<?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>IRCT20240528061931N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-24</date_registration>
      <primary_sponsor>the university of Faisalabad</primary_sponsor>
      <public_title>Myofascial Release Therapy and Post Isometric Relaxation in post-traumatic Elbow stiffness</public_title>
      <acronym>Randomized Clinical Trial</acronym>
      <scientific_title>Comparative effectiveness of Myofascial Release Therapy and Post Isometric Relaxation in post-traumatic Elbow stiffness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77070</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this study, non-probability purposive sampling was initially used to select participants. For randomization, participants were divided into two treatment groups using the lottery method. Each participant’s allocation was determined by drawing a numbered slip from a container. The slips were shuffled thoroughly to ensure randomness. Allocation concealment was maintained by keeping the process anonymous until the slip was drawn, Blinding description: participant was blinded.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Post-Traumatic Elbow stiffness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention : Group A (Myofascial Release Therapy - MFR)                                                              Frequency :3 times /2 weeks, total of 6 sessions.                                                                                  Hold Time (per repetition):30-60 seconds per repetition.                                                                         Repetitions: 2 rep.                                                                                                                                Baseline Treatment: Ice (20-30 minutes) and Maitland mobilization.                                                     Dosage: 5 mins/session, 3 sessions/ week.                                                                                              Total Dosage:15mins/week, total 30 mins over 2 weeks. Intervention 2: Intervention : Group B (Post-isometric Relaxation Technique - PIR).                                        Frequency:3 times a week for 2 weeks, total of 6 sessions.                                                                  Hold Time (per repetition) : 5-10 seconds per contraction.                                                           Repetitions:3-5 repetitions.                                                                                                                       Baseline Treatment: Ice (20-30 minutes) and Maitland mobilization.                                             Dosage; 10mins/session,3sessions/week.                                                                                             Total Dosage :30mins/week, total 60 minutes over 2 week.</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:
Myofascial Release and Post Isometric Relaxation for the management of post operative elbow stiffness

When:
July 1, 2024, the documents/data files will become available on January 1, 2025, and will remain accessible until December 31, 2025.

To whom:
Academic Institutions

Conditions:
Deidentified IPD and supporting documents will be shared for academic and policy research via a formal request process reviewed by a Data Access Committee, ensuring ethical and secure use.

Where to obtain:
Applicants should email asmazafar522@gmail.com for data files, or contact at 0092 3040790805 for assistance.

How to obtain:
Applicants must submit a request form via email, await review by the Data Access Committee, sign a Data Use Agreement, and this process typically takes 4-6 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asma zafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sitara colony , FSD.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>37000</zip>
        <telephone>+92 304 0790805</telephone>
        <email>Asmazafar522@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asma Zafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sitara colony , FSD.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>37000</zip>
        <telephone>+92 304 0790805</telephone>
        <email>Asmazafar522@gmail.com</email>
        <affiliation>THE UNIVERSITY OF FAISALABAD</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age ranging from 15 to 50 years old
Pain (NPRS score from 3-7)
Stiff elbow
After 6 weeks of surgery
Restricted ROM: subjects with limited active range of motion A(ROM)
Both male &amp; female patients
Participants willing for the enrollment in the study.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Open wound
ROM not improved after 2nd session
Acute infection to the elbow region
Cervical radiculopathy &amp; any other upper limb dysfunction
Neurological impairments
Pregnant females
Psychological condition
Refusal to consent
Any Co-morbidity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stiffness of unspecified elbow, Stiffness of right elbow, Stiffness of left elbow.</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>Intervention : Group A (Myofascial Release Therapy - MFR)                                                              Frequency :3 times /2 weeks, total of 6 sessions.                                                                                  Hold Time (per repetition):30-60 seconds per repetition.                                                                         Repetitions: 2 rep.                                                                                                                                Baseline Treatment: Ice (20-30 minutes) and Maitland mobilization.                                                     Dosage: 5 mins/session, 3 sessions/ week.                                                                                              Total Dosage:15mins/week, total 30 mins over 2 weeks.</i_keyword>
      <i_keyword>Intervention : Group B (Post-isometric Relaxation Technique - PIR).                                        Frequency:3 times a week for 2 weeks, total of 6 sessions.                                                                  Hold Time (per repetition) : 5-10 seconds per contraction.                                                           Repetitions:3-5 repetitions.                                                                                                                       Baseline Treatment: Ice (20-30 minutes) and Maitland mobilization.                                             Dosage; 10mins/session,3sessions/week.                                                                                             Total Dosage :30mins/week, total 60 minutes over 2 week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Numeric Pain Rating Scale(NPRS). Timepoint: pain is evaluated through NPRS once before first session and after each session , total no. of session=6. Method of measurement: The NPRS is a validated tool to quantify pain levels  ranging from 0 to 10, with 0 indicating no pain and 10 representing the worst  pain.</prim_outcome>
      <prim_outcome>•	•	Universal goniometer to measure elbow flexion and extension. Timepoint: once before and  1st session and after last session, total no. of session =6. Method of measurement: •	Universal goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>•	Liverpool elbow score to measure function. Timepoint: once before 1st session and then at session 6, total no. of session=6. Method of measurement: Liverpool elbow score Questionaire.</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>the university of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-17</approval_date>
        <contact_name>The University of Faisalabad</contact_name>
        <contact_address>Sitara colony , FSD. Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
