<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/NCT03043625</url>
  </required_header>
  <id_info>
    <org_study_id>VM-2016</org_study_id>
    <nct_id>NCT03043625</nct_id>
  </id_info>
  <brief_title>Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia</brief_title>
  <official_title>Effect of Visceral Manipulation on Electromyographic Activity of the Upper Trapezius Muscle, Cervical Range and Pain in Patients With Non-specific Neck Pain With Functional Dyspepsia: A Randomized, Double-blinded, Sham-controlled, Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Andréia Cristina de Oliveira Silva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Claudia Santos Oliveira</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daniela Aparecida Biasotto-Gonzalez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marco Antônio Fumagalli</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cid André Fidelis de Paula Gomes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>Yes</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: Non-specific neck pain (NS-NP) is characterized by pain in structures located in&#xD;
      the region between the superior nuchal line and the spinal process of the first thoracic&#xD;
      vertebra, without association with any specific systemic disease provided by multifactorial&#xD;
      and/or little known causes.&#xD;
&#xD;
      Objective: The objective of the present study will be to verify the clinical effects of MV&#xD;
      through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.&#xD;
&#xD;
      Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years)&#xD;
      will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control&#xD;
      group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and&#xD;
      liver wile CG received placebo treatment. The immediate effects and 7 days after treatment&#xD;
      will be evaluated through pain, cervical range, and electromyographic activity of the upper&#xD;
      trapezius.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">February 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</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>randomized, double-blinded, sham-controlled, study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity assessed with Numerical Rating Scale</measure>
    <time_frame>12 months</time_frame>
    <description>Numerical rating scale (NRS) (11 point; 0: no pain, 10: the worst possible pain imaginable) translated and cross-culturally adapted for the Brazilian population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain area documented on a body chart</measure>
    <time_frame>12 months</time_frame>
    <description>Pain area will documented on a body chart. The drawings will be subsequently digitized and pain areas will be measured using open source software named ImageJ (version 1.43, National Institutes of Health, Bethesda, Maryland).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electromyography</measure>
    <time_frame>12 months</time_frame>
    <description>The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical range of motion</measure>
    <time_frame>12 months</time_frame>
    <description>A flexometer (Sami ®) will be used to verify cervical range of motion (ROM) of the flexion/extension, right and left lateral flexion and rotation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Neck Pain</condition>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>Visceral manipulation Group (VMG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The VMG wil be treated with visceral manipulation to the stomach and liver</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (CG)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visceral manipulation</intervention_name>
    <description>Participants will be instructed to lie down comfortably on a stretcher in the supine position, with lower limbs flexed and abdomen exposed, and the physiotherapist positioned to the right side of the patient. The therapeutic intervention will be began with the left hand of the physiotherapist in contact with the lower region of the stomach, to which a force will be applied so that the organ was moved in an upper and lateral left direction while the right hand controlled and directed the knees of the patient to the right side until the moment when the physiotherapist notice an increase in tension in the stomach region. For the liver manipulation, the same procedures will be followed, however, with contact in the right epigastric region and the knees directed to the left side. The same position will be maintained for each organ treated until the physiotherapist could feel, through touch, a decrease in the tension of the viscera. The mean treatment time will 5 minutes.</description>
    <arm_group_label>Visceral manipulation Group (VMG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group (CG)</intervention_name>
    <description>The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.</description>
    <arm_group_label>Control group (CG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of neck pain for a minimal period of the three months;&#xD;
&#xD;
          -  neck with restricted movement (active or passive) in at least one direction;&#xD;
&#xD;
          -  Neck Disability Index considering score range of 11-24 (score out of a 50) ;&#xD;
&#xD;
          -  numerical rating scale (NRS) for perceived pain intensity considering 3-7 points on an&#xD;
             11-point;&#xD;
&#xD;
          -  Presence of symptoms related to functional dyspepsia, according to the Rome III&#xD;
             diagnostic criteria: uncomfortable postprandial fullness, early satiety, epigastric&#xD;
