<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/NCT02971215</url>
  </required_header>
  <id_info>
    <org_study_id>jagHNSP</org_study_id>
    <nct_id>NCT02971215</nct_id>
  </id_info>
  <brief_title>Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy</brief_title>
  <official_title>Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Castilla-La Mancha Health Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General Nuestra Señora del Prado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Castilla-La Mancha</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of high intensity laser therapy in&#xD;
      the treatment of subacromial impingement syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain has a high prevalence in our society, several studies estimate an annual&#xD;
      prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain,&#xD;
      particularly in third place, after the low back pain and neck pain.&#xD;
&#xD;
      Symptoms of pathologies of subacromial space impingement syndrome, where, regardless of&#xD;
      origin, pain is the number one symptom for the patient, which emanates functional impairment&#xD;
      and the impact on quality of life. Because of the need to implement research to assess the&#xD;
      effectiveness of high intensity laser therapy with new studies mayor methodological quality&#xD;
      of obtaining conclusive results, and based on the scientific evidence supporting the&#xD;
      low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we&#xD;
      consider very interesting the realization of this research project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Baseline</time_frame>
    <description>SPADI test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)</time_frame>
    <description>SPADI test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>one month after the end of the protocol treatment</time_frame>
    <description>SPADI test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>three months after the end of the protocol treatment</time_frame>
    <description>SPADI test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constant-Murley Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constant-Murley Score</measure>
    <time_frame>At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)</time_frame>
    <description>Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constant-Murley Score</measure>
    <time_frame>one month after the end of the protocol treatment</time_frame>
    <description>Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constant-Murley Score</measure>
    <time_frame>three months after the end of the protocol treatment</time_frame>
    <description>Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick-Dash Abbreviated</measure>
    <time_frame>Baseline</time_frame>
    <description>Quick- Dash Abbreviated test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick-Dash Abbreviated</measure>
    <time_frame>At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)</time_frame>
    <description>Quick- Dash Abbreviated test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick-Dash Abbreviated</measure>
    <time_frame>one month after the end of the protocol treatment</time_frame>
    <description>Quick- Dash Abbreviated test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick-Dash Abbreviated</measure>
    <time_frame>three months after the end of the protocol treatment</time_frame>
    <description>Quick- Dash Abbreviated test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Painful pressure threshold</measure>
    <time_frame>Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment</time_frame>
    <description>The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Painful pressure threshold after first session</measure>
    <time_frame>First session - 15 minutes after laser or sham treatment.</time_frame>
    <description>The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment</time_frame>
    <description>Visual analogue scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline</time_frame>
    <description>EQ-5D™ is a standardised instrument for use as a measure of health outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Subacromial Impingement</condition>
  <arm_group>
    <arm_group_label>High-intensity laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity laser therapy application through iLux Laser device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham device</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham high-intensity laser therapy application through sham iLux Laser device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iLux Laser</intervention_name>
    <description>Treatment during 15 sessions. It is divided in two phases: 1. 12W. 50 Hz 20% duty cycle. 50 J/cm² in painful zone. 2. 15 W. Burst (10 pulses-900 msec each train) 250 J/cm² in painful zone. Trough the iLux Laser (Mectronic Medicale, Italy)&#xD;
+ Physical Therapy protocol.</description>
    <arm_group_label>High-intensity laser therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham ilux Laser</intervention_name>
    <description>Sham treatment during 15 sessions trough the iLux Laser (Mectronic Medicale, Italy), It is applies the same time than experimental one but with 0 W + Physical Therapy protocol.</description>
    <arm_group_label>Sham device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18 and 75 years old with diagnosis of subacromial impingement&#xD;
             syndrome or any of the pathologies that compose it (tendinosis-tendinitis&#xD;
             supraspinatus and rest of the rotator cuff, subacromial bursitis and tendinitis of the&#xD;
             long head of the biceps).&#xD;
&#xD;
          -  Visual Analogue Scale (VAS) less than or equal to 7.&#xD;
&#xD;
          -  Forward flexion at least of 100º&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Calcific tendinitis&#xD;
&#xD;
          -  Complete rupture of the rotator cuff.&#xD;
&#xD;
          -  Adhesive capsulitis.&#xD;
&#xD;
          -  Clinical history of pathologies that without affecting the shoulder joint refer to&#xD;
             painful shoulder symptoms (cervical root involvement, cervical surgery, cervical&#xD;
             osteoarthritis and neurological pathologies)&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Be receiving physiotherapeutic treatment or have received it previously for this&#xD;
             pathology one month before the start of treatment.&#xD;
&#xD;
          -  Patients with alterations of thermal sensitivity.&#xD;
&#xD;
          -  Derived from the absolute and relative contraindications of Laser Therapy:&#xD;
&#xD;
          -  Photosensitive patients&#xD;
&#xD;
          -  Neoplastic processes&#xD;
&#xD;
          -  Hyperthyroidism&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients with a history of epileptic seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Aceituno-Gomez, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Castilla-La Mancha Health Service</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Nuestra Señora del Prado</name>
      <address>
        <city>Talavera de la Reina</city>
        <state>Toledo</state>
        <zip>45600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</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/NCT02971215
org study id: jagHNSP
nct id: NCT02971215
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess the effectiveness of high intensity laser therapy in
      the treatment of subacromial impingement syndrome.
