<?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>IRCT20230105057050N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-17</date_registration>
      <primary_sponsor>Bangladesh Health Professions Institute (BHPI)</primary_sponsor>
      <public_title>Efficacy of shacklock's neural mobilization intervention for reducing pain and disability for patients with lower back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Shacklock’s Neural Mobilization for Acute &amp; Sub-acute Lumbar Disc Prolapsed.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67967</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: 40, Randomization description: This study will be a double-blinded, randomized controlled design. After initial screening, a computer-generated random number will use to allocate participants arbitrarily to the intervention group and control groups. Four Physiotherapists blinded to the allotment procedure administered the
pretest and posttest assessments. Four physiotherapists will provide usual care and another four physiotherapists will provide Shacklock's neural mobilization with usual care. All the therapists who will administer treatment will not be blind but all have training in the study treatment protocol, Blinding description: The assessor and participants are blinded in this study. Investigator employed four assessor for assessment whereas, pre-test and post-test data will be assessed by different assessor and assessors do not know the group allocation.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Lumbar Disc Prolapsed.</hc_freetext>
      <i_freetext>Intervention group.</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:
Name of file will be "Neural Mobilisation". Data will be shared on request to the principal investigator through email.

When:
Data will be available after the end of the study and after publication. Starting in January 2024 and data will be available for next five years.

To whom:
People working in academic institutions.

Conditions:
The principal investigator will review the request and provide the information on the request for further research.

Where to obtain:
Data will be obtainable through email to the principal investigator. Contact person: Zahid Bin Sultan Nahid, email: ranacrpphysio@gmail.com; zahidbinsultannahid@gmail.com, Mobile: +8801717704776; +8801671067313, website: cpmbd.com

How to obtain:
Data will be provided on request through email to the main investigator. email: ranacrpphysio@gmail.com; zahidbinsultannahid@gmail.com

Comments:
This study will emphasize the new treatment protocol on lumbar disc prolapsed in acute and subacute stage.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Md. Anwar Hossain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P.O CRP-Chapain, Savar, Dhaka, Bangladesh.</address>
        <city>Savar</city>
        <country1>Bangladesh</country1>
        <zip>1343</zip>
        <telephone>+8802224445464</telephone>
        <email>anwar.hossain@crp-bangladesh.org</email>
        <affiliation>Bangladesh Health Professions Institute (BHPI)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahid Bin Sultan Nahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CPM, 95 DIT Road, Malibagh, Dhaka, Bangladesh</address>
        <city>Dhaka</city>
        <country1>Bangladesh</country1>
        <zip>1217</zip>
        <telephone>+880 1671-067313</telephone>
        <email>ranacrpphysio@gmail.com</email>
        <affiliation>Center for Physiotherapy &amp; Mobility (CPM)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Bangladesh</country2>
      <country2>Bangladesh</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with acute and sub-acute LBP, diagnosed as lumbar disc prolapsed by MRI.
Patients with low back pain whose symptoms increase in closing movements like lumber extension or, reduce symptoms by opening movements like lumbar flexion of Lumber spine.
Age between 25 to 60 years and both male and female will be included</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with clinical disorders where physiotherapy is contraindicated.
Diagnosed from secondary complications such as fever, weight loss, tumors, Tuberculosis (TB) spine, fracture, dislocation, severe osteoporosis, paget‘s disease, rheumatoid arthritis, ankylosing spondylitis, cauda-equina lesions, cord signs and syndrome, transverse myelitis and all sorts of infection.
Pregnant women.
Medically unstable, mental retardation and unwillingness to participate in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M99.73</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Connective tissue and disc stenosis of intervertebral foramina of lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Dallas Pain Questionnaire using Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability score. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Disability status by Oswestry Disability Index.</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>Bangladesh Health Professions Institute (BHPI)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-25</approval_date>
        <contact_name>Institutional Review Board (IRB), Bangladesh Health Professions Institute (BHPI).</contact_name>
        <contact_address>CRP, Savar, Dhaka, Bangladesh. Savar Dhaka Bangladesh</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
