<?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>IRCT20220604055072N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-16</date_registration>
      <primary_sponsor>Rashid Latif Medical College</primary_sponsor>
      <public_title>Comparative effect of diaphragmatic training and myofascial release on pain, flexibility and disability in patients with chronic non-specific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of diaphragmatic training and myofascial release on patients with chronic non-specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82685</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated randomly to study groups using the lottery method. Each patient was asked to draw a closed slip marked with number 1 or 2 from a box. Group A include participants in box number one, while group B include participants of box number two. 48 patients were allocated based on randomization in two groups equally, i.e., 24 in each group, Blinding description: The interventions were based on outpatient rehabilitation program in both groups. The study participants were blind about groups a treatment protocol.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Diaphragm Training. The diaphragm has a dual role of respiration and postural control.  However, the role of the diaphragm is often overlooked in core stability exercise regime low back pain rehabilitation. Abdominal hollowing exercise, also known as the ‘tummy tuck’ exercise focusing on TrA and lumbar multifidus. Diaphragmatic breathing on activation of trunk muscles of patients with low back pain. Diaphragmatic breathing may affect activation of trunk muscles.  Diaphragmatic breathing increases intra-abdominal pressure, and the increased intra-abdominal pressure may contribute to the lumbar stability. Experimental group performed diaphragmatic breathing exercise with six breathing positions. First week: Supine breathing + Crocodile breathing. Second week: Supine breathing with TheraBand + Crocodile breathing with TheraBand. Third week: Seated breathing + 90/90/90 breathing Fourth week: Seated breathing with TheraBand + TheraBand. Intervention 2: Comparative Intervention group: Myofascial Release technique. Myofascial release technique diaphragm performed as follow: The participant lay supine with relaxed limbs. Positioned at the head of the participant, the therapist made manual contact with the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages, with the therapist's forearms aligned toward the participant's shoulders. In the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, the therapist deepened contact toward the inner costal margin, maintaining resistance. The manoeuvre was performed in two sets of 10 deep breaths, with a 1-minute interval between them.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadia Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 305 4501212</telephone>
        <email>areejsaadia@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadia Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 305 4501212</telephone>
        <email>areejsaadia@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants were included if they had intermittent nonspecific CLBP for ≥12 weeks, with VAS between 3 to 7. All participants were active at a recreational level, for 2–4 times per week, since at least 3 years.
Patients with low back pain without radiculopathy
Individual willing to participate in study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Upper abdominal surgery
Lumbar surgery experience
Inflammatory spinal disease
Spinal deformities
Neurologic radiating pain</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>Intervention group:  Diaphragm Training. The diaphragm has a dual role of respiration and postural control.  However, the role of the diaphragm is often overlooked in core stability exercise regime low back pain rehabilitation. Abdominal hollowing exercise, also known as the ‘tummy tuck’ exercise focusing on TrA and lumbar multifidus. Diaphragmatic breathing on activation of trunk muscles of patients with low back pain. Diaphragmatic breathing may affect activation of trunk muscles.  Diaphragmatic breathing increases intra-abdominal pressure, and the increased intra-abdominal pressure may contribute to the lumbar stability. Experimental group performed diaphragmatic breathing exercise with six breathing positions. First week: Supine breathing + Crocodile breathing. Second week: Supine breathing with TheraBand + Crocodile breathing with TheraBand. Third week: Seated breathing + 90/90/90 breathing Fourth week: Seated breathing with TheraBand + TheraBand.</i_keyword>
      <i_keyword>Comparative Intervention group: Myofascial Release technique. Myofascial release technique diaphragm performed as follow: The participant lay supine with relaxed limbs. Positioned at the head of the participant, the therapist made manual contact with the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages, with the therapist's forearms aligned toward the participant's shoulders. In the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, the therapist deepened contact toward the inner costal margin, maintaining resistance. The manoeuvre was performed in two sets of 10 deep breaths, with a 1-minute interval between them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre-intervention and Post-4 week intervention. Method of measurement: Pain level was assessed by the Numerical Rating Scale (NRS). The participants rated their pain on a defined 0–10 scale, where 0 is no pain, and 10 is the worst pain imaginable.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Pre-intervention and Post-4 week intervention. Method of measurement: The ODI is one of the most common scoring systems used for patients with LBP. The total score ranges from 0 to 100, where a higher score indicates a higher level of disability.</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: Pre-intervention and Post-4 week intervention. Method of measurement: The examiner puts his thumbs on the inferior margin of the subject’s PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the examiner holds the tape firmly against the subject’s skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion.</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>Rashid Latif Medical College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-12</approval_date>
        <contact_name>The Institutional Review Board of Rashid Latif Medical College</contact_name>
        <contact_address>25-Km Ferozepur road Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
