<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/NCT04445545</url>
  </required_header>
  <id_info>
    <org_study_id>60312070</org_study_id>
    <nct_id>NCT04445545</nct_id>
  </id_info>
  <brief_title>High Intensity Laser Therapy (HILT) on Myofascial Trigger Points.</brief_title>
  <acronym>HILT</acronym>
  <official_title>Effectiveness of High Intensity Laser Therapy (HILT) and Stretching Exercises on Cervical Flexibility and Pain Reduction in Myofascial Trigger Points. Randomized Clinical Trial (RCT).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quiropraxia y Equilibrio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Quiropraxia y Equilibrio</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>
      The aim of the study is to evaluate the effects of HILT on cervical flexibility and pain&#xD;
      reduction in myofascial trigger points. The research will be carried out in the Physiotherapy&#xD;
      laboratory of Andrés Bello University. The participants will be civil servants and volunteer&#xD;
      university students with the presence of latent MTrPs of the upper trapezius muscle.&#xD;
      Participants will be randomized and divided into 3 study groups: group 1 (HILT and stretching&#xD;
      exercises), group 2 (sham HILT and stretching exercises), and group 3 (the conventional US&#xD;
      and stretching exercises). The treatments will be carried out twice a week for 4 weeks&#xD;
      accompanied by 2 evaluations during the treatment and 1 post-treatment follow-up. The main&#xD;
      result will be considered the differences in pain intensity (ΔPI), pain pressure threshold&#xD;
      (ΔPPT), cervical spine range (ΔCROM), and cervical disability (ΔND) between the evaluation&#xD;
      sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material and Methods&#xD;
&#xD;
      Type of study: Experimental, randomized clinical trial (RCT).&#xD;
&#xD;
      1. Study population.&#xD;
&#xD;
      For the study, students and workers of Andrés Bello University will be considered&#xD;
      participants.&#xD;
&#xD;
      2 Randomization and sample.&#xD;
&#xD;
      Participants will be evaluated according to the selection criteria through a survey with&#xD;
      closed questions and a clinical examination in which the presence or absence of shortening of&#xD;
      upper trapezius muscle shortening will be determined and the presence of a myofascial trigger&#xD;
      point (MTrPs) in the muscle. The participants will be chosen according to the selection&#xD;
      criteria through a survey with closed questions and a clinical examination in which the&#xD;
      presence of muscle shortening of the upper trapezius and the presence of myofascial trigger&#xD;
      point in the said muscle. Participants will be divided into three study groups through a&#xD;
      simple randomization process; group 1 (HILT), group 2 (sham HILT), and group 3 (HILT). the&#xD;
      conventional US). All groups will receive as a basic treatment a therapeutic exercise plan of&#xD;
      active static stretching of the upper trapezius muscle of 4 series for 30 seconds.&#xD;
      Participants will be scheduled twice a week for four weeks to carry out the assigned&#xD;
      treatment.&#xD;
&#xD;
      The sample size will be determined with the G-Power program using a power of 0.85 (1-β),&#xD;
      reliability of 95%, an error of 5% (α), and an effect size of d=0.75 (d-Cohen) taking as&#xD;
      reference previous studies that have determined the differences in the PPT mean in MTrPs&#xD;
      between experimental groups and controls after treatment with HILT.35,49 Based on the above,&#xD;
      the sample size is 24 subjects with 8 subjects per group.&#xD;
&#xD;
      3. Procedures&#xD;
&#xD;
      Participants in each group will be evaluated by two independent examiners to determine&#xD;
      cervical spine flexibility (CFROM) and pain intensity (PI), considered the main outcome&#xD;
      measures of the study. The range of motion will be measured through goniometry, and pain&#xD;
      intensity will be evaluated through algometry, establishing the painful pressure threshold&#xD;
      (PPT). The PPT values will be evaluated in kg/cm2, while the CFROM will be evaluated in&#xD;
      degrees. The PI and CFROM values will be tabulated in an Excel® spreadsheet for each&#xD;
      evaluator.&#xD;
&#xD;
      The evaluations will be carried out during the study in 3 instances (T0-T2) including later 1&#xD;
      follow-up evaluation (T3): pretreatment (T0: baseline), second week (T1: 4th session), fourth&#xD;
      week (T2: 8th session). ) and fifth week (T3: follow-up). The participants will be summoned&#xD;
      twice a week to carry out their corresponding treatments. On the other hand, cervical&#xD;
      disability will be evaluated using the cervical disability index (NDI), obtaining the&#xD;
      percentage of disability for each of the evaluation instances. On the other hand, the NDI&#xD;
      will be applied as a self-report before and after the treatment sessions (T0 and T2).&#xD;
&#xD;
      Once the study is over, the differences in cervical range of motion (ΔCFROM), pain pressure&#xD;
      threshold (ΔPPT), pain intensity (ΔPI), and cervical disability (ΔNDI) between the evaluation&#xD;
      sessions will be evaluated.&#xD;
&#xD;
      4. Variables&#xD;
&#xD;
      4.1 Conceptual definition of the variables.&#xD;
&#xD;
        -  Cervical flexibility (CFROM): physical capacity responsible for the voluntary execution&#xD;
           of the maximum joint movement of the cervical spine. The CFROM examination will be&#xD;
           performed by the participant in a seated position keeping their back straight and&#xD;
           supported by a backrest.&#xD;
&#xD;
        -  Pain intensity (PI): magnitude of pain reported by the participants after performing the&#xD;
           myofascial trigger point (MTrP) algometry test in the shortened upper trapezius muscle&#xD;
           after performing the test. The test of the PI will be performed by the participant in a&#xD;
