<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/NCT03762720</url>
  </required_header>
  <id_info>
    <org_study_id>Muscle injuries</org_study_id>
    <nct_id>NCT03762720</nct_id>
  </id_info>
  <brief_title>Treatment of Muscle Injuries With Physium Therapy.</brief_title>
  <acronym>Physium</acronym>
  <official_title>Treatment of Muscle Injuries With Physium Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cadiz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cadiz</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscle injuries are currently particularly frequent among people who participate in sports.&#xD;
&#xD;
      The diagnosis is easily made with an ultrasound study and Shear Wave Elastography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients of the experimental group, after diagnosis by ultrasound and Shear Wave Elastography&#xD;
      , will receive five sessions of physium therapy at 80 millibars during one month.&#xD;
&#xD;
      The measurements of the variables visual analog scale, joint mobility through the double&#xD;
      inclinometer device, elasticity and tissue vascularization through the ultrasound, quality of&#xD;
      life through SF-12 questionnaire and pressure algometry will be made before, after, month and&#xD;
      three months after the end of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2019</start_date>
  <completion_date type="Anticipated">August 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Blind researcher</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time necessary to return to full sport participation.</measure>
    <time_frame>Baseline</time_frame>
    <description>Time necessary to return to full sport participation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time necessary to return to full sport participation.</measure>
    <time_frame>Four weeks.</time_frame>
    <description>Time necessary to return to full sport participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion.</measure>
    <time_frame>Baseline and four weeks</time_frame>
    <description>Measured by goniometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The intensity of pain</measure>
    <time_frame>Baseline and four weeks</time_frame>
    <description>A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding week in the area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain thresholds in cervical trigger points</measure>
    <time_frame>Baseline and four weeks</time_frame>
    <description>Pressure pain thresholds (PPTs) will be measured with a pressure algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire SF 12</measure>
    <time_frame>Baseline and four weeks</time_frame>
    <description>The multidimensional health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the extent of sports-related muscle injuries</measure>
    <time_frame>Baseline and four weeks</time_frame>
    <description>Imaging is crucial to confirm and assess the extent of sports-related muscle injuries and may help to guide management.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Injuries; Muscle, Nontraumatic</condition>
  <arm_group>
    <arm_group_label>Physium treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Physium treatment</intervention_name>
    <description>patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for one month in muscle injury and diagnosed by ultrasound and Shear Wave Elastography.</description>
    <arm_group_label>Physium treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both sexes, aged between 20 and 60 years, in an active state of pain and&#xD;
             diagnosed with muscle breakdown.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant, have pacemakers and surgically operated in the area to be&#xD;
             treated.&#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>Manuel Rodriguez Huguet, Physiotherapy</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manuel Rodriguez Huguet, Physiotherapy</last_name>
    <phone>+34606176814</phone>
    <email>manuel.rodriguez@uca.es</email>
  </overall_contact>
  <reference>
    <citation>Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.</citation>
    <PMID>23536466</PMID>
  </reference>
  <reference>
    <citation>Guermazi A, Roemer FW, Robinson P, Tol JL, Regatte RR, Crema MD. Imaging of Muscle Injuries in Sports Medicine: Sports Imaging Series. Radiology. 2017 Dec;285(3):1063. doi: 10.1148/radiol.2017174038. No abstract available.</citation>
    <PMID>29155622</PMID>
  </reference>
  <reference>
    <citation>Lee JC, Mitchell AW, Healy JC. Imaging of muscle injury in the elite athlete. Br J Radiol. 2012 Aug;85(1016):1173-85. doi: 10.1259/bjr/84622172. Epub 2012 Apr 11.</citation>
    <PMID>22496067</PMID>
  </reference>
  <reference>
    <citation>Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.</citation>
    <PMID>23045734</PMID>
  </reference>
  <reference>
    <citation>Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.</citation>
    <PMID>19130648</PMID>
  </reference>
  <reference>
    <citation>Bonilla D, Hortalá G, Temporal D, CarréLlopis C. PHYSIUM in thetreatment of pain in patientswithchroniclow back pain. FisioGlía. 2015;2(3):50-55.</citation>
  </reference>
  <reference>
    <citation>Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.</citation>
    <PMID>14987620</PMID>
  </reference>
  <reference>
    <citation>Ko SJ, Kim H, Kim SK, Park K, Lee J, Lee BJ, Oh J, Lee K, Park JW. Reliability and Validity of Modified Algometer in Abdominal Examination. Evid Based Complement Alternat Med. 2016;2016:3052954. doi: 10.1155/2016/3052954. Epub 2016 Mar 17.</citation>
    <PMID>27073401</PMID>
  </reference>
  <reference>
    <citation>Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.</citation>
    <PMID>12583868</PMID>
  </reference>
  <reference>
    <citation>Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.</citation>
    <PMID>18570798</PMID>
  </reference>
  <reference>
    <citation>Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.</citation>
    <PMID>6226917</PMID>
  </reference>
  <reference>
    <citation>Ayala F, De Ste Croix M, Sainz de Baranda P, Santonja F. Acute effects of static and dynamic stretching on hamstrings' response times. J Sports Sci. 2014;32(9):817-25. doi: 10.1080/02640414.2013.861606. Epub 2014 Jan 10.</citation>
    <PMID>24405028</PMID>
  </reference>
  <reference>
    <citation>Ohno Y, Fujimoto T, Shibata Y. A New Era in Diagnostic Ultrasound, Superb Microvascular Imaging: Preliminary Results in Pediatric Hepato-Gastrointestinal Disorders. Eur J Pediatr Surg. 2017 Feb;27(1):20-25. doi: 10.1055/s-0036-1593381. Epub 2016 Oct 3.</citation>
    <PMID>27699732</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cadiz</investigator_affiliation>
    <investigator_full_name>Manuel Rodriguez Huguet</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Manual Therapy</keyword>
  <keyword>Massage</keyword>
  <keyword>physium</keyword>
  <keyword>pain</keyword>
  <keyword>range of motion</keyword>
  <keyword>quality of life</keyword>
  <keyword>muscle injuries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT03762720
org study id: Muscle injuries
nct id: NCT03762720
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Muscle injuries are currently particularly frequent among people who participate in sports.

