<?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>IRCT2016080812953N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-28</date_registration>
      <primary_sponsor>Deputy of Research in school of rehabilitation sciences of Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise on lumbar and hip joints coordination in patients with chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effects of core stability versus general trunk exercises on the kinematics and joint coordination of the lumbar spine and hip during sit-to-stand and stand-to-sit in patients with chronic non-specific low back pain: A randomised double-blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Patients with chronic non-specific low back pain will be divided into 2 groups: one group will receive core stability exercises and the other group will receive general trunk exercises:&#13;
&#13;
The first intervention group: core stability exercises: Core stability exercises or motor control exercises are designed to re-educate the co-activation pattern of abdominals, paraspinals, gluteals, pelvic floor muscles, and diaphragm. The biological rationale for core stability exercises is primarily based on the idea that the stability and control of the spine are altered in patients with low back pain. A core stability exercise programme begins with recognition of the natural position of the spine (mid-range between lumbar flexion and extension range of motion), considered to be the position of balance for improving performance in various sports. Initial low-level sustained isometric contraction of trunk stabilising muscles and their progressive integration into functional tasks is the requirement of core stability exercises. To ensure correct activation of the transversus abdominis muscle, it will be emphasized to chronic non-specific low back pain participants that the lower part of the anterior abdominal wall below the umbilical level is needed to be ‘‘drawn in’’ during contraction of this muscle. Furthermore, bulging action of the multifidus muscle is needed to be felt under the physical therapist’s fingers when they are placed on either side of the spinous processes of the L4 and L5 lumbar vertebral levels, directly over the belly of the muscle.&#13;
&#13;
The second intervention group: general exercises: General exercises are an umbrella term that can involve strengthening exercises for all the main muscle groups with or without the addition of weights. In addition, this umbrella term can consist of exercises improving coordination, stretching, and aerobic fitness training. In our study, exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be performed. They will be conducted in a lying position initiating with simple movements and progressing to more difficult exercises (eg, on a gym ball).&#13;
&#13;
The same frequency (3 times per week [Saturday, Monday, Wednesday]) and duration (5 weeks [16 sessions]) will be provided for both groups. In each session, participants will be instructed to perform their exercises as many times as they can with rest periods in the same session. The holding time and then the number of contractions will be progressively increased up to 10 contraction repetitions × 10-second duration each. Finally, exercises set will be increased from 3 to 5 sets. Chronic non-specific low back pain participants in the core stability exercise group will be asked to activate their muscles at about 30% of their maximum activation level during the performance of stabilization exercises and chronic non-specific low back pain participants in the general exercise group will be asked to activate their muscles at about 60% to 70% during the performance of general exercises. In this study Shamsi et al. (2015) exercise programme will be used. All these exercises will be performed under supervision of an experienced physical therapist. Moreover, to control confounding variables and creating a standard and homogeneous condition for all chronic non-specific low back pain participants, they will be instructed not to perform exercises at home between the treatment sessions. Intervention 2: In this study, the control group will include demographically matched healthy participants and the kinematic variables of chronic non-specific low back pain participants will be compared with healthy participants before and after intervention.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Pourahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>pourahmadipt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ismail Ebrahimi Takamjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>dr_i_ebrahimi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- Chronic non-specific low back pain (low back pain persisting for more than 3 months in the absence of an underlying pathology); 2- Age between 18 and 40 years; 3- Pain between 3 and 6 on a 0- to 10-point pain visual analogue scale (VAS), where 0 represents no pain and 10 is the worse pain imaginable; 4- No contraindication for exercise; 5- No obvious deformity of the spine, pelvis, and lower extremities; 6- No autoimmune diseases (e.g. rheumatoid arthritis); and 7- Pregnancy. &#13;
&#13;
Exclusion criteria:&#13;