           seated position keeping their back straight and supported by a backrest.&#xD;
&#xD;
        -  Painful pressure threshold (PPT): magnitude of pressure referred to as painful by the&#xD;
           participant when performing the algometry test on the myofascial trigger point (MTrP) of&#xD;
           the shortened upper trapezius muscle. The PPT exam will be performed by the participant&#xD;
           in a seated position keeping their back straight and supported by a backrest.&#xD;
&#xD;
        -  Cervical disability (ND): level of cervical condition reported by the participants that&#xD;
           compromise or may compromise the normal development of their activities of daily living.&#xD;
&#xD;
        -  High-Intensity Laser Therapy (HILT): laser application with powers greater than 500&#xD;
           milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius.&#xD;
&#xD;
        -  Conventional ultrasound (US): application of ultrasound therapy in the myofascial&#xD;
           trigger point of the upper trapezius muscle.&#xD;
&#xD;
        -  Stretching exercise (SE): active static stretching for the upper trapezius muscle with&#xD;
           the presence of myofascial trigger points (positive MTrPs).26,40,41&#xD;
&#xD;
      4.2 Operational definition of variables.&#xD;
&#xD;
        -  Cervical flexibility (CFROM): The maximum cervical ranges of motion (CFROM) will be&#xD;
           evaluated through an inclinometer (CROM device), recording the degrees of movement for&#xD;
           the coronal, sagittal and horizontal planes (Inter-rater reliability: Extension ICC =&#xD;
           0.98 ( 95% CI 0.95, 0.99); Flexion ICC = 0.89 (95% CI 0.73, 0.96); Left Rotation ICC =&#xD;
           0.95 (95% CI 0.87, 0.98); Right Rotation ICC = 0.92 (95% CI 0.80, 0.97); Tilt left ICC =&#xD;
           0.97 (95% CI 0.91, 0.99), right slope ICC = 0.97 (95% CI 0.93, 0.99).&#xD;
&#xD;
        -  Painful pressure threshold (PPT): the painful pressure threshold (PPT) will be&#xD;
           quantified by algometry, recording the pressure values in kg/cm2 that generate pain in&#xD;
           the MTrPs of the upper trapezius muscle (intra-rater reliability: ICC = 0.92-0.98 (CI&#xD;
           not reported; inter-rater reliability: ICC = 0.92 (95% CI 0.85,0.97).) The Baseline®&#xD;
           brand pressure algometer will be used for the evaluation.&#xD;
&#xD;
        -  Cervical Disability (ND): Cervical disability will be evaluated through the Cervical&#xD;
           Disability Index (NDI), an instrument that consists of 10 sections with questions&#xD;
           related to symptoms and activities of daily living in which the cervical region is&#xD;
           involved. Each section costs questions scored from 0-5, with greater disability being&#xD;
           linked to a higher score (inter-rater reliability: ICC = 0.93 (95% CI 0.86, 0.97)).&#xD;
&#xD;
        -  High-Intensity Laser Therapy (HILT): High-intensity laser therapy (HILT) will be applied&#xD;
           to the upper trapezius muscle using the protocol of the study by Dundar et al.48 A total&#xD;
           energy delivery of 1,060J divided into 3 phases will be achieved. (phase 1, 500J; phase&#xD;
           2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density&#xD;
           of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment will be&#xD;
           used, which emits infrared wavelengths of 1064nm (ANNEX 7).&#xD;
&#xD;
        -  Conventional ultrasound (US): the application of ultrasound will be performed with the&#xD;
           person in a seated position. The ultrasound parameters will consist of a frequency of&#xD;
           1MHz, the intensity of 1.5 W/cm2, a Duty cycle of 100%, an ERA of 5cm2, and a treatment&#xD;
           time of 6 minutes.32 The application of US will be carried out using the COMBI 500&#xD;
           equipment of the company GYMNA®.&#xD;
&#xD;
        -  Stretching exercise (SE): 4 sets of active static stretching of the upper trapezius&#xD;
           muscle will be performed. Each series will last 30 seconds followed by a rest interval&#xD;
           of 30 seconds.&#xD;
&#xD;
      4.3 Variable type definition&#xD;
&#xD;
        -  Cervical flexibility (CFROM): dependent, quantitative, discrete variable.&#xD;
&#xD;
        -  Pain intensity (PI): dependent, quantitative, discrete variable.&#xD;
&#xD;
        -  Painful pressure threshold (PPT): dependent, quantitative, discrete variable.&#xD;
&#xD;
        -  Cervical disability (ND): dependent variable, quantitative, continuous.&#xD;
&#xD;
        -  High-Intensity Laser Therapy (HILT): independent, quantitative, continuous variable.&#xD;
&#xD;
        -  Conventional ultrasound (US): independent, quantitative, continuous variable.&#xD;
&#xD;
        -  Stretching exercise (EE): independent, quantitative, discrete variable.&#xD;
&#xD;
           5. Study phases&#xD;
&#xD;
      Three phases have been designated for the investigation; 1. Sampling phase, 2. Evaluation&#xD;
      phase and 3. Intervention phase.&#xD;
&#xD;
      The sampling phase will consist of the application of the selection survey to all students&#xD;
      and officials interested in participating in the study. The survey will be applied to them&#xD;
      through the Google Drive® system. All those who meet the selection criteria will be invited&#xD;
      to participate in the research. This stage will last two weeks.&#xD;
&#xD;
      The evaluation phase will determine a second filter of the population and will include the&#xD;
      participants selected by the selection survey who expressed their consent in writing. At this&#xD;
      stage, a clinical examination will be performed to determine the presence of shortening of&#xD;
      the upper trapezius muscle and myofascial trigger points. The evaluation of the length of the&#xD;
      upper trapezius will be carried out by means of an evaluation of the cervical tilt range,&#xD;
      while the assessment of the MTrPs will be carried out next in the upper trapezius muscle&#xD;