      The diagnosis is easily made with an ultrasound study and Shear Wave Elastography.
Patients of the experimental group, after diagnosis by ultrasound and Shear Wave Elastography
      , will receive five sessions of physium therapy at 80 millibars during one month.

      The measurements of the variables visual analog scale, joint mobility through the double
      inclinometer device, elasticity and tissue vascularization through the ultrasound, quality of
      life through SF-12 questionnaire and pressure algometry will be made before, after, month and
      three months after the end of treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
primary purpose: Treatment
masking: None (Open Label)
masking description: Blind researcher
measure: Time necessary to return to full sport participation.
time frame: Baseline
description: Time necessary to return to full sport participation.
measure: Time necessary to return to full sport participation.
time frame: Four weeks.
description: Time necessary to return to full sport participation.
measure: Range of motion.
time frame: Baseline and four weeks
description: Measured by goniometer.
measure: The intensity of pain
time frame: Baseline and four weeks
description: A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding week in the area.
measure: Pressure pain thresholds in cervical trigger points
time frame: Baseline and four weeks
description: Pressure pain thresholds (PPTs) will be measured with a pressure algometer
measure: Questionnaire SF 12
time frame: Baseline and four weeks
description: The multidimensional health related quality of life
measure: the extent of sports-related muscle injuries
time frame: Baseline and four weeks
description: Imaging is crucial to confirm and assess the extent of sports-related muscle injuries and may help to guide management.
arm group label: Physium treatment
arm group type: Experimental
description: Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month
intervention type: Device
intervention name: Physium treatment
description: patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for one month in muscle injury and diagnosed by ultrasound and Shear Wave Elastography.
arm group label: Physium treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Manuel Rodriguez Huguet, Physiotherapy
role: Principal Investigator
affiliation: University of Cadiz
last name: Manuel Rodriguez Huguet, Physiotherapy
phone: +34606176814
email: manuel.rodriguez@uca.es
citation: Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.
PMID: 23536466
citation: Guermazi A, Roemer FW, Robinson P, Tol JL, Regatte RR, Crema MD. Imaging of Muscle Injuries in Sports Medicine: Sports Imaging Series. Radiology. 2017 Dec;285(3):1063. doi: 10.1148/radiol.2017174038. No abstract available.
PMID: 29155622
citation: Lee JC, Mitchell AW, Healy JC. Imaging of muscle injury in the elite athlete. Br J Radiol. 2012 Aug;85(1016):1173-85. doi: 10.1259/bjr/84622172. Epub 2012 Apr 11.
PMID: 22496067
citation: Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.
PMID: 23045734
citation: Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.
PMID: 19130648
citation: Bonilla D, Hortalá G, Temporal D, CarréLlopis C. PHYSIUM in thetreatment of pain in patientswithchroniclow back pain. FisioGlía. 2015;2(3):50-55.
citation: Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.
PMID: 14987620
citation: Ko SJ, Kim H, Kim SK, Park K, Lee J, Lee BJ, Oh J, Lee K, Park JW. Reliability and Validity of Modified Algometer in Abdominal Examination. Evid Based Complement Alternat Med. 2016;2016:3052954. doi: 10.1155/2016/3052954. Epub 2016 Mar 17.
PMID: 27073401
citation: Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.
PMID: 12583868
citation: Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.
PMID: 18570798
citation: Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PMID: 6226917
citation: Ayala F, De Ste Croix M, Sainz de Baranda P, Santonja F. Acute effects of static and dynamic stretching on hamstrings' response times. J Sports Sci. 2014;32(9):817-25. doi: 10.1080/02640414.2013.861606. Epub 2014 Jan 10.
PMID: 24405028
citation: Ohno Y, Fujimoto T, Shibata Y. A New Era in Diagnostic Ultrasound, Superb Microvascular Imaging: Preliminary Results in Pediatric Hepato-Gastrointestinal Disorders. Eur J Pediatr Surg. 2017 Feb;27(1):20-25. doi: 10.1055/s-0036-1593381. Epub 2016 Oct 3.
PMID: 27699732
responsible party type: Principal Investigator
investigator affiliation: University of Cadiz
investigator full name: Manuel Rodriguez Huguet
investigator title: Clinical Professor
mesh term: Wounds and Injuries