1- Absence for 3 consecutive, or a total of 5 sessions; and 2- Participant's request for termination of participation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Loin pain, Low back strain, Lumbago NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients with chronic non-specific low back pain will be divided into 2 groups: one group will receive core stability exercises and the other group will receive general trunk exercises:&#13;
&#13;
The first intervention group: core stability exercises: Core stability exercises or motor control exercises are designed to re-educate the co-activation pattern of abdominals, paraspinals, gluteals, pelvic floor muscles, and diaphragm. The biological rationale for core stability exercises is primarily based on the idea that the stability and control of the spine are altered in patients with low back pain. A core stability exercise programme begins with recognition of the natural position of the spine (mid-range between lumbar flexion and extension range of motion), considered to be the position of balance for improving performance in various sports. Initial low-level sustained isometric contraction of trunk stabilising muscles and their progressive integration into functional tasks is the requirement of core stability exercises. To ensure correct activation of the transversus abdominis muscle, it will be emphasized to chronic non-specific low back pain participants that the lower part of the anterior abdominal wall below the umbilical level is needed to be ‘‘drawn in’’ during contraction of this muscle. Furthermore, bulging action of the multifidus muscle is needed to be felt under the physical therapist’s fingers when they are placed on either side of the spinous processes of the L4 and L5 lumbar vertebral levels, directly over the belly of the muscle.&#13;
&#13;
The second intervention group: general exercises: General exercises are an umbrella term that can involve strengthening exercises for all the main muscle groups with or without the addition of weights. In addition, this umbrella term can consist of exercises improving coordination, stretching, and aerobic fitness training. In our study, exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be performed. They will be conducted in a lying position initiating with simple movements and progressing to more difficult exercises (eg, on a gym ball).&#13;
&#13;
The same frequency (3 times per week [Saturday, Monday, Wednesday]) and duration (5 weeks [16 sessions]) will be provided for both groups. In each session, participants will be instructed to perform their exercises as many times as they can with rest periods in the same session. The holding time and then the number of contractions will be progressively increased up to 10 contraction repetitions × 10-second duration each. Finally, exercises set will be increased from 3 to 5 sets. Chronic non-specific low back pain participants in the core stability exercise group will be asked to activate their muscles at about 30% of their maximum activation level during the performance of stabilization exercises and chronic non-specific low back pain participants in the general exercise group will be asked to activate their muscles at about 60% to 70% during the performance of general exercises. In this study Shamsi et al. (2015) exercise programme will be used. All these exercises will be performed under supervision of an experienced physical therapist. Moreover, to control confounding variables and creating a standard and homogeneous condition for all chronic non-specific low back pain participants, they will be instructed not to perform exercises at home between the treatment sessions</i_keyword>
      <i_keyword>In this study, the control group will include demographically matched healthy participants and the kinematic variables of chronic non-specific low back pain participants will be compared with healthy participants before and after intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion. Timepoint: before and after 16 treatment sessions. Method of measurement: Motion capture system and conducting analysis.</prim_outcome>
      <prim_outcome>Angular velocity. Timepoint: before and after 16 treatment sessions. Method of measurement: Motion capture system and conducting analysis.</prim_outcome>
      <prim_outcome>Phase angle. Timepoint: before and after 16 treatment sessions. Method of measurement: Motion capture system and conducting analysis.</prim_outcome>
      <prim_outcome>Lumbar spine to right/left hip ratio. Timepoint: before and after 16 treatment sessions. Method of measurement: Motion capture system and conducting analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: before and after 16 treatment sessions. Method of measurement: Visual analogue scale.</sec_outcome>
      <sec_outcome>Disability. Timepoint: before and after 16 treatment sessions. Method of measurement: Roland-Morris Disability and Oswestry Low Back Disability Questionnaires.</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>Deputy of Research in school of rehabilitation sciences of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-27</approval_date>
        <contact_name>Research Ethics Committee at Iran University of Medical Sciences and Health services</contact_name>
        <contact_address>Iran University Campus, Hemmat freeway, next to Milad tower Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