      using the criteria established in the study by Delphi et al. (expert agreement for the&#xD;
      diagnosis of MTrPs), in which at least two of the following criteria must be present: 1. taut&#xD;
      band, 2. hypersensitive point and 3. pain referred to the compression of the point.24,25 It&#xD;
      will be considered as shortened upper trapezius, that muscle contralateral to the lowest&#xD;
      degree of cervical inclination measured with an inclinometer. In the event that both&#xD;
      trapezius muscles present the same value in degrees, the one that the participant refers to&#xD;
      with greater tension will be considered as shortening. The MTrPs examination will be&#xD;
      performed by drawing a line between the spinous process of C7 and the midpoint of the upper&#xD;
      border of the ipsilateral acromion next to the trapezius evaluated as short, palpating from&#xD;
      medial to lateral in search of a point that meets the criteria. exposed. In cases where more&#xD;
      than 1 MTrP was located along the reference line, the most sensitive or painful point will be&#xD;
      used as a reference. Participants with a negative (-) physical examination, that is, without&#xD;
      the presence of MTrPs in the trapezius muscle shortened according to the protocol will be&#xD;
      excluded, while those with a positive physical examination (+) will be able to participate in&#xD;
      the study. The evaluation of muscle shortening and the presence of MTrPs will be carried out&#xD;
      by a blind evaluator, who will record the laterality of the shortened muscle and the location&#xD;
      distance of the MTrPs in a Microsoft Excel® spreadsheet, taking the spinous process of C7 as&#xD;
      a reference.&#xD;
&#xD;
      The intervention phase will consist of 8 treatment sessions. The sample will be randomized&#xD;
      into three study groups; group 1 (HILT + stretching exercises), group 2 (sham HILT +&#xD;
      stretching exercises), and group 3 (conventional US + stretching exercises). All groups will&#xD;
      receive as a basic treatment a therapeutic exercise plan of active static stretching of the&#xD;
      upper trapezius muscle of 4 series for 30 seconds. The randomization of the sample will be&#xD;
      carried out by the director of the study using the simple random sampling process through the&#xD;
      research randomizer program (https://www.randomizer.org/). The results of the randomization&#xD;
      will only be known by the director of the studio. Demographic variables for each group,&#xD;
      including age, sex, and body mass index (BMI), will be tabulated in a Microsoft Excel®&#xD;
      program spreadsheet.&#xD;
&#xD;
      Participants in each group will be evaluated by two independent examiners to determine&#xD;
      cervical spine flexibility (CFROM) and pain intensity (PI), considered the main outcome&#xD;
      measures of the study. The range of motion will be measured through goniometry, and the&#xD;
      intensity of pain will be evaluated through algometry, establishing the painful pressure&#xD;
      threshold (PPT). The PPT values will be evaluated in kg/cm2, while the CFROM will be&#xD;
      evaluated in degrees. The PI and CFROM values will be tabulated in an Excel® spreadsheet for&#xD;
      each evaluator.&#xD;
&#xD;
      6. Statistic analysis&#xD;
&#xD;
      The descriptive statistics for the primary variables ΔCFROM, ΔPPT, and ΔNDI will use as&#xD;
      analysis measures, means, and standard deviation (x, SD), or median and interquartile range&#xD;
      (med, IQR) according to the normality analysis of the data. For secondary variables such as&#xD;
      gender, body mass index (BMI), frequencies, and means or medians will be used, respectively,&#xD;
      according to the normality analysis of the data.&#xD;
&#xD;
      For the inferential statistical analysis, the Shapiro Wilk (S-Wilk) normality test will be&#xD;
      used to determine the distribution of the primary variables, and according to the results,&#xD;
      parametric or non-parametric tests will be selected; One-way ANOVA if data are normally&#xD;
      distributed or Kruskal Wallis test if variables are not normally distributed. For the&#xD;
      statistical analysis, the STATA.v16 program will be used. Once the statistical analysis is&#xD;
      done, a month will be considered for the review of the results, approach to the discussion,&#xD;
      and conclusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 1, 2023</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain pressure thereshold (PPT)</measure>
    <time_frame>Change from Baseline pain pressure thereshold at eight treatment sessions.</time_frame>
    <description>Comparing pain pressure threshold differences on trigger point of trapezius muscle for pre and post-treatment protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Joint Range changes (CFROM)</measure>
    <time_frame>Change from Baseline joint range changes at eight treatment sessions.</time_frame>
    <description>Comparing maximum cervical range differences for pre and post for pre and post-treatment protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neck disability</measure>
    <time_frame>Change from Baseline meck disability at eight treatment sessions.</time_frame>
    <description>Comparing neck disability for pre and post treatment protocol.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Myofascial Trigger Point Pain (MTrP)</condition>
  <arm_group>
