<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/NCT03830346</url>
  </required_header>
  <id_info>
    <org_study_id>MJ-IASTM</org_study_id>
    <nct_id>NCT03830346</nct_id>
  </id_info>
  <brief_title>Instrument-assisted Soft Tissue Mobilization in CrossFitters</brief_title>
  <acronym>MJ-IASTM</acronym>
  <official_title>Instrument-assisted Soft Tissue Mobilization and Stretching in CrossFitters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Real Fundación Victoria Eugenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Real Fundación Victoria Eugenia</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>
      Objective. To determine the effectiveness of instrument assisted soft tissue mobilization and&#xD;
      horizontal adduction stretch in CrossFit practitioners' shoulders.&#xD;
&#xD;
      Setting: Acero CrossFit center, city of Toledo (Spain) Design: Randomized, single-blind pilot&#xD;
      study, with follow-up period. Participants: Twenty-one subjects of both sexes, being regular&#xD;
      CrossFitters and in the age range of 18 to 40 years.&#xD;
&#xD;
      Intervention: The experimental group (n = 11) received 30 seconds of stretching with&#xD;
      isometric contraction of 5 seconds and instrument assisted soft tissue mobilization. The&#xD;
      control group (n = 10) received only 40 seconds of instrument assisted soft tissue&#xD;
      mobilization. Each session lasted 2 to 5 minutes, 2 days a week, over a period of 4 weeks,&#xD;
      prior to each workout.&#xD;
&#xD;
      Main Outcome measures: Shoulder internal rotation and horizontal adduction (digital&#xD;
      inclinometer), and posterior shoulder stretch perception (Park scale) were evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline internal rotation and horizontal adduction of the shoulder after treatment and at 1 month</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after one month follow-up visit</time_frame>
    <description>The patient was placed in the supine position at 90º shoulder abduction, 90º elbow flexion. By stabilizing the scapula at the acromion, the shoulder was taken at a maximum range of internal rotation. The range of motion was measured with a digital inclinometer, model Tacklife MDP01, the angle of the edge of the ulna coinciding with a line perpendicular to the stretcher. For horizontal adduction, the arm was placed in the same initial position in neutral rotation and while stabilizing the lateral edge of the scapula, the arm was adducted to its maximum range of motion. The angle between the line of the ventral edge of the humerus and a line perpendicular to the stretcher was measured with the inclinometer. The range of movement in internal rotation is 0-70º and the range in horizontal adduction is 0-30º (higher degrees, greater mobility in horizontal adduction of the shoulder).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline perception of stretch after treatment and at 1 month</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after one month follow-up visit</time_frame>
    <description>An 11-point numerical rating scale was used to rate subjects' perceptions of discomfort at the posterior aspect of the shoulder. This 11-point scale evaluates the discomfort from least to most, asking each subject to define the level of discomfort in the back of the shoulder in the maximum range of motion of internal rotation and horizontal adduction of the shoulder. This 11-point scale measures the perception of stretching, in a range of 0 to 10 points (&quot;0&quot; on the stretch sensation scale indicated ''no discomfort'' and &quot;10&quot; indicated ''the worst possible discomfort and increased sensitivity')</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Sports Physical Therapy</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental group, instrument-assisted soft tissue mobilization techniques and post-isometric horizontal adduction stretches were performed. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control group only underwent soft tissue mobilization. With the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Instrument-assisted</intervention_name>
    <description>instrument-assisted soft tissue mobilization techniques (applied with the subject in prone position. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment) and post-isometric horizontal adduction stretches (carried out with the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times).</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of both sexes&#xD;
&#xD;
          -  Being regular CrossFitters (workouts at least two days a week)&#xD;
&#xD;
          -  In the age range of 18 to 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had suffered a shoulder injury in the 3 months prior to the study&#xD;
&#xD;
          -  Had undergone shoulder surgery in the previous six months&#xD;
&#xD;
          -  Had a non-attendance rate of over 15% of the intervention sessions (2 sessions)&#xD;
&#xD;
          -  Had not signed the informed consent document&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rubén Cuesta-Barriuso, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Europea de Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Real Fundación Victoria Eugenia</name>
      <address>
        <city>Madrid</city>
        <zip>28029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Instrument Assisted Soft Tissue Mobilization</keyword>
  <keyword>Manual Therapy</keyword>
  <keyword>Muscle Stretching Exercises</keyword>
  <keyword>Range of motion</keyword>
  <keyword>Shoulder Joint</keyword>
  <keyword>CrossFit</keyword>
  <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/NCT03830346
org study id: MJ-IASTM
nct id: NCT03830346
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective. To determine the effectiveness of instrument assisted soft tissue mobilization and
      horizontal adduction stretch in CrossFit practitioners' shoulders.

      Setting: Acero CrossFit center, city of Toledo (Spain) Design: Randomized, single-blind pilot
      study, with follow-up period. Participants: Twenty-one subjects of both sexes, being regular
      CrossFitters and in the age range of 18 to 40 years.

      Intervention: The experimental group (n = 11) received 30 seconds of stretching with
      isometric contraction of 5 seconds and instrument assisted soft tissue mobilization. The
      control group (n = 10) received only 40 seconds of instrument assisted soft tissue
      mobilization. Each session lasted 2 to 5 minutes, 2 days a week, over a period of 4 weeks,
      prior to each workout.

      Main Outcome measures: Shoulder internal rotation and horizontal adduction (digital
      inclinometer), and posterior shoulder stretch perception (Park scale) were evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change from baseline internal rotation and horizontal adduction of the shoulder after treatment and at 1 month
time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
description: The patient was placed in the supine position at 90º shoulder abduction, 90º elbow flexion. By stabilizing the scapula at the acromion, the shoulder was taken at a maximum range of internal rotation. The range of motion was measured with a digital inclinometer, model Tacklife MDP01, the angle of the edge of the ulna coinciding with a line perpendicular to the stretcher. For horizontal adduction, the arm was placed in the same initial position in neutral rotation and while stabilizing the lateral edge of the scapula, the arm was adducted to its maximum range of motion. The angle between the line of the ventral edge of the humerus and a line perpendicular to the stretcher was measured with the inclinometer. The range of movement in internal rotation is 0-70º and the range in horizontal adduction is 0-30º (higher degrees, greater mobility in horizontal adduction of the shoulder).
measure: Change from baseline perception of stretch after treatment and at 1 month
time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
description: An 11-point numerical rating scale was used to rate subjects' perceptions of discomfort at the posterior aspect of the shoulder. This 11-point scale evaluates the discomfort from least to most, asking each subject to define the level of discomfort in the back of the shoulder in the maximum range of motion of internal rotation and horizontal adduction of the shoulder. This 11-point scale measures the perception of stretching, in a range of 0 to 10 points ("0" on the stretch sensation scale indicated ''no discomfort'' and "10" indicated ''the worst possible discomfort and increased sensitivity')
arm group label: Experimental
arm group type: Experimental
description: In the experimental group, instrument-assisted soft tissue mobilization techniques and post-isometric horizontal adduction stretches were performed. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment.
arm group label: Control
arm group type: Experimental
description: Control group only underwent soft tissue mobilization. With the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times.
intervention type: Other
intervention name: Instrument-assisted
description: instrument-assisted soft tissue mobilization techniques (applied with the subject in prone position. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment) and post-isometric horizontal adduction stretches (carried out with the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times).
arm group label: Control
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rubén Cuesta-Barriuso, PhD
role: Principal Investigator
affiliation: Universidad Europea de Madrid
facility: 
country: Spain
responsible party type: Sponsor
sharing ipd: No