<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/NCT01676129</url>
  </required_header>
  <id_info>
    <org_study_id>101R104054-TMJ</org_study_id>
    <nct_id>NCT01676129</nct_id>
  </id_info>
  <brief_title>Nocipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation in Treating Pain From TMJ Disorder</brief_title>
  <official_title>Comparing the Effect of Typical Electrical Stimulation Therapy With Nocipoint Stimulation Therapy on TMD-Related Myofascial Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pain Cure Center, California</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the effect of nocipoint therapy on patients with&#xD;
      temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical&#xD;
      stimulation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of temporomandibular disorders (TMD) is about 20% to 60% of dental patients.&#xD;
      Most patients suffer from myofascial pain (MFP) subtype of TMD. Analgesics, local muscle&#xD;
      injection or oral appliance are often used to treat TMD-related MFP. Patients are also&#xD;
      referred to physical therapists frequently. Many physical therapy (PT) modalities and&#xD;
      techniques are applied to these patients, including non-invasive transcutaneous electrical&#xD;
      nerve stimulation (TENS) using TENS devices. However, the exact application of TENS devices,&#xD;
      including the location of the stimulation, duration and intensity of stimulation, is largely&#xD;
      decided by physical therapists. Nocipoint Therapy, a unique combination of precise location,&#xD;
      duration and intensity of TENS has been found to substantially relieve general myofascial&#xD;
      pain and recover the muscle function with lasting effect.&#xD;
&#xD;
      In preliminary observations of clinical applications, Nocipoint Therapy has been found to&#xD;
      rapidly and substantially relieve TMD-related MFP within 2-3 sessions of the treatment.&#xD;
&#xD;
      This clinical study compares the effect of Nocipoint Therapy on TMD with that of standard&#xD;
      Physical therapy (PT). TENS will be used in the control group both as a part of the standard&#xD;
      of care (i.e., PT) and as placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) for pain</measure>
    <time_frame>Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session</time_frame>
    <description>VAS is measured before each treatment session and at the follow-up:&#xD;
VAS - overall&#xD;
VAS - most painful&#xD;
VAS - when biting hard food&#xD;
VAS - at maximal mouth opening range (MMO)&#xD;
VAS of pressure pain- measured at the three most painful pressure points.&#xD;
1,2, and 5 are also measured after each treatment session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal mouth opening range (MMO)</measure>
    <time_frame>Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>Measurements will be taken before the first session and at the follow-up.</time_frame>
    <description>SF-36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Temporomandibular Joint Disorders</condition>
  <arm_group>
    <arm_group_label>Nocipoint Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nocipoint therapy (NT) follows rules of TENS stimulation in each session, all within the general FDA guidelines of TENS uses. The key points of Nocipoint Therapy include the following:&#xD;
The stimulation pads are located at the skin surface location of the nociceptors of the muscle/tissue in pain (i.e., &quot;Nocipoint&quot;)&#xD;
The intensity is set to induce C-fiber response during the stimulation&#xD;
The duration of stimulation (about 1.5-4 minutes for each tissue stimulation)&#xD;
Stimulations for different tissues (muscles, ligaments) are sequenced such that later stimulations will not cause re-injury of previously treated tissues.&#xD;
Patient are instructed not to use the newly recovered muscle/tissue too much for an estimated &quot;rest period&quot; depending on his/her age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will be treated with comprehensive physical therapy program including typical electrical stimulation using a standard transcutaneous electrical nerve stimulation (TENS) device, manual myofascial release and postural correction exercise.&#xD;
The application of TENS will follow general physical therapy guidelines, especially for TMD. Manual myofacial release will be applied on orofacial muscles and neck muscles.&#xD;
TENS will serve both as a part of the standard of care and as placebo, as the same TENS device is used in both arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nocipoint Therapy</intervention_name>
    <arm_group_label>Nocipoint Therapy</arm_group_label>
    <other_name>Charles Koo's Pain Cure Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <arm_group_label>Physical Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-65 years old female or male&#xD;
&#xD;
          -  Diagnosed as MFP subtype of TMD according to RDC/TMD&#xD;
&#xD;
          -  Pain duration over 3 month&#xD;
&#xD;
          -  Tender point in masseter&#xD;
&#xD;
          -  Asymmetrical pain intensity&#xD;
&#xD;
          -  Subsided symptoms of joint inflammation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic TMD from external impact force&#xD;
&#xD;
          -  History of traumatic cervical injury&#xD;
&#xD;
          -  Presence of systemic disease&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Co-interventions for cervical problems or TMD during study period&#xD;
&#xD;
          -  Signs of psychosomatic illness&#xD;
&#xD;
          -  Unwilling to be randomized&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alex YJ Chen, DDS, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charles C Koo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University and Pain Cure Center California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jau-Yih Tsauo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wan-Ling Kuo, BS</last_name>
    <phone>+886-0919-306-856</phone>
    <email>lingerkuo@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Charlie Koo, PhD</last_name>
    <phone>+1-6504248818</phone>
    <email>charlie.koo@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wan-Ling Kuo, BS</last_name>
      <phone>+886-0919-306-856</phone>
      <email>lingerkuo@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Charles C. Koo, PhD</last_name>
      <phone>+1-650-996-8168</phone>
      <email>charlie.koo@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Alex YJ Chen, DDS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Charles C Koo, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jau-Yih Tsauo, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.gov/ct2/show/NCT01578148?term=pain+cure+center+california&amp;rank=1</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>temporomandibular joint disorders</keyword>
  <keyword>nocipoint</keyword>
  <keyword>physical therapy</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>
  <!-- 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/NCT01676129
org study id: 101R104054-TMJ
nct id: NCT01676129
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to measure the effect of nocipoint therapy on patients with
      temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical
      stimulation therapy.