    <arm_group_label>Experimental group 1 (HILT + stretching exercise)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group will receive treatment of high-intensity laser therapy (HILT) with a total energy delivery of 1,060J divided into 3 phases will be achieved: phase 1, 500J; phase 2, 60J; phase 3, 500J. It will work with an average power of 3W and an energy density of 50J/cm2. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group 2 (Sham HILT + stretching exercise)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The group will receive a sham treatment of high-intensity laser therapy (HILT). At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group 3 (US + stretching exercise)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group will receive treatment of therapeutic ultrasound. The US parameters will be programmed with a frequency of 1MHz, the intensity of 1.5 W/cm2, the Duty cycle of 100%, an ERA of 5cm2, and a time of 6 minutes. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High intensity laser therapy (HILT)</intervention_name>
    <description>Laser application with powers greater than 500 milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius. Laser therapy will be applied to the upper trapezius muscle with a total energy delivery of 1,060J divided into 3 phases will be achieved (phase 1, 500J; phase 2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment that emits infrared wavelengths of 1064nm will be used.</description>
    <arm_group_label>Experimental group 1 (HILT + stretching exercise)</arm_group_label>
    <arm_group_label>Experimental group 2 (Sham HILT + stretching exercise)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therapeutic Ultrasound (US)</intervention_name>
    <description>Application of ultrasound therapy in the myofascial trigger point of the upper trapezius muscle. The ultrasound application will be performed with the person in a seated position. The ultrasound parameters will consist of a frequency of 1MHz, the intensity of 1.5 W/cm2, a Duty cycle of 100%, an ERA of 5cm2, and a treatment time of 6 minutes.</description>
    <arm_group_label>Experimental group 3 (US + stretching exercise)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stretching exercise</intervention_name>
    <description>t the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series</description>
    <arm_group_label>Experimental group 1 (HILT + stretching exercise)</arm_group_label>
    <arm_group_label>Experimental group 2 (Sham HILT + stretching exercise)</arm_group_label>
    <arm_group_label>Experimental group 3 (US + stretching exercise)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants over 18 years of age.&#xD;
&#xD;
          -  Officials and students of the Casona las Condes Campus of the Andrés Bello University.&#xD;
&#xD;
          -  Presence of myofascial trigger points in the shortened upper trapezius muscle&#xD;
             evaluated (expert consensus establishing criteria for the diagnosis of MTrPs, Delphi&#xD;
             study).25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal problems or pathologies of the neck or shoulders in the last 3 months&#xD;
             (fractures, sprains, tendinopathies, dislocations, or muscle tears).&#xD;
&#xD;
          -  Presence of osteosynthesis materials near shoulders, neck, or surrounding areas.&#xD;
&#xD;
          -  Presence of wounds or skin changes in the shoulder and/or neck region (such as&#xD;
             psoriasis, scars, or burns).&#xD;
&#xD;
          -  Use of analgesic, anti-inflammatory, or muscle relaxant medications for permanent use.&#xD;
&#xD;
          -  Neurological changes such as paresthesia, loss of sensitivity (partial or complete),&#xD;
             decreased strength, and color changes in the neck, arms, forearms, or hands.&#xD;
&#xD;
          -  Diagnosed photosensitivity.&#xD;
&#xD;
          -  Presence of solar urticaria or adverse reactions to sunlight.&#xD;
&#xD;
          -  Presence of the following conditions: dermatomyositis, systemic lupus erythematosus,&#xD;
             hepatic porphyria, cutaneous carcinoid syndrome or pellagra&#xD;
&#xD;
          -  Cancer or tumors of any type diagnosed.&#xD;
&#xD;
          -  Epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hernán A de la Barra Ortiz, Mg</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Andrés Bello</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hernán A De la Barra Ortiz, Mg.</last_name>
    <phone>984706322</phone>
    <phone_ext>+56</phone_ext>
    <email>hdelabarra@unab.cl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad Andrés Bello</name>
      <address>
        <city>Santiago de Chile</city>
        <state>Las Condes</state>
        <zip>7591538</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Andrés Bello</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitana</state>
        <zip>7591538</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <link>
    <url>https://www.btlnet.es.</url>
    <description>BTL Company</description>
  </link>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 25, 2023</last_update_submitted>
  <last_update_submitted_qc>March 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lasers</keyword>
  <keyword>Laser Therapy</keyword>
  <keyword>Trigger Points</keyword>
  <keyword>Myofascial Pain Syndromes</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <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/NCT04445545
org study id: 60312070
nct id: NCT04445545
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the effects of HILT on cervical flexibility and pain
      reduction in myofascial trigger points. The research will be carried out in the Physiotherapy
      laboratory of Andrés Bello University. The participants will be civil servants and volunteer
      university students with the presence of latent MTrPs of the upper trapezius muscle.
      Participants will be randomized and divided into 3 study groups: group 1 (HILT and stretching
      exercises), group 2 (sham HILT and stretching exercises), and group 3 (the conventional US
      and stretching exercises). The treatments will be carried out twice a week for 4 weeks
      accompanied by 2 evaluations during the treatment and 1 post-treatment follow-up. The main
      result will be considered the differences in pain intensity (ΔPI), pain pressure threshold
      (ΔPPT), cervical spine range (ΔCROM), and cervical disability (ΔND) between the evaluation
      sessions.
Material and Methods

