dr. W Francois Louw</investigator_full_name>
    <investigator_title>Clinical Instructor and Physician</investigator_title>
  </responsible_party>
  <keyword>TMD</keyword>
  <keyword>temporomandibular</keyword>
  <keyword>dextrose</keyword>
  <keyword>prolotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706172
org study id: TMJS
nct id: NCT01706172
lead sponsor: 
collaborator: 
has dmc: Yes
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be
      quite long lasting and debilitating. Dextrose injection with a small needle has been notably
      helpful in preliminary studies in reducing pain and improving jaw function. This randomized
      trial will compare dextrose injection with sterile water injection for temporomandibular(jaw)
      dysfunction, also known as TMD.
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of
      symptom diminishment, especially in the elderly. However studies out to 2-8 years show
      residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been
      utilized empirically for many years and a marked reduction in pain and luxation after
      intra-articular and pericapsular dextrose injection has been reported in a recent RCT.
      However, small study size and lack of a non injection control have prevented any definitive
      conclusions as the additional efficacy of including dextrose in the injectate. The mechanism
      of action of dextrose injection was originally thought to be via a brief stimulation of the
      inflammatory cascade with resultant production of growth factors. However, non-inflammatory
      dextrose effects on growth factor production have been demonstrated, and, more recently,
      dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1
      receptor on peptidergic nerves). This has the theoretical benefit of reducing pain,
      regardless of the status and position of the intraarticular cartilage or degree of
      degenerative change of the TMD. The primary goal of this study is to evaluate the ability of
      dextrose injection versus saline injection to reduce pain and improve functional complaints
      referable to the temporomandibular joint.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
time frame: 3 Months
description: TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
measure: Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
time frame: 3 Months
description: TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises
measure: TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
time frame: 1 year
description: TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
arm group label: Dextrose 20 % Injection
arm group type: Active Comparator
description: Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
arm group label: Sterile Water Injection
arm group type: Active Comparator
description: Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
intervention type: Other
intervention name: Injection of 20% dextrose/ 0.2% lidocaine
description: Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
arm group label: Dextrose 20 % Injection
intervention type: Other
intervention name: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
description: Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine
arm group label: Sterile Water Injection
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: W. Francois Louw, Doctor
role: Principal Investigator
affiliation: University of British Columbia, Canada
facility: 
country: Canada
citation: Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
PMID: 21757278
citation: Dumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, Belanger M. Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. Pain Med. 2012 Aug;13(8):990-9. doi: 10.1111/j.1526-4637.2012.01422.x. Epub 2012 Jul 3.
PMID: 22759069
citation: Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.
PMID: 22515800
citation: Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.
PMID: 21969284
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Dr. W Francois Louw
investigator title: Clinical Instructor and Physician
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Lidocaine