<?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>IRCT20210528051415N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-28</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>How IASTM and Myofascial Release Alleviate Post-Surgical Elbow Stiffness"</public_title>
      <acronym>IASTM , MFR</acronym>
      <scientific_title>Effects of Instrument-Assisted soft tissue mobilization (IASTM) and myofascial release (MFR) in alleviating post-surgical elbow stiffness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77043</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be done with the help of the lottery method.
With a lottery method, each member of the population is assigned a number, after which numbers are selected at random, Blinding description: Single blinded: outcomes accessors were kept unaware of which participants received the experimental treatment and which received a comparative intervention. This blinding helps to prevent conscious and unconscious biases that could influence the assessment of study outcome.</study_design>
      <phase>3</phase>
      <hc_freetext>Post surgical elbow stiffness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A received IASTM treatment, which was given by the “S-shape tool”, that is an ergonomically designed stainless steel instrument and offers several different hands holds, eliminating operator fatigue. IASTM has drawn more attention for myofascial restriction based upon James Cyriax soft tissue mobilization. Intervention 2: Intervention group: Group B received myofascial release technique was given. Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues. Specific techniques include massage, pressure, skin rolling, twisting, and wringing. Applying pressure and stretch in the direction of the tissue restriction, reportedly causes myofascial lengthening and decreased muscle tension. Intervention 3: Intervention group: Group C received both Instrument-assisted soft tissue mobilization (IASTM) and Myofascial release technique (MFR) in order to check the effect of both treatments collectively.</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:
Effects of instrument -assisted soft tissue mobilization and myofascial release in alleviating post- surgical elbow stiffness
Pain access by NPRS, Range of motion of elbow joint by Goniometer, Functional disability by Liverpool elbow score.

When:
30 days after publication.

To whom:
30 days.

Conditions:
Access to the data will be facilitated through a specified mechanism, such as secure online portal or data sharing platform. Request for access will be renewed by designated committee or entity responsible for insuring that they made an established criteria and comply with relevant regulations and guidelines. Additional supporting information and document may be provided to assist requesters in understanding the available data and its potential application.

Where to obtain:
The University of Faisalabad, 38000 https:/tuf.edu.pk/0092 41 875 0971-5 Fax +92 41 8750970

How to obtain:
To receive the documents or data files, the process typically involves the following steps: 1. Request Initiation: The applicant submits a formal request specifying the documents or data files they need. 2. Verification and Authorization: The organization verifies the request and ensures that the applicant is authorized to access the requested documents or data files. This may involve confirming the identity of the requester and checking their permissions. 3. Processing Time: The processing time varies depending on the complexity of the request, the volume of documents or data files, and any legal or regulatory requirements. It could range from a few hours to several weeks. 4. Document Retrieval or Data Extraction: Once the request is approved, the organization retrieves the documents from their archives or extracts the requested data from their databases. 5. Quality Assurance: Before releasing the documents or data files to the applicant, the organization may conduct quality checks to ensure accuracy and completeness. 6. Delivery: The documents or data files are delivered to the applicant through a secure channel, such as encrypted email, secure file transfer protocols, or a secure online portal. 7. Confirmation of Receipt: The applicant acknowledges receipt of the documents or data files, confirming that they have received the information they requested.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sidra Majeed, PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal town, west canal road, Faisalabad, Punjab.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 7731241</telephone>
        <email>sidra.majeed@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sameer ul Haq, PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal town, west canal road, Faisalabad, Punjab.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 342 0817195</telephone>
        <email>sameerulhaq076@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female
Age: 8–40 years
ROM of elbow extension  ≥–30 degrees &amp; flexion ≤120 degrees
Least 6-week post-surgery with open reduction and internal fixation
Patient with U/L or B/L post-surgical elbow stiffness
Willing to participate were included in this study</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants with any diagnosed auto-immune disorder
Pathological fractures, associated ipsilateral injuries
Bilateral upper extremity injuries
Neuro-vascular disorders
Contraindications for IASTM (as per the IASTM guidelines)
Rheumatic conditions
Circulatory disorders or diabetes
Pregnancy
Inability to Follow Rehabilitation Protocols</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.62</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stiffness of elbow, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A received IASTM treatment, which was given by the “S-shape tool”, that is an ergonomically designed stainless steel instrument and offers several different hands holds, eliminating operator fatigue. IASTM has drawn more attention for myofascial restriction based upon James Cyriax soft tissue mobilization.</i_keyword>
      <i_keyword>Intervention group: Group B received myofascial release technique was given. Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues. Specific techniques include massage, pressure, skin rolling, twisting, and wringing. Applying pressure and stretch in the direction of the tissue restriction, reportedly causes myofascial lengthening and decreased muscle tension.</i_keyword>
      <i_keyword>Intervention group: Group C received both Instrument-assisted soft tissue mobilization (IASTM) and Myofascial release technique (MFR) in order to check the effect of both treatments collectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion. Timepoint: Baseline intervention and 3 weeks post intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Baseline intervention and 3 weeks post intervention. Method of measurement: Numeric pain rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Disability. Timepoint: Baseline intervention and 3 weeks post intervention. Method of measurement: Liverpool elbow score.</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>2024-01-05</approval_date>
        <contact_name>Research and ethics/ technical committee for The University of Faisalabad</contact_name>
        <contact_address>Faisal town, west canal road, Faisalabad, Punjab. Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
