<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/NCT04501575</url>
  </required_header>
  <id_info>
    <org_study_id>UPorto_DemSSO_RS</org_study_id>
    <nct_id>NCT04501575</nct_id>
  </id_info>
  <brief_title>Feasibility of RCT on the Efficacy of the Osteopathic Consultation in Computer Users</brief_title>
  <official_title>A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain in Computer Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Porto</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>
      This study investigates the feasibility of conducting a large scale Randomized Controlled&#xD;
      Trial (RCT) to analyze the efficacy of the osteopathic consultation in reducing the intensity&#xD;
      of pain and changing electromyographic activity in the musculature of the neck-shoulder&#xD;
      region for the computer user's population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in electrical activity during typing task using surface electromyography</measure>
    <time_frame>baseline and after 2-4 days of the treatment</time_frame>
    <description>Surface electromyography (sEMG) was used to retrieve the electrical activity of the Upper Trapezius (UT) muscles. The electrical signal was normalized through the maximum isometric voluntary contraction (MIVC) and expressed as a percentage of MIVC. sEMG data will be collect at 4 different moments of the 15 minutes typing task. Electrodes placement, data collection and processing was performed according to SENIAM standards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in Pressure-pain Threshold (PPT)</measure>
    <time_frame>baseline and after 2-4 days of the treatment</time_frame>
    <description>A Digital Pressure Algometer (Wagner FORCE ONE FDIX 50', Wagner Instruments, Greenwich, CT, USA) was used on the trapezius muscle, superior fibers, both sides. The exact location on the muscles was defined as 2cm above the medial electrode, on the muscle fiber direction. During the collection of the PPT, the participant stopped the typing task and rested arms on the legs. The algometer pointer was placed perpendicular to the points marked for evaluation, and then, vertical compression force was applied. That force was increased continuously at a rate of 1 kg/cm2 until pain was reported. Measurements were made in the seating position, immediately before and after the writing task. To ensure the maximum reading was obtained, the C-Peak option of the device was enabled. Participants were instructed of the procedures in advance, and simulation on their forearm was performed before the data collection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in the self-reported intensity of pain using the numerical rating scale (NRS)</measure>
    <time_frame>baseline, after 2-4 days of the treatment and after 1 week of the treatment</time_frame>
    <description>This numeric scale, is used on its 11-point version. NRS represents a simple, 1-dimensional measuring instrument for the assessment of pain intensity (0 = no pain, 10 = unbearable pain). Participants were asked to visualize the quantity of pain they were experiencing at that precise moment over the shoulder-neck region, both sides.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Level with the experience</measure>
    <time_frame>1 week after data collection for all participants.</time_frame>
    <description>This questionnaire aims at retrieving satisfaction levels with the recruitment and data collection processes. It was adapted from the one used by Pflugeisen et al., (2016).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Trapezius Muscle Strain</condition>
  <arm_group>
    <arm_group_label>Osteopathic consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It consists of 1 session. Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteopathic sham consultation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Osteopathic Sham treatment was applied using manual contact on specific bony surfaces using very light pressure. The practitioner was counting the seconds up to 1 minute between the areas where to apply the light touch without any intention to treat or diagnose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be on a waiting list, and meanwhile, they are advised to deal with their pain in the way they would, but without using any sort of Manual Therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic Consultation</intervention_name>
    <description>A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.</description>
    <arm_group_label>Osteopathic consultation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Osteopathic Consultation</intervention_name>
    <description>A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions</description>
    <arm_group_label>Osteopathic sham consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uses computer for over five hours daily, for over one year&#xD;
&#xD;
          -  Reports non-specific pain over the neck-shoulder region&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No neurologic signs or symptoms&#xD;
&#xD;
          -  No known pathology that could mask the reported pain&#xD;
&#xD;
          -  No knowledge or experience with osteopathy&#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>José Torres da Costa, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Labiomep</name>
      <address>
        <city>Porto</city>
        <zip>4200-450</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Porto</investigator_affiliation>
    <investigator_full_name>Rui José Gomes de Pinho Santiago</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <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/NCT04501575
org study id: UPorto_DemSSO_RS
nct id: NCT04501575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the feasibility of conducting a large scale Randomized Controlled
      Trial (RCT) to analyze the efficacy of the osteopathic consultation in reducing the intensity
      of pain and changing electromyographic activity in the musculature of the neck-shoulder
      region for the computer user's population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Differences in electrical activity during typing task using surface electromyography
time frame: baseline and after 2-4 days of the treatment
description: Surface electromyography (sEMG) was used to retrieve the electrical activity of the Upper Trapezius (UT) muscles. The electrical signal was normalized through the maximum isometric voluntary contraction (MIVC) and expressed as a percentage of MIVC. sEMG data will be collect at 4 different moments of the 15 minutes typing task. Electrodes placement, data collection and processing was performed according to SENIAM standards.
measure: Differences in Pressure-pain Threshold (PPT)
time frame: baseline and after 2-4 days of the treatment
description: A Digital Pressure Algometer (Wagner FORCE ONE FDIX 50', Wagner Instruments, Greenwich, CT, USA) was used on the trapezius muscle, superior fibers, both sides. The exact location on the muscles was defined as 2cm above the medial electrode, on the muscle fiber direction. During the collection of the PPT, the participant stopped the typing task and rested arms on the legs. The algometer pointer was placed perpendicular to the points marked for evaluation, and then, vertical compression force was applied. That force was increased continuously at a rate of 1 kg/cm2 until pain was reported. Measurements were made in the seating position, immediately before and after the writing task. To ensure the maximum reading was obtained, the C-Peak option of the device was enabled. Participants were instructed of the procedures in advance, and simulation on their forearm was performed before the data collection.
measure: Difference in the self-reported intensity of pain using the numerical rating scale (NRS)
time frame: baseline, after 2-4 days of the treatment and after 1 week of the treatment
description: This numeric scale, is used on its 11-point version. NRS represents a simple, 1-dimensional measuring instrument for the assessment of pain intensity (0 = no pain, 10 = unbearable pain). Participants were asked to visualize the quantity of pain they were experiencing at that precise moment over the shoulder-neck region, both sides.
measure: Satisfaction Level with the experience
time frame: 1 week after data collection for all participants.
description: This questionnaire aims at retrieving satisfaction levels with the recruitment and data collection processes. It was adapted from the one used by Pflugeisen et al., (2016).
arm group label: Osteopathic consultation
arm group type: Experimental
description: It consists of 1 session. Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains
arm group label: Osteopathic sham consultation
arm group type: Sham Comparator
description: Osteopathic Sham treatment was applied using manual contact on specific bony surfaces using very light pressure. The practitioner was counting the seconds up to 1 minute between the areas where to apply the light touch without any intention to treat or diagnose.
arm group label: Usual Care
arm group type: No Intervention
description: Participants will be on a waiting list, and meanwhile, they are advised to deal with their pain in the way they would, but without using any sort of Manual Therapy.
intervention type: Other
intervention name: Osteopathic Consultation
description: A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.
arm group label: Osteopathic consultation
intervention type: Other
intervention name: Sham Osteopathic Consultation
description: A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions
arm group label: Osteopathic sham consultation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: José Torres da Costa, Professor
role: Principal Investigator
affiliation: Professor
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Universidade do Porto
investigator full name: Rui José Gomes de Pinho Santiago
investigator title: PhD Student
sharing ipd: No