<?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>IRCT20240724062532N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-19</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Thoracolumbar myofascial release and Graston technique on pain, range of motion and disability among patients with chronic low back</public_title>
      <acronym></acronym>
      <scientific_title>Thoracolumbar myofascial release and Graston technique on pain, range of motion and disability among patients with chronic low back</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79085</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomization clinical trail will be conducted using purposive sampling technique to collect data. Participants will be randomly allocated into two groups by lottery method, Blinding description: A single blinded study is a clinical trial design in which accessor does not know which treatment is administered to the patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Low back pain is a highly prevalent condition that affects individuals worldwide and represents one of the most common complaints in primary care settings. LBP can originate from a variety of sources, including musculoskeletal, neural, and skeletal structures, and may be exacerbated by factors such as prolonged postures, physical strain, and age-related degenerative changes..</hc_freetext>
      <i_freetext>Intervention 1: Experimental group A: Myofascial release technique The intervention to the MFR group will be placed in the prone position for subjects. The therapist will be stand at the subject's back level and will be placed the hands crossed over the spinous processes of the thoracic vertebrae (T12) and the iliac crest. Soft tissue mobilization will be applied for 10 min to the TL area, with the hands moving away from each other and compressing the fascial tissue. Intervention 2: Experimental group B: Soft tissue mobilization with Graston instruments will be applied to the TLF on the GT group. Individuals will be asked to kneel directly on the bed and lie forward. The largest Graston instrument (GT1) will be used for large surface areas and will be chosen for treatment. The Graston instrument will be applied superficially on the TLF between the sacrum and T12 (lumbosacral and lower thoracic region) at an angle of 45° for 10 min. The treatment will be applied to the entire fascial surface without being bound to any direction.</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:
Demographic data and data related to final outcome will be shared by maintaining the confidentially

When:
Data will be available after the publication of findings till six months

To whom:
Ainan Siddique

Conditions:
For researcher purpose

Where to obtain:
To the corresponding author of the study, Ainan Siddique and can contact on +92 323 2323334,ainansiddique980@gmail.com

How to obtain:
Open access and there is the traditional public data release where anyone can get access to the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ainan Siddique</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 323 2323334</telephone>
        <email>ainansiddique980@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ainan Siddique</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 323 2323334</telephone>
        <email>ainansiddique980@gmail.com</email>
        <affiliation>University of Lahore Teaching Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 35 and 50 years
Both Male and females
Low back pain for more than 3 months in a year
Having a 4 score on the Visual Analogue Scale
The prone position must be pain-free for the patients</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of fracture, tumor, and infections
Had undergone any spine-related surgery between Th 12 and S 1
Had radiating pain in the legs, and had pacemakers
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.50</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>Experimental group A: Myofascial release technique The intervention to the MFR group will be placed in the prone position for subjects. The therapist will be stand at the subject's back level and will be placed the hands crossed over the spinous processes of the thoracic vertebrae (T12) and the iliac crest. Soft tissue mobilization will be applied for 10 min to the TL area, with the hands moving away from each other and compressing the fascial tissue.</i_keyword>
      <i_keyword>Experimental group B: Soft tissue mobilization with Graston instruments will be applied to the TLF on the GT group. Individuals will be asked to kneel directly on the bed and lie forward. The largest Graston instrument (GT1) will be used for large surface areas and will be chosen for treatment. The Graston instrument will be applied superficially on the TLF between the sacrum and T12 (lumbosacral and lower thoracic region) at an angle of 45° for 10 min. The treatment will be applied to the entire fascial surface without being bound to any direction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The pain visual analog scale (VAS) is a one-dimensional way to quantify the intensity of pain; it's used for keeping track of how a patient's pain develops over time or for comparing the pain levels of people with similar medical conditions. Timepoint: 8th weeks. Method of measurement: The most basic VAS is a horizontal line with a fixed length, typically 100 mm. At each end of the line are the extremes of the parameter that is going to be measured, on the left side are the worst symptoms, and on the right side are the best health outcomes.</prim_outcome>
      <prim_outcome>When looking for a reduction in lumbar spine range of motion (flexion), as might happen with conditions like ankylosing spondylitis, the traditional gold standard is Schober's test. Timepoint: 8th weeks. Method of measurement: While the patient is upright, the examiner makes two marks on the PSIS and then, in the exact middle of those marks, draws a horizontal line. A second line is indicated fifteen centimeters above the first line. The examiner next has the patient bend forward as if reaching for their toes and takes new measurements from the top and bottom lines.</prim_outcome>
      <prim_outcome>One popular self-report tool for gauging the extent to which low back pain impairs a person's functional capacity and quality of life is the Modified Oswestry Disability Index. Timepoint: 8th weeks. Method of measurement: On a scale from 0 to 5 or 6, the respondent scores their level of disability for each of the ten parts that cover different everyday tasks. A higher percentage indicates a greater degree of disability, as the results are combined and expressed as a whole.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-10</approval_date>
        <contact_name>Research Ethics Committee of University of Lahore</contact_name>
        <contact_address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
