<?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>IRCT20201108049302N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-28</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>A comparison study of the effect of routine physical therapy and routine physical therapy plus an exercise on the Wobble board on the pain, disability index and Paravertebral muscle endurance in women with chronic nonspecific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>A comparison study of the effect of routine physical therapy and routine physical therapy plus an exercise on the Wobble board on the pain, disability index and Paravertebral muscle endurance in women with chronic nonspecific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52144</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study simple randomization is used. For generating random sequence, table of random numbers generated by stat Trek website is used, there are 40 numbers in this table which are coding from 01 to 40.
After writing the numbers by the researcher, she will read the randomized number from left to right, so the first 20 codes will be in the control group and the second 20 codes will be in the intervention group.
Based on the time of reference , the participants are coding from 01, 02,...40 
till the sample size being completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic nonspecific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 20 patient will be interred in this group and they will receive 8 session routine physical therapy including 20 minuet TENS,10 minute hot pack and a series of exercise including knee to chest and wall stretch as stretching exercises, posterior pelvic tilt and bridge as strengthening exercises and dead-bug and bird-dog as motor control exercises that they will be repeated every day in 3 set of 10 times. Intervention 2: Intervention group: 20 patient will be interred in this group and they will receive 8 session routine physical therapy including 20 minuet TENS,10 minute hot pack and a series of exercise including knee to chest and wall stretch as stretching exercises, posterior pelvic tilt and bridge as strengthening exercises and dead-bug and bird-dog as motor control exercises that they will be repeated every day in 3 set of 10 times. In addition, in this group exercise on the wobble board which is a sitting balance exercise will be done in the clinic for 3 minutes per session in first week progress to 9 minutes per session in 3rd week .</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:
IPD collected for the primary outcome measures only

When:
starting 1 year after publication

To whom:
people working in academic institutions

Conditions:
No limitation

Where to obtain:
fsayban@gmail.com
n_taheri@rehab.mui.ac.ir

How to obtain:
studying the request and the condition

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>فاطمه جراح</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8518668551</zip>
        <telephone>+98 31 4262 0263</telephone>
        <email>fsayban@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8518668551</zip>
        <telephone>009842620263</telephone>
        <email>fsayban@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>30_50 years old females
feeling low back pain more than 12 weeks
Ability of writing and reading
Visual analoge scale : 4 to 8 in last week</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lumbar spine surgery
Spinal canal stenosis
Severe scoliosis(cob. angle &gt;40)
spondylolisthesis (&gt;grade | )
Ankylosing spondylitis
Large disc herniation ( extrusion and sequestration)
Vertebral fracture
Balance disorders
Radiculopathy
BMI&gt;30
Using analgesics or drugs that disturb balance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 20 patient will be interred in this group and they will receive 8 session routine physical therapy including 20 minuet TENS,10 minute hot pack and a series of exercise including knee to chest and wall stretch as stretching exercises, posterior pelvic tilt and bridge as strengthening exercises and dead-bug and bird-dog as motor control exercises that they will be repeated every day in 3 set of 10 times.</i_keyword>
      <i_keyword>Intervention group: 20 patient will be interred in this group and they will receive 8 session routine physical therapy including 20 minuet TENS,10 minute hot pack and a series of exercise including knee to chest and wall stretch as stretching exercises, posterior pelvic tilt and bridge as strengthening exercises and dead-bug and bird-dog as motor control exercises that they will be repeated every day in 3 set of 10 times. In addition, in this group exercise on the wobble board which is a sitting balance exercise will be done in the clinic for 3 minutes per session in first week progress to 9 minutes per session in 3rd week .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain number. Timepoint: before intervention, after intervention and 4 weeks after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Disability index percentage. Timepoint: before intervention, after intervention and 4 weeks after intervention. Method of measurement: Oswestry Disability Index.</prim_outcome>
      <prim_outcome>Paravertebral muscle endurance time. Timepoint: before intervention, after intervention and 4 weeks after intervention. Method of measurement: Sorensen test.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-07</approval_date>
        <contact_name>Ethics committee of Isfahan medical university of science</contact_name>
        <contact_address>No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd. Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
