<?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>IRCT2016072229029N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-06</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of trunk balance exercises and whole body vibration on the low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of trunk balance exercises and whole body vibration on the postural control of the patients with chronic non-specific low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23426</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization with block size of four was used. One group was indicated with the letter A and the other with the letter B. Then different blocks of AABB was written. They were assigned the number of 1-6. For example(AABB=1,ABAB=2,BABA=3,BBAA=4,BAAB=5, ABBA=6
A number was randomly selected between 1-6 and the selected number indicated the pattern of assigning individuals to groups, Blinding description: The assessment of ultrasound measurements(muscle thickness and cross sectional area) were conducted by an assessor who was blinded to interventions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>low back pain.</hc_freetext>
      <i_freetext>Intervention 1: In balance training group intervention consists of 18 sessions,3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 micro sec, amplitude as tolerated,  hot pack, US = 1 MHz ,intensity 1.5 w/cm2) are used. After that,  patients execute trunk balance exercises  in 5 levels. The levels of exercises are simple to difficult, and if his/her pain increases, the patient remains at the same level of exercises. The total duration of  treatment is 6 weeks ,3 times per week . Intervention 2: For the whole body vibration group intervention consists of 18 sessions, 3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 micro sec, amplitude as tolerated, hot pack, US = 1 MHz, intensity 1.5 w/cm2) are used. After that , whole body vibration device (sinusoidal mode, frequency= 20 Hz, amplitude= 4mm, a= 5.8 g) is used for them. The patients stands with 20 flexion of knee joints on plate form. 5 boot uses in each session with 1 minute rest between them. Duration of  each boot  in first 2  week is 30 seconds, in second 2 week 45 seconds and in the last 2 week is 1 minute. The total duration of intervention is the  same as other group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>https://doi.org/10.1016/j.medengphy.2018.07.006</results_url_link>
      <results_summary>Patients with low back pain (LBP) have reduced core muscle geometry and impaired postural balance. Impaired trunk control was shown to be associated with poor balance and limited functional mobility in these patients. However, the relationship between muscle geometry and postural balance is unclear. This study aimed to determine the correlation of core muscle geometry with pain intensity, functional disability and postural balance in patients with chronic nonspecific mechanical LBP. Thirty patients aged 20–50 years were enrolled. Ultrasound imaging was used to assess their muscle geometry. The participants completed a numerical rating scale (NRS) for pain severity, and the Persian version of the Roland–Morris Disability Questionnaire (PRMDQ). To estimate