Shoulder pain has a high prevalence in our society, several studies estimate an annual
      prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain,
      particularly in third place, after the low back pain and neck pain.

      Symptoms of pathologies of subacromial space impingement syndrome, where, regardless of
      origin, pain is the number one symptom for the patient, which emanates functional impairment
      and the impact on quality of life. Because of the need to implement research to assess the
      effectiveness of high intensity laser therapy with new studies mayor methodological quality
      of obtaining conclusive results, and based on the scientific evidence supporting the
      low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we
      consider very interesting the realization of this research project.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Shoulder Pain and Disability Index (SPADI)
time frame: Baseline
description: SPADI test
measure: Shoulder Pain and Disability Index (SPADI)
time frame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
description: SPADI test
measure: Shoulder Pain and Disability Index (SPADI)
time frame: one month after the end of the protocol treatment
description: SPADI test
measure: Shoulder Pain and Disability Index (SPADI)
time frame: three months after the end of the protocol treatment
description: SPADI test
measure: Constant-Murley Score
time frame: Baseline
description: Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
measure: Constant-Murley Score
time frame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
description: Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
measure: Constant-Murley Score
time frame: one month after the end of the protocol treatment
description: Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
measure: Constant-Murley Score
time frame: three months after the end of the protocol treatment
description: Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
measure: Quick-Dash Abbreviated
time frame: Baseline
description: Quick- Dash Abbreviated test
measure: Quick-Dash Abbreviated
time frame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
description: Quick- Dash Abbreviated test
measure: Quick-Dash Abbreviated
time frame: one month after the end of the protocol treatment
description: Quick- Dash Abbreviated test
measure: Quick-Dash Abbreviated
time frame: three months after the end of the protocol treatment
description: Quick- Dash Abbreviated test
measure: Painful pressure threshold
time frame: Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment
description: The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
measure: Painful pressure threshold after first session
time frame: First session - 15 minutes after laser or sham treatment.
description: The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
measure: VAS
time frame: Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment
description: Visual analogue scale
measure: Quality of life
time frame: Baseline
description: EQ-5D™ is a standardised instrument for use as a measure of health outcome.
arm group label: High-intensity laser therapy
arm group type: Experimental
description: High-intensity laser therapy application through iLux Laser device
arm group label: Sham device
arm group type: Sham Comparator
description: Sham high-intensity laser therapy application through sham iLux Laser device
intervention type: Device
intervention name: iLux Laser
description: Treatment during 15 sessions. It is divided in two phases: 1. 12W. 50 Hz 20% duty cycle. 50 J/cm² in painful zone. 2. 15 W. Burst (10 pulses-900 msec each train) 250 J/cm² in painful zone. Trough the iLux Laser (Mectronic Medicale, Italy)
+ Physical Therapy protocol.
arm group label: High-intensity laser therapy
intervention type: Device
intervention name: Sham ilux Laser
description: Sham treatment during 15 sessions trough the iLux Laser (Mectronic Medicale, Italy), It is applies the same time than experimental one but with 0 W + Physical Therapy protocol.
arm group label: Sham device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Javier Aceituno-Gomez, PT
role: Principal Investigator
affiliation: Castilla-La Mancha Health Service
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Shoulder Impingement Syndrome