             pain and epigastric burning, accompanied by no evidence of structural disease capable&#xD;
             of explaining the symptoms .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with history of neurological disorders (i.e., irradiated pain) or neck&#xD;
             surgery; systemic disease; connective tissue disorder and herniated disc;&#xD;
&#xD;
          -  current pregnancy;&#xD;
&#xD;
          -  medical diagnosis of fibromyalgia;&#xD;
&#xD;
          -  physical therapy treatment with, massage, or acupuncture in the previous two weeks;&#xD;
&#xD;
          -  use of analgesic, muscle relaxant, psychotropic agent, or anti-inflammatory agent in&#xD;
             the previous three days;&#xD;
&#xD;
          -  chronic neck pain resulting from a traumatic incident; chronic musculoskeletal&#xD;
             condition (e.g., muscular disorder, polyarthritis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.</citation>
    <PMID>17369782</PMID>
  </reference>
  <results_reference>
    <citation>Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.</citation>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Fabiano Politti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>visceral manipulation</keyword>
  <keyword>functional dyspepsia</keyword>
  <keyword>electromyography</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data will not be shared with other researchers. The results of the study will be published as a manuscript in a scientific journal.</ipd_description>
  </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/NCT03043625
org study id: VM-2016
nct id: NCT03043625
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Non-specific neck pain (NS-NP) is characterized by pain in structures located in
      the region between the superior nuchal line and the spinal process of the first thoracic
      vertebra, without association with any specific systemic disease provided by multifactorial
      and/or little known causes.

      Objective: The objective of the present study will be to verify the clinical effects of MV
      through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.

      Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years)
      will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control
      group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and
      liver wile CG received placebo treatment. The immediate effects and 7 days after treatment
      will be evaluated through pain, cervical range, and electromyographic activity of the upper
      trapezius.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, double-blinded, sham-controlled, study
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain intensity assessed with Numerical Rating Scale
time frame: 12 months
description: Numerical rating scale (NRS) (11 point; 0: no pain, 10: the worst possible pain imaginable) translated and cross-culturally adapted for the Brazilian population
measure: Pain area documented on a body chart
time frame: 12 months
description: Pain area will documented on a body chart. The drawings will be subsequently digitized and pain areas will be measured using open source software named ImageJ (version 1.43, National Institutes of Health, Bethesda, Maryland).
measure: Electromyography
time frame: 12 months
description: The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.
measure: Cervical range of motion
time frame: 12 months
description: A flexometer (Sami ®) will be used to verify cervical range of motion (ROM) of the flexion/extension, right and left lateral flexion and rotation.
arm group label: Visceral manipulation Group (VMG)
arm group type: Experimental
description: The VMG wil be treated with visceral manipulation to the stomach and liver
arm group label: Control group (CG)
arm group type: Placebo Comparator
description: The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.
intervention type: Other
intervention name: Visceral manipulation
description: Participants will be instructed to lie down comfortably on a stretcher in the supine position, with lower limbs flexed and abdomen exposed, and the physiotherapist positioned to the right side of the patient. The therapeutic intervention will be began with the left hand of the physiotherapist in contact with the lower region of the stomach, to which a force will be applied so that the organ was moved in an upper and lateral left direction while the right hand controlled and directed the knees of the patient to the right side until the moment when the physiotherapist notice an increase in tension in the stomach region. For the liver manipulation, the same procedures will be followed, however, with contact in the right epigastric region and the knees directed to the left side. The same position will be maintained for each organ treated until the physiotherapist could feel, through touch, a decrease in the tension of the viscera. The mean treatment time will 5 minutes.
arm group label: Visceral manipulation Group (VMG)
intervention type: Other
intervention name: Control group (CG)
description: The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.
arm group label: Control group (CG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
citation: Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
PMID: 17369782
citation: Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Fabiano Politti
investigator title: Principal Investigator
mesh term: Neck Pain
mesh term: Dyspepsia
sharing ipd: No
ipd description: The data will not be shared with other researchers. The results of the study will be published as a manuscript in a scientific journal.