      Type of study: Experimental, randomized clinical trial (RCT).

      1. Study population.

      For the study, students and workers of Andrés Bello University will be considered
      participants.

      2 Randomization and sample.

      Participants will be evaluated according to the selection criteria through a survey with
      closed questions and a clinical examination in which the presence or absence of shortening of
      upper trapezius muscle shortening will be determined and the presence of a myofascial trigger
      point (MTrPs) in the muscle. The participants will be chosen according to the selection
      criteria through a survey with closed questions and a clinical examination in which the
      presence of muscle shortening of the upper trapezius and the presence of myofascial trigger
      point in the said muscle. Participants will be divided into three study groups through a
      simple randomization process; group 1 (HILT), group 2 (sham HILT), and group 3 (HILT). the
      conventional US). All groups will receive as a basic treatment a therapeutic exercise plan of
      active static stretching of the upper trapezius muscle of 4 series for 30 seconds.
      Participants will be scheduled twice a week for four weeks to carry out the assigned
      treatment.

      The sample size will be determined with the G-Power program using a power of 0.85 (1-β),
      reliability of 95%, an error of 5% (α), and an effect size of d=0.75 (d-Cohen) taking as
      reference previous studies that have determined the differences in the PPT mean in MTrPs
      between experimental groups and controls after treatment with HILT.35,49 Based on the above,
      the sample size is 24 subjects with 8 subjects per group.

      3. Procedures

      Participants in each group will be evaluated by two independent examiners to determine
      cervical spine flexibility (CFROM) and pain intensity (PI), considered the main outcome
      measures of the study. The range of motion will be measured through goniometry, and pain
      intensity will be evaluated through algometry, establishing the painful pressure threshold
      (PPT). The PPT values will be evaluated in kg/cm2, while the CFROM will be evaluated in
      degrees. The PI and CFROM values will be tabulated in an Excel® spreadsheet for each
      evaluator.

