<?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>IRCT20200218046542N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Pain Neuroscience Education technique on Nonspecific chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of lumbosacral manipulation with and without pain neuroscience education method in treatment of nonspecific chronic low back pain in athlete with sacroiliac dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46034</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed by permutation block randomization method with 4-digit blocks (two groups of 19 subjects), Blinding description: The researcher who will do the manipulation and assess the outcome measures, as well as the statistic specialist will be unaware of the control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain with sacroiliac dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Performing sacroiliac and lumbar manipulation similar to the control group with a pain neuroscience education technique that teaches about pain management and control it.This technique is performed in three sessions and each session is about 90 minutes before other interventions by PowerPoint and clip And within a month, the taught material will be sent every week to remind them. In fact, PNE technique creates a new perception of the past and previous experience, Due to the lack of focus on the damaged tissue and Pain is taught simply in neurobiology and neurophysiology. In other words, the patient is informed about the mechanism of pain and neuroanatomy in practice And this makes it possible to identify false pains of psychological origin and improve them. Intervention 2: Control group: only perform lumbar and sacroiliac manipulation techniques as baseline treatment in three sessions.</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:
The results will be published as an article in the research international journals

When:
In the next 1 to 2 years

To whom:
Only people who ask the main investigator for the information

Conditions:
With the permission through a written or oral request

Where to obtain:
School of Rehabilitation Sciences. Shiraz University of Medical Sciences

How to obtain:
School of Rehabilitation Sciences. Shiraz University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Mahdi Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 3, West Mardani, Janbazan Blvd., Modares Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7155816345</zip>
        <telephone>+98 71 3720 7692</telephone>
        <email>m_soltani@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Mahdi Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3 West Mardani St., Janbazan Blvd., Modares Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7155816345</zip>
        <telephone>+98 71 3720 7692</telephone>
        <email>m_soltani@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-specific chronic low back pain
Who performed specialized exercise at least three times a week for two hours each session
Pain between 3 to 6 based on the NRS
Functional disability between 20 to 40 based on the ODI questionnaire
Catastrophizing pain between 26 and 39 based on the PCS questionnaire
sacroiliac dysfunction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>32 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction
Do additional therapy in addition to the treatment specified in the study
Patients who are included in one of the cases of absolute non-use of interventions such as Recent infections, cancer, use anticoagulants, lymphedema, etc.
History of spine surgery
Osteoporosis
Leg length difference
Use of painkillers and anti-inflammatory drugs over the past three months
Recent physiotherapy in the past three months
Spinal deformities including scoliosis
Cauda equina syndrome
Neurological symptoms from pressure on the nerve
Disc herniation
Pregnancy
Inability to read and write
Having medical or paramedical information (such as neuroanatomy-neurophysiology information)</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Performing sacroiliac and lumbar manipulation similar to the control group with a pain neuroscience education technique that teaches about pain management and control it.This technique is performed in three sessions and each session is about 90 minutes before other interventions by PowerPoint and clip And within a month, the taught material will be sent every week to remind them. In fact, PNE technique creates a new perception of the past and previous experience, Due to the lack of focus on the damaged tissue and Pain is taught simply in neurobiology and neurophysiology. In other words, the patient is informed about the mechanism of pain and neuroanatomy in practice And this makes it possible to identify false pains of psychological origin and improve them.</i_keyword>
      <i_keyword>Control group: only perform lumbar and sacroiliac manipulation techniques as baseline treatment in three sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before, after 3 sessions and after one month. Method of measurement: Numerical rate scale.</prim_outcome>
      <prim_outcome>Functional disabilities. Timepoint: Before, after 3 sessions and after one month. Method of measurement: Oswestry disability index.</prim_outcome>
      <prim_outcome>Pain catasrophizing rate. Timepoint: Before, after 3 sessions and after one month. Method of measurement: pain catastrophizing scale questionnare.</prim_outcome>
      <prim_outcome>Static balance with closed eyes. Timepoint: Before,after 3 sessions and after one month. Method of measurement: Single leg stance bilateraly with closed eyes.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-31</approval_date>
        <contact_name>Ethics committee of Shiraz university of Medical Sciences</contact_name>
        <contact_address>Zand Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
