<?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>IRCT20090203001637N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-20</date_registration>
      <primary_sponsor>Research deputy of Tarbiat Modares University</primary_sponsor>
      <public_title>Study and comparison of two therapeutic exercise approach with and without manual therapy on improving pain, range of motion , functional disability and balance in patients with low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Combination therapy "SNAG - Lumbar Stabilization Exercise" treatment versus Stabilizing Exercises on improving pain, range of motion , functional disability and postural stability in patients with chronic non-specific low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method is  performed by simple randomization with random numbers, Blinding description: Participants were aware of two methods of interventions, but they were blind to the type of treatment intervention  used for them .</study_design>
      <phase>N/A</phase>
      <hc_freetext>patients with nonspecific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Combination of Mulligan Mobilization with Stabilization Exercise. Intervention 2: Intervention group:Stabilization Exercise protocol.</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:
File of Intervention program protocol  and Statistical analysis plan through publication of thesis or writing an article.

When:
Starting 6 months after publication of results.

To whom:
Research team of this study and other clinical academic researchers who are studying in favor of these patients.

Conditions:
Researchers who intend to write a meta-analysis or systematic review articles are allowed to access documents.

Where to obtain:
Dr.Sedighe Kahrizi(kahrizis@modares.ac.ir)
Mehrnoosh Danaeifar(mehrnoosh.danaeifar92@gmail.com)

How to obtain:
The request will be responsed after getting the approval of university or the Academic Institution.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoosh Danaeifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat modares university, Tehran, JALAL E al ahmad Avenue , Nasr bridge</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4511</telephone>
        <email>Mehrnooshdanaeifar@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Kahrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Jalal e Al Ahmad Avenue , Nasr Bridge, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4511</telephone>
        <email>kahrizis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having age between 25 to 50.
Having at least  high school diploma education.
Having chronic non-specific chronic back pain for more than three months without neurological deficit.
Having body mass index between 20 to 25  (kg/m2).
Having localized pain at the waist level between 3 to 6 as VAS (Visual Analog Scale 0-10 centimeter) ,  during lumbar extension  in sitting position on test day.
Having positive  PILL Response scale(pain free ,immediate ,long lasting )  as Mulligan concept.
having  functional disability  between 20-40 % as Oswestry questionnaire.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having history of trauma,surgery in back or stomach ,fracture in  vertebral spine .
having any  sign and symptom  of pressure on cauda equinq nerve.
Presence of pregnancy, infection, tumor, inflammation and swelling, osteoporosis, rheumatism, systemic and neuromuscular diseases.
Having any deformity in vertebral spine.
Having a history of physical  therapy for back pain in the last 3 months.
Use of analgesics.
Presence of disk protrusions (based on MRI) and diagnosis of orthopedic surgeon.
Presence of referral pain from lumbar to under the legs or  the knees.
Losing   any of inclusion criteria.</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>Combination of Mulligan Mobilization with Stabilization Exercise</i_keyword>
      <i_keyword>Intervention group:Stabilization Exercise protocol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Pre-post  of the  interventions in  the first session  and  a day after the last session(seventh session)last session(seventh session). Method of measurement: Force plate system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional disability. Timepoint: Pre-post  of the  interventions in  the first session  and  a day after the last session(seventh session). Method of measurement: Oswestry Questionaire.</sec_outcome>
      <sec_outcome>Pain in lumbar spine. Timepoint: Pre-post  of the  interventions in  the first session  and  a day after the last session(seventh session). Method of measurement: Visual analog scale (VAS).</sec_outcome>
      <sec_outcome>Range of motion of lumbar vertebral. Timepoint: Pre-post  of the  interventions in  the first session  and  a day after the last session(seventh session). Method of measurement: Modified modified Schober method.</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>Research deputy of Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-28</approval_date>
        <contact_name>Ethics committee of  Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University , Nasr bridge , Jalal e al e ahmad street , Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
