<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220922056020N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-24</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Post-isometric relaxation technique in Mechanical low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Post-Isometric Relaxation Technique and Static Stretching of Quadratus Lumborum on Pain and Functional Disability in Patients with Mechanical Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66808</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: non-probability sampling technique will be used to enroll the patients in intervention and control group and concealed envelop will be used for the random allocation.
we prepare opaque envelops which contain slip of paper that indicate the treatment allocation in control and interventional group. Then randomly assign the slip of paper to envelops, ensure concealment of treatment assignment. When participant enroll, they select the envelop randomly and assign the participant to the corresponding treatment without the knowledge of allocation. Then we open the envelop in the presence of participant and reveal the treatment assignment to maintain the transparency. Then repeat the process for subsequent participants and make ensure that the randomization is concealed and unbiased throughout the research, Blinding description: single blinding study with blinding of assessor by labeling the experimental and control groups with unidentifying terms such as symbols or digits.</study_design>
      <phase>2</phase>
      <hc_freetext>Mechanical low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Participants received routine physical therapy which include TENS with Hot pack and exercises for the strengthening of muscles. Hot Moist pack: 10 mins for relaxing soft tissue structures and increase extensibility. Transcutaneous Electrical stimulator:10 mins for pain relief. Exercises: 10 repetitions- 5 sec hold for strengthening the muscles •Side bending •Side bridging•	Pelvic bridging •Cat camel. Intervention 2: Intervention group: Participants received Post-isometric relaxation technique and static stretching with routine physical therapy. Post-isometric relaxation technique: Thirty-nine participants received post-isometric relaxation technique for Quadratus lumborum. Position of the patient is side lying with uppermost arm fully extended. Position of the therapist; behind the patient at waist level. Inhale and abduct the uppermost leg and hold the leg and breathe for 7-10 seconds allowing the gravity to provide resistance. Patient then hang the leg behind him over the back of the table. Release the breath on slowly ceasing contraction. Therapist cradles the pelvis with both hands to take out all slack during exhalation. Hold stretch for 10 seconds. Patient relaxed for 20 seconds and same procedure was repeated for 5 times. Hot moist pack:10 mins for relaxing soft tissue structure, increases extensibility and pain relief. Transcutaneous Electrical stimulator:10 mins for pain relief. Exercises: 10 repetitions- 5 sec hold for strengthening the muscles•	Side bending•	Static abdominal•	Static back extensor•	Side bridging•	Pelvic bridging•	Cat camel.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is information provided after</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rukhsar Amanat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ansari Mobile Phone Center Mohallah abbas nagar narowal</address>
        <city>Narowal</city>
        <country1>Pakistan</country1>
        <zip>540000</zip>
        <telephone>+92 336 8784250</telephone>
        <email>afifaamanat6@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rukhsar Amanat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ansari Mobile Phone Center Mohallah abbas nagar narow</address>
        <city>Narowal</city>
        <country1>Pakistan</country1>
        <zip>540000</zip>
        <telephone>+92 336 8784250</telephone>
        <email>afifaamanat6@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>low back pain less than 12 weeks.
Both gender.
Age 18 to 50 years.
VAS not less than point 3.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>participants having specific low back pain
lumber spondylosis
lumber canal stenosis
sensory deficient
Malignancies
prolapse intervertebral discs with instability or any radicular symptoms
Tuberculosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Participants received routine physical therapy which include TENS with Hot pack and exercises for the strengthening of muscles. Hot Moist pack: 10 mins for relaxing soft tissue structures and increase extensibility. Transcutaneous Electrical stimulator:10 mins for pain relief. Exercises: 10 repetitions- 5 sec hold for strengthening the muscles •Side bending •Side bridging•	Pelvic bridging •Cat camel</i_keyword>
      <i_keyword>Intervention group: Participants received Post-isometric relaxation technique and static stretching with routine physical therapy. Post-isometric relaxation technique: Thirty-nine participants received post-isometric relaxation technique for Quadratus lumborum. Position of the patient is side lying with uppermost arm fully extended. Position of the therapist; behind the patient at waist level. Inhale and abduct the uppermost leg and hold the leg and breathe for 7-10 seconds allowing the gravity to provide resistance. Patient then hang the leg behind him over the back of the table. Release the breath on slowly ceasing contraction. Therapist cradles the pelvis with both hands to take out all slack during exhalation. Hold stretch for 10 seconds. Patient relaxed for 20 seconds and same procedure was repeated for 5 times. Hot moist pack:10 mins for relaxing soft tissue structure, increases extensibility and pain relief. Transcutaneous Electrical stimulator:10 mins for pain relief. Exercises: 10 repetitions- 5 sec hold for strengthening the muscles•	Side bending•	Static abdominal•	Static back extensor•	Side bridging•	Pelvic bridging•	Cat camel</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: outcome measured first at baseline then at the follow up of 3rd week then at 6th week. Method of measurement: pain measured by visual analogue scale.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: outcome measured first at baseline then at the follow up of 3rd week then at 6th week. Method of measurement: Functional disability measured by modified oswestry disability index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>University of Lahore</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of Lahore</source_name>
      <source_name>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-18</approval_date>
        <contact_name>Ethic committee of university of Lahore</contact_name>
        <contact_address>University of lahore new campus Defence road allied bank, lahore Lahore \ narowal Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
