<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/NCT01708343</url>
  </required_header>
  <id_info>
    <org_study_id>MPS-DIMS</org_study_id>
    <nct_id>NCT01708343</nct_id>
  </id_info>
  <brief_title>Paraspinal Stimulation in Treating MPS</brief_title>
  <acronym>DIMMST</acronym>
  <official_title>Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the hypothesis that the effect of either multiple deep intramuscular stimulation&#xD;
      therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep&#xD;
      intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a&#xD;
      placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for&#xD;
      improving pain relief, sleep quality, and physical and mental state of the patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain severity</measure>
    <time_frame>A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)</time_frame>
    <description>a) The intensity of pain was measured by a 10-cm VAS [30]. VAS scores ranged from no pain (zero) to the worst possible pain (10 cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)</time_frame>
    <description>Pain pressure threshold (PPT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep quality - how did you feel when you woke up</measure>
    <time_frame>A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)</time_frame>
    <description>Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:&#xD;
In general, how did you feel when you woke up?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality - compared to your habitual sleep</measure>
    <time_frame>A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)</time_frame>
    <description>Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:&#xD;
Assess the sleep quality of the previous night compared to your habitual sleep?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality -last night</measure>
    <time_frame>A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)</time_frame>
    <description>Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:&#xD;
How well did you sleep last night?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical and mental Health</measure>
    <time_frame>Before to begin treatment and after end treatment</time_frame>
    <description>Health-related quality of life, assessed at baseline and the end of treatment sessions, was measured with the SF-12 Summary Scales</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Clinical Study - RCT</condition>
  <arm_group>
    <arm_group_label>Placebo-sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Placebo-sham twice a week during four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DIMMST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR).&#xD;
Twice a week during four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DIMMST</intervention_name>
    <arm_group_label>DIMMST</arm_group_label>
    <arm_group_label>Lidocaine injection</arm_group_label>
    <arm_group_label>Placebo-sham</arm_group_label>
    <other_name>Eletroacupuncture</other_name>
    <other_name>Myofascial pain</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic&#xD;
             examination, presence of TrPs, taut bands, tender points, and pain characterized as&#xD;
             &quot;dull,&quot; &quot;achy,&quot; or &quot;deep&quot; were relevant to MPS diagnosis. Additionally, palpable&#xD;
             nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness&#xD;
             in the muscle).&#xD;
&#xD;
          -  Disability in the last three months: (defined if they had one or more these limitation&#xD;
             in active and routine activities by MPS : (i) interference with work, (ii) enjoyable&#xD;
             activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals,&#xD;
             (vi) thinking clearly, and problem solving, concentrating, or remembering during the&#xD;
             last three months).&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Age: 19 to 50 years&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        Rheumatoid arthritis&#xD;
&#xD;
        Fibromyalgia&#xD;
&#xD;
        Previous surgery on the affected areas&#xD;
&#xD;
        Prior experience with acupuncture&#xD;
&#xD;
        Primary radiculopathy&#xD;
&#xD;
        Current use of psychotropic drugs (ilicits&#xD;
&#xD;
        ) Habitual use of anti-inflammatory steroids.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>WOLNEI CAUMO, MD, PhD</last_name>
    <phone>55-51-3359-8083</phone>
    <email>caumo@cpovo.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>CAUMO, MD., PhD</last_name>
    <phone>55-51-3359-8083</phone>
    <email>caumo@cpovo.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose R Goldim, PhD</last_name>
      <phone>55 (51) 3359-8856.</phone>
      <email>jrgoldim@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Iraci L Torres, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Felipe Fregni, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose R Goldim, PhD</last_name>
      <phone>55 (51) 3359-8856</phone>
      <email>jrgoldim@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>José R Goldim, PhD</last_name>
      <phone>55 (51) 3359-8856</phone>
      <email>jrgoldim@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Wolnei Caumo, MD., PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>IRACI LS TORRES, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>FELIPE GREGNI, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas E Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JOSE GOLDIM, PhD</last_name>
      <phone>55 (51) 3359-8856.</phone>
      <email>jrgoldim@gmail.com</email>
    </contact>
    <investigator>
      <last_name>WOLNEI CAUMO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>Wolnei Caumo</investigator_full_name>
    <investigator_title>MD, PhD, Professor and coordinator of Pain &amp; Neuromodulation Lab</investigator_title>
  </responsible_party>
  <keyword>Myofascial Pain Syndrome,</keyword>
  <keyword>intramuscular stimulation,</keyword>
  <keyword>acupuncture,</keyword>
  <keyword>sleep quality,</keyword>
  <keyword>pain threshold.</keyword>
  <!-- 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/NCT01708343
org study id: MPS-DIMS
nct id: NCT01708343
lead sponsor: 
has dmc: Yes
To test the hypothesis that the effect of either multiple deep intramuscular stimulation
      therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep
      intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a
      placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for
      improving pain relief, sleep quality, and physical and mental state of the patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain severity
time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
description: a) The intensity of pain was measured by a 10-cm VAS [30]. VAS scores ranged from no pain (zero) to the worst possible pain (10 cm).
measure: Pain threshold
time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
description: Pain pressure threshold (PPT)
measure: Sleep quality - how did you feel when you woke up
time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
description: Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:
In general, how did you feel when you woke up?
measure: Sleep quality - compared to your habitual sleep
time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
description: Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:
Assess the sleep quality of the previous night compared to your habitual sleep?
measure: Sleep quality -last night
time frame: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
description: Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS:
How well did you sleep last night?
measure: Physical and mental Health
time frame: Before to begin treatment and after end treatment
description: Health-related quality of life, assessed at baseline and the end of treatment sessions, was measured with the SF-12 Summary Scales
arm group label: Placebo-sham
arm group type: Sham Comparator
description: Placebo-sham twice a week during four weeks
arm group label: Lidocaine injection
arm group type: Active Comparator
description: Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks
arm group label: DIMMST
arm group type: Experimental
description: DIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR).
Twice a week during four weeks
intervention type: Procedure
intervention name: DIMMST
arm group label: DIMMST
arm group label: Lidocaine injection
arm group label: Placebo-sham
other name: Eletroacupuncture
other name: Myofascial pain
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: WOLNEI CAUMO, MD, PhD
phone: 55-51-3359-8083
email: caumo@cpovo.net
last name: CAUMO, MD., PhD
phone: 55-51-3359-8083
email: caumo@cpovo.net
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: Wolnei Caumo
investigator title: MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab