<?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>IRCT20210321050752N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-06</date_registration>
      <primary_sponsor>Self Supported</primary_sponsor>
      <public_title>Effects of post isometric relaxation technique in patients with gastrocnemius trigger points</public_title>
      <acronym></acronym>
      <scientific_title>Effects of post isometric relaxation technique on pain, range of motion and quality of life in patients with gastrocnemius trigger points</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68734</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomized by using the computer-generated method and further concealed envelop method is used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group, Blinding description: Assessor will only assess the patient at baseline and after follow-up for treatment outcomes.  Assessor safe the data for follow-up and will not share it with any therapist or patient.  At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain in limb.</hc_freetext>
      <i_freetext>Intervention 1: Experimental Physical Therapy Group (B):Group B will be given Post isometric Relaxation along with routine physical therapy including hot pack, range of motion exercises, static stretching and strengthening exercises of gastrocnemius muscle .This will be given upto three sessions per week. Post IsometricRelaxation, Static Stretching and strengthening exercises will provided in three repetitions per session. Each treatment session will have 40-45 minutes duration. Intervention 2: Control group: Routine Physical Therapy Group (A):The routine physical therapy will include hot pack, range of motion exercises, static stretching and strengthening exercises of gastrocnemius muscle .This will be given upto three sessions per week. Hot Pack will be used for 8 minutes in each session. Static Stretching and strengthening exercises will provided into three repetitions per session. Each treatment session will have 30-35 minutes duration.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Numeric pain rating scale will be used for the assessment of pain and Quality of life-related data.

When:
6 months after publication.

To whom:
academic and clinical research writers.

Conditions:
Never without permission.

Where to obtain:
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf

How to obtain:
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54840</zip>
        <telephone>+92 323 5043603</telephone>
        <email>drwaqasfayyaz@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54840</zip>
        <telephone>009232350436033</telephone>
        <email>drwaqasfayyaz@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age is between 25-55 years
Both gender
Long standing workers (at least 3-5 hours of standing work including 5-min seated rest breaks and a 30-min lunch break)
Pre diagnosed patients of calf pain
Numeric pain rating scale (NPRS) scoring ≤ 4
The presence of at least one trigger point in unilateral gastrocnemius muscles.
Jump sign positive. (While compressing the Myofascial Trigger Point, carefully examined the subject’s reaction. A positive jump sign was defined as the subject withdrawing from palpation, wincing, or producingany pain related vocalization)</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Analgesic intake in past 48 hours
Individuals who are already involved in any exercise program for lower extremity
Had a previous history of lateral malleolar, bi malleolar or calcaneal fracture that would affect their gait pattern or strength of the gastrocnemius
Current pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in limb, hand, foot, fingers and toes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental Physical Therapy Group (B):Group B will be given Post isometric Relaxation along with routine physical therapy including hot pack, range of motion exercises, static stretching and strengthening exercises of gastrocnemius muscle .This will be given upto three sessions per week. Post IsometricRelaxation, Static Stretching and strengthening exercises will provided in three repetitions per session. Each treatment session will have 40-45 minutes duration.</i_keyword>
      <i_keyword>Control group: Routine Physical Therapy Group (A):The routine physical therapy will include hot pack, range of motion exercises, static stretching and strengthening exercises of gastrocnemius muscle .This will be given upto three sessions per week. Hot Pack will be used for 8 minutes in each session. Static Stretching and strengthening exercises will provided into three repetitions per session. Each treatment session will have 30-35 minutes duration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Data will be collected at baseline, 4th week and 8th week (follow-up). Method of measurement: Numeric pain rating scale to measure pain.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Data will be collected at baseline, 4th week and 8th week (follow-up). Method of measurement: Quality of life is measured by Short Form-12 (SF-12).</prim_outcome>
      <prim_outcome>Range of Motion. Timepoint: Data will be collected at baseline, 4th week and 8th week (follow-up). Method of measurement: Range of motion is measured by universal goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Self Supported</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-07</approval_date>
        <contact_name>The rules and regulations set by the ethical committee of The University of Lahore wIll be followed.</contact_name>
        <contact_address>RAIWIND ROAD CAMPUS: 1-Km, Raiwind Road, Near Thokar Niaz Big, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
