<?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>IRCT20200117046160N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-08</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Exercises impacts on patients with chronic low back pain</public_title>
      <acronym>NSLBP</acronym>
      <scientific_title>Comparing the effect of Feldnkaris method and core stability exercise on pain and disability of  patients with Non specific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45106</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients have inclusion criteria were randomly divided into two groups: Feldenkrais and Core stability exercise therapy. They received exercise therapy for 5 weeks. At the beginning and the end of the study same measurements were evaluated for both groups. for both groups were evaluated, Randomization description: Systematic random allocation of patients will be done using "Random allocation Generation web site", Blinding description: The survey was double blinded. Both participants and valuator were not aware of the allocation method of study groups. although participants were unaware of two different exercise groups of study, they knew about their own group of exercise therapy group. the final valuator was not informed about the course of exercise therapy in each particiapnt.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Core stability exercises group were performed for 5 weeks. Patients were trained every two weeks in the clinic and were required to perform the exercise three times a day, ten times each, with a 10-second isometric contraction. Patients were followed up by a researcher over the phone for two weeks. If the pain rises to above three score, exercises were stopped or they would be taken to the previous stage,  if physician agreed. The exercises were progressive in two models on the ground and sport ball. Intervention 2: The Feldnkaris is a body-mind exercise method, included from 5 weeks of treatment protocol based exercises. All the exercises were taught under the supervision of the researcher, in groups of 10, twice a week and 1 to 2 hours each session. the exercises consisted of: breathing techniques, cervical, thoracic, lumbar spine mobilization, shoulder and hip joint range of motion, concentration and body awareness and relaxation exercises, correction of posture in lying, sitting, standing, and stretching exercises and improved flexibility and reduce motor resistance were in the aforementioned joints and muscles and spine.</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:
All recorded data will be reachable for clinical and academic researchers for one year after the article publications as non-identifiable files.

When:
Accessibility to the data will be possible 6 months after the article publication for the applicants, for one year.

To whom:
Clinical and academic researchers

Conditions:
Using the documents only under the permission of the head researcher, providing participation in the ongoing research.

Where to obtain:
1.Hanieh Adib by Email Address: Hanieadib@gmail.com
2. Hanieh Ahmadi by Email Address: Hani.medico@gmail.com

How to obtain:
The request should be emailed to corresponding author, identifiable ID card and reason of request must be noted . After confirmation of  their documents, data would be emailed within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Adib</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 6, 3th Ave, Razi St,  Mostafavian Clinic</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816868890</zip>
        <telephone>+98 11 3336 6552</telephone>
        <email>hanieadib@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 6,   3th Ave,  Razi St, Mostafavian Clinic,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816868890</zip>
        <telephone>+98 11 3336 6552</telephone>
        <email>hani.medico@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Clinical diagnosis of CNSLBP (Chronic non specific low back pain)
Patients age:18-68</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>68 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with diagnosis of specific or acute low back pain
Patients under 18 or above 68 yrs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic 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>Core stability exercises group were performed for 5 weeks. Patients were trained every two weeks in the clinic and were required to perform the exercise three times a day, ten times each, with a 10-second isometric contraction. Patients were followed up by a researcher over the phone for two weeks. If the pain rises to above three score, exercises were stopped or they would be taken to the previous stage,  if physician agreed. The exercises were progressive in two models on the ground and sport ball.</i_keyword>
      <i_keyword>The Feldnkaris is a body-mind exercise method, included from 5 weeks of treatment protocol based exercises. All the exercises were taught under the supervision of the researcher, in groups of 10, twice a week and 1 to 2 hours each session. the exercises consisted of: breathing techniques, cervical, thoracic, lumbar spine mobilization, shoulder and hip joint range of motion, concentration and body awareness and relaxation exercises, correction of posture in lying, sitting, standing, and stretching exercises and improved flexibility and reduce motor resistance were in the aforementioned joints and muscles and spine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain score in McGill questionnaire. Timepoint: Before and after intervention. Method of measurement: McGill questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Low Back Pain Disability Score in Oswestry questionnaire. Timepoint: Before and after intervention. Method of measurement: Oswestry questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-19</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences, Imam Hospital</contact_name>
        <contact_address>Imam Hospital, Amir Mazandarani St, Imam Sq, Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