      The evaluations will be carried out during the study in 3 instances (T0-T2) including later 1
      follow-up evaluation (T3): pretreatment (T0: baseline), second week (T1: 4th session), fourth
      week (T2: 8th session). ) and fifth week (T3: follow-up). The participants will be summoned
      twice a week to carry out their corresponding treatments. On the other hand, cervical
      disability will be evaluated using the cervical disability index (NDI), obtaining the
      percentage of disability for each of the evaluation instances. On the other hand, the NDI
      will be applied as a self-report before and after the treatment sessions (T0 and T2).

      Once the study is over, the differences in cervical range of motion (ΔCFROM), pain pressure
      threshold (ΔPPT), pain intensity (ΔPI), and cervical disability (ΔNDI) between the evaluation
      sessions will be evaluated.

      4. Variables

      4.1 Conceptual definition of the variables.

        -  Cervical flexibility (CFROM): physical capacity responsible for the voluntary execution
           of the maximum joint movement of the cervical spine. The CFROM examination will be
           performed by the participant in a seated position keeping their back straight and
           supported by a backrest.

        -  Pain intensity (PI): magnitude of pain reported by the participants after performing the
           myofascial trigger point (MTrP) algometry test in the shortened upper trapezius muscle
           after performing the test. The test of the PI will be performed by the participant in a
           seated position keeping their back straight and supported by a backrest.

        -  Painful pressure threshold (PPT): magnitude of pressure referred to as painful by the
           participant when performing the algometry test on the myofascial trigger point (MTrP) of
           the shortened upper trapezius muscle. The PPT exam will be performed by the participant
           in a seated position keeping their back straight and supported by a backrest.

        -  Cervical disability (ND): level of cervical condition reported by the participants that
           compromise or may compromise the normal development of their activities of daily living.

        -  High-Intensity Laser Therapy (HILT): laser application with powers greater than 500
           milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius.

        -  Conventional ultrasound (US): application of ultrasound therapy in the myofascial
           trigger point of the upper trapezius muscle.

        -  Stretching exercise (SE): active static stretching for the upper trapezius muscle with
           the presence of myofascial trigger points (positive MTrPs).26,40,41

      4.2 Operational definition of variables.

        -  Cervical flexibility (CFROM): The maximum cervical ranges of motion (CFROM) will be
           evaluated through an inclinometer (CROM device), recording the degrees of movement for
           the coronal, sagittal and horizontal planes (Inter-rater reliability: Extension ICC =
           0.98 ( 95% CI 0.95, 0.99); Flexion ICC = 0.89 (95% CI 0.73, 0.96); Left Rotation ICC =
           0.95 (95% CI 0.87, 0.98); Right Rotation ICC = 0.92 (95% CI 0.80, 0.97); Tilt left ICC =
           0.97 (95% CI 0.91, 0.99), right slope ICC = 0.97 (95% CI 0.93, 0.99).

        -  Painful pressure threshold (PPT): the painful pressure threshold (PPT) will be
           quantified by algometry, recording the pressure values in kg/cm2 that generate pain in
           the MTrPs of the upper trapezius muscle (intra-rater reliability: ICC = 0.92-0.98 (CI
           not reported; inter-rater reliability: ICC = 0.92 (95% CI 0.85,0.97).) The Baseline®
           brand pressure algometer will be used for the evaluation.

        -  Cervical Disability (ND): Cervical disability will be evaluated through the Cervical
           Disability Index (NDI), an instrument that consists of 10 sections with questions
           related to symptoms and activities of daily living in which the cervical region is
           involved. Each section costs questions scored from 0-5, with greater disability being
           linked to a higher score (inter-rater reliability: ICC = 0.93 (95% CI 0.86, 0.97)).

        -  High-Intensity Laser Therapy (HILT): High-intensity laser therapy (HILT) will be applied
           to the upper trapezius muscle using the protocol of the study by Dundar et al.48 A total
           energy delivery of 1,060J divided into 3 phases will be achieved. (phase 1, 500J; phase
           2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density
           of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment will be
           used, which emits infrared wavelengths of 1064nm (ANNEX 7).

        -  Conventional ultrasound (US): the application of ultrasound will be performed with the
           person in a seated position. The ultrasound parameters will consist of a frequency of
           1MHz, the intensity of 1.5 W/cm2, a Duty cycle of 100%, an ERA of 5cm2, and a treatment
           time of 6 minutes.32 The application of US will be carried out using the COMBI 500
           equipment of the company GYMNA®.

        -  Stretching exercise (SE): 4 sets of active static stretching of the upper trapezius
           muscle will be performed. Each series will last 30 seconds followed by a rest interval
           of 30 seconds.

      4.3 Variable type definition

        -  Cervical flexibility (CFROM): dependent, quantitative, discrete variable.

        -  Pain intensity (PI): dependent, quantitative, discrete variable.

        -  Painful pressure threshold (PPT): dependent, quantitative, discrete variable.

        -  Cervical disability (ND): dependent variable, quantitative, continuous.

        -  High-Intensity Laser Therapy (HILT): independent, quantitative, continuous variable.

        -  Conventional ultrasound (US): independent, quantitative, continuous variable.

        -  Stretching exercise (EE): independent, quantitative, discrete variable.

           5. Study phases

      Three phases have been designated for the investigation; 1. Sampling phase, 2. Evaluation
      phase and 3. Intervention phase.

      The sampling phase will consist of the application of the selection survey to all students
      and officials interested in participating in the study. The survey will be applied to them
      through the Google Drive® system. All those who meet the selection criteria will be invited
      to participate in the research. This stage will last two weeks.

      The evaluation phase will determine a second filter of the population and will include the
      participants selected by the selection survey who expressed their consent in writing. At this
      stage, a clinical examination will be performed to determine the presence of shortening of
      the upper trapezius muscle and myofascial trigger points. The evaluation of the length of the
      upper trapezius will be carried out by means of an evaluation of the cervical tilt range,
      while the assessment of the MTrPs will be carried out next in the upper trapezius muscle
      using the criteria established in the study by Delphi et al. (expert agreement for the
      diagnosis of MTrPs), in which at least two of the following criteria must be present: 1. taut
      band, 2. hypersensitive point and 3. pain referred to the compression of the point.24,25 It
      will be considered as shortened upper trapezius, that muscle contralateral to the lowest
      degree of cervical inclination measured with an inclinometer. In the event that both
      trapezius muscles present the same value in degrees, the one that the participant refers to
      with greater tension will be considered as shortening. The MTrPs examination will be
      performed by drawing a line between the spinous process of C7 and the midpoint of the upper
      border of the ipsilateral acromion next to the trapezius evaluated as short, palpating from
      medial to lateral in search of a point that meets the criteria. exposed. In cases where more
      than 1 MTrP was located along the reference line, the most sensitive or painful point will be
      used as a reference. Participants with a negative (-) physical examination, that is, without
      the presence of MTrPs in the trapezius muscle shortened according to the protocol will be
      excluded, while those with a positive physical examination (+) will be able to participate in
      the study. The evaluation of muscle shortening and the presence of MTrPs will be carried out
      by a blind evaluator, who will record the laterality of the shortened muscle and the location
      distance of the MTrPs in a Microsoft Excel® spreadsheet, taking the spinous process of C7 as
      a reference.

      The intervention phase will consist of 8 treatment sessions. The sample will be randomized
      into three study groups; group 1 (HILT + stretching exercises), group 2 (sham HILT +
      stretching exercises), and group 3 (conventional US + stretching exercises). All groups will
      receive as a basic treatment a therapeutic exercise plan of active static stretching of the
      upper trapezius muscle of 4 series for 30 seconds. The randomization of the sample will be
      carried out by the director of the study using the simple random sampling process through the
      research randomizer program (https://www.randomizer.org/). The results of the randomization
      will only be known by the director of the studio. Demographic variables for each group,
      including age, sex, and body mass index (BMI), will be tabulated in a Microsoft Excel®
      program spreadsheet.

      Participants in each group will be evaluated by two independent examiners to determine
      cervical spine flexibility (CFROM) and pain intensity (PI), considered the main outcome
      measures of the study. The range of motion will be measured through goniometry, and the
      intensity of pain will be evaluated through algometry, establishing the painful pressure
      threshold (PPT). The PPT values will be evaluated in kg/cm2, while the CFROM will be
      evaluated in degrees. The PI and CFROM values will be tabulated in an Excel® spreadsheet for
      each evaluator.

      6. Statistic analysis

      The descriptive statistics for the primary variables ΔCFROM, ΔPPT, and ΔNDI will use as
      analysis measures, means, and standard deviation (x, SD), or median and interquartile range
      (med, IQR) according to the normality analysis of the data. For secondary variables such as
      gender, body mass index (BMI), frequencies, and means or medians will be used, respectively,
      according to the normality analysis of the data.

      For the inferential statistical analysis, the Shapiro Wilk (S-Wilk) normality test will be
      used to determine the distribution of the primary variables, and according to the results,
      parametric or non-parametric tests will be selected; One-way ANOVA if data are normally
      distributed or Kruskal Wallis test if variables are not normally distributed. For the
      statistical analysis, the STATA.v16 program will be used. Once the statistical analysis is
      done, a month will be considered for the review of the results, approach to the discussion,
      and conclusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Pain pressure thereshold (PPT)
time frame: Change from Baseline pain pressure thereshold at eight treatment sessions.
description: Comparing pain pressure threshold differences on trigger point of trapezius muscle for pre and post-treatment protocol.
measure: Joint Range changes (CFROM)
time frame: Change from Baseline joint range changes at eight treatment sessions.
description: Comparing maximum cervical range differences for pre and post for pre and post-treatment protocol.
measure: Neck disability
time frame: Change from Baseline meck disability at eight treatment sessions.
description: Comparing neck disability for pre and post treatment protocol.
arm group label: Experimental group 1 (HILT + stretching exercise)
arm group type: Experimental
description: The group will receive treatment of high-intensity laser therapy (HILT) with a total energy delivery of 1,060J divided into 3 phases will be achieved: phase 1, 500J; phase 2, 60J; phase 3, 500J. It will work with an average power of 3W and an energy density of 50J/cm2. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
arm group label: Experimental group 2 (Sham HILT + stretching exercise)
arm group type: Sham Comparator
description: The group will receive a sham treatment of high-intensity laser therapy (HILT). At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
arm group label: Experimental group 3 (US + stretching exercise)
arm group type: Active Comparator
description: The group will receive treatment of therapeutic ultrasound. The US parameters will be programmed with a frequency of 1MHz, the intensity of 1.5 W/cm2, the Duty cycle of 100%, an ERA of 5cm2, and a time of 6 minutes. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.
intervention type: Device
intervention name: High intensity laser therapy (HILT)
description: Laser application with powers greater than 500 milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius. Laser therapy will be applied to the upper trapezius muscle with a total energy delivery of 1,060J divided into 3 phases will be achieved (phase 1, 500J; phase 2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment that emits infrared wavelengths of 1064nm will be used.
arm group label: Experimental group 1 (HILT + stretching exercise)
arm group label: Experimental group 2 (Sham HILT + stretching exercise)
intervention type: Device
intervention name: Therapeutic Ultrasound (US)
description: Application of ultrasound therapy in the myofascial trigger point of the upper trapezius muscle. The ultrasound application will be performed with the person in a seated position. The ultrasound parameters will consist of a frequency of 1MHz, the intensity of 1.5 W/cm2, a Duty cycle of 100%, an ERA of 5cm2, and a treatment time of 6 minutes.
arm group label: Experimental group 3 (US + stretching exercise)
intervention type: Procedure
intervention name: Stretching exercise
description: t the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series
arm group label: Experimental group 1 (HILT + stretching exercise)
arm group label: Experimental group 2 (Sham HILT + stretching exercise)
arm group label: Experimental group 3 (US + stretching exercise)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hernán A de la Barra Ortiz, Mg
role: Principal Investigator
affiliation: Universidad Andrés Bello
last name: Hernán A De la Barra Ortiz, Mg.
phone: 984706322
phone ext: +56
email: hdelabarra@unab.cl
facility: 
facility: 
country: Chile
url: https://www.btlnet.es.
description: BTL Company
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citation: Hadis MA, Zainal SA, Holder MJ, Carroll JD, Cooper PR, Milward MR, Palin WM. The dark art of light measurement: accurate radiometry for low-level light therapy. Lasers Med Sci. 2016 May;31(4):789-809. doi: 10.1007/s10103-016-1914-y. Epub 2016 Mar 10.
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citation: Ohshiro T, Ohshiro T, Sasaki K, Kishi K. Picosecond pulse duration laser treatment for dermal melanocytosis in Asians : A retrospective review. Laser Ther. 2016 Jun 29;25(2):99-104. doi: 10.5978/islsm.16-OR-07.
PMID: 27721561
citation: Oh-hama T, Santander PJ, Stolowich NJ, Scott AI. Bacteriochlorophyll c formation via the C5 pathway of 5-aminolevulinic acid synthesis in Chloroflexus aurantiacus. FEBS Lett. 1991 Apr 9;281(1-2):173-6. doi: 10.1016/0014-5793(91)80386-h.
PMID: 2015889
citation: Ferraresi C, Huang YY, Hamblin MR. Photobiomodulation in human muscle tissue: an advantage in sports performance? J Biophotonics. 2016 Dec;9(11-12):1273-1299. doi: 10.1002/jbio.201600176. Epub 2016 Nov 22.
PMID: 27874264
citation: Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.
PMID: 26914684
citation: Stiglic-Rogoznica N, Stamenkovic D, Frlan-Vrgoc L, Avancini-Dobrovic V, Vrbanic TS. Analgesic effect of high intensity laser therapy in knee osteoarthritis. Coll Antropol. 2011 Sep;35 Suppl 2:183-5.
PMID: 22220431
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responsible party type: Sponsor
mesh term: Myofascial Pain Syndromes
sharing ipd: No