The prevalence of temporomandibular disorders (TMD) is about 20% to 60% of dental patients.
      Most patients suffer from myofascial pain (MFP) subtype of TMD. Analgesics, local muscle
      injection or oral appliance are often used to treat TMD-related MFP. Patients are also
      referred to physical therapists frequently. Many physical therapy (PT) modalities and
      techniques are applied to these patients, including non-invasive transcutaneous electrical
      nerve stimulation (TENS) using TENS devices. However, the exact application of TENS devices,
      including the location of the stimulation, duration and intensity of stimulation, is largely
      decided by physical therapists. Nocipoint Therapy, a unique combination of precise location,
      duration and intensity of TENS has been found to substantially relieve general myofascial
      pain and recover the muscle function with lasting effect.

      In preliminary observations of clinical applications, Nocipoint Therapy has been found to
      rapidly and substantially relieve TMD-related MFP within 2-3 sessions of the treatment.

      This clinical study compares the effect of Nocipoint Therapy on TMD with that of standard
      Physical therapy (PT). TENS will be used in the control group both as a part of the standard
      of care (i.e., PT) and as placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Visual Analog Scale (VAS) for pain
time frame: Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session
description: VAS is measured before each treatment session and at the follow-up:
VAS - overall
VAS - most painful
VAS - when biting hard food
VAS - at maximal mouth opening range (MMO)
VAS of pressure pain- measured at the three most painful pressure points.
1,2, and 5 are also measured after each treatment session.
measure: Maximal mouth opening range (MMO)
time frame: Measurements will be taken before and after each session, and at the follow-up, which is about 4 to 6 weeks after the last session
measure: Quality of Life (QoL)
time frame: Measurements will be taken before the first session and at the follow-up.
description: SF-36
arm group label: Nocipoint Therapy
arm group type: Experimental
description: Nocipoint therapy (NT) follows rules of TENS stimulation in each session, all within the general FDA guidelines of TENS uses. The key points of Nocipoint Therapy include the following:
The stimulation pads are located at the skin surface location of the nociceptors of the muscle/tissue in pain (i.e., "Nocipoint")
The intensity is set to induce C-fiber response during the stimulation
The duration of stimulation (about 1.5-4 minutes for each tissue stimulation)
Stimulations for different tissues (muscles, ligaments) are sequenced such that later stimulations will not cause re-injury of previously treated tissues.
Patient are instructed not to use the newly recovered muscle/tissue too much for an estimated "rest period" depending on his/her age.
arm group label: Physical Therapy
arm group type: Active Comparator
description: Patients in this group will be treated with comprehensive physical therapy program including typical electrical stimulation using a standard transcutaneous electrical nerve stimulation (TENS) device, manual myofascial release and postural correction exercise.
The application of TENS will follow general physical therapy guidelines, especially for TMD. Manual myofacial release will be applied on orofacial muscles and neck muscles.
TENS will serve both as a part of the standard of care and as placebo, as the same TENS device is used in both arms.
intervention type: Procedure
intervention name: Nocipoint Therapy
arm group label: Nocipoint Therapy
other name: Charles Koo's Pain Cure Therapy
intervention type: Procedure
intervention name: Physical Therapy
arm group label: Physical Therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alex YJ Chen, DDS, PHD
role: Principal Investigator
affiliation: National Taiwan University
last name: Charles C Koo, PhD
role: Principal Investigator
affiliation: National Taiwan University and Pain Cure Center California
last name: Jau-Yih Tsauo, PhD
role: Principal Investigator
affiliation: National Taiwan University
last name: Wan-Ling Kuo, BS
phone: +886-0919-306-856
email: lingerkuo@gmail.com
last name: Charlie Koo, PhD
phone: +1-6504248818
email: charlie.koo@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Taiwan
url: http://clinicaltrials.gov/ct2/show/NCT01578148?term=pain+cure+center+california&rank=1
description: Related Info
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome