<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/NCT03816826</url>
  </required_header>
  <id_info>
    <org_study_id>1609MPHILSMMPT002</org_study_id>
    <nct_id>NCT03816826</nct_id>
  </id_info>
  <brief_title>&quot;THE EFFECTS OF LOW LEVEL LASER THERAPY VERSUS STRAIN/COUNTER STRAIN TECHNIQUE IN ACUTE SOFT TISSUE INJURIES&quot;</brief_title>
  <official_title>&quot;THE EFFECTS OF LOW LEVEL LASER THERAPY VERSUS STRAIN/COUNTER STRAIN TECHNIQUE IN ACUTE SOFT TISSUE INJURIES&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isra University</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>
      Muscle strain injuries are common in sports but are often misdiagnosed and maltreated.&#xD;
&#xD;
      Their significance is often underestimated because most athletes can continue their daily&#xD;
      activities soon after the injury. Proximal hamstrings strains have attracted greater&#xD;
      attention because they have a high incidence which is approximately 42%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      it will be randomized control trial with 60 patients with Acute hamstring Injuries divided&#xD;
      into 3 groups. One group will be given Laser therapy, 2nd will be given Strain/Counter Strain&#xD;
      technique and 3rd will be given both the techniques in combination This study will be&#xD;
      conducted in Rehabilitation setup of Pakistan Hockey Federation Lahore, and Institute of&#xD;
      Orthopedics and Rehabilitation Center Garden Town Lahore. Non probability Convenience&#xD;
      Sampling technique will be utilized&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 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>Sequential Assignment</intervention_model>
    <intervention_model_description>60 athletes with hamstring injury distributed randomly into 3 group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analogue scale</measure>
    <time_frame>5 days</time_frame>
    <description>to measure pain scale will be used consisting of digits from 0 to 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FASH questionaire</measure>
    <time_frame>5 days</time_frame>
    <description>hamstring injury and funtional capacity of hamstring</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hamstring Injury</condition>
  <condition>Strain Counter Strain</condition>
  <arm_group>
    <arm_group_label>laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>athletes with acute soft tissue injuries will be recruited in the study , patients will be treated using the the laser therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>strain/counter strain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>athletes with acute soft tissue injuries will be treated with with strain counter strain technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combination therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combination of laser therapy along with strain counter strain technique to visualize the effect the</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical therapy</intervention_name>
    <description>both are physical therapy intervention technique used to treat the soft tissue acute injuries</description>
    <arm_group_label>combination therapy</arm_group_label>
    <arm_group_label>laser</arm_group_label>
    <arm_group_label>strain/counter strain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        hamstring injury patient with grade 2 or 1 both male and female local tenderness on&#xD;
        palpation pain with resisted knee flexion pain with resisted hip extension pain on&#xD;
        stretching of effected area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with fracture&#xD;
&#xD;
          -  patient with grade 3 orthopedic condition like ankylosing spondylitis medically&#xD;
             unstable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>32 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr Adnan</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>44950</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</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>Wounds and Injuries</mesh_term>
    <mesh_term>Sprains and Strains</mesh_term>
    <mesh_term>Soft Tissue Injuries</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/NCT03816826
org study id: 1609MPHILSMMPT002
nct id: NCT03816826
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Muscle strain injuries are common in sports but are often misdiagnosed and maltreated.

      Their significance is often underestimated because most athletes can continue their daily
      activities soon after the injury. Proximal hamstrings strains have attracted greater
      attention because they have a high incidence which is approximately 42%.
it will be randomized control trial with 60 patients with Acute hamstring Injuries divided
      into 3 groups. One group will be given Laser therapy, 2nd will be given Strain/Counter Strain
      technique and 3rd will be given both the techniques in combination This study will be
      conducted in Rehabilitation setup of Pakistan Hockey Federation Lahore, and Institute of
      Orthopedics and Rehabilitation Center Garden Town Lahore. Non probability Convenience
      Sampling technique will be utilized
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: 60 athletes with hamstring injury distributed randomly into 3 group
primary purpose: Treatment
masking: Single (Investigator)
measure: visual analogue scale
time frame: 5 days
description: to measure pain scale will be used consisting of digits from 0 to 10
measure: FASH questionaire
time frame: 5 days
description: hamstring injury and funtional capacity of hamstring
arm group label: laser
arm group type: Experimental
description: athletes with acute soft tissue injuries will be recruited in the study , patients will be treated using the the laser therapy
arm group label: strain/counter strain
arm group type: Experimental
description: athletes with acute soft tissue injuries will be treated with with strain counter strain technique
arm group label: combination therapy
arm group type: Experimental
description: combination of laser therapy along with strain counter strain technique to visualize the effect the
intervention type: Other
intervention name: physical therapy
description: both are physical therapy intervention technique used to treat the soft tissue acute injuries
arm group label: combination therapy
arm group label: laser
arm group label: strain/counter strain
criteria: 
gender: All
minimum age: 16 Years
maximum age: 32 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Sprains and Strains
mesh term: Soft Tissue Injuries
sharing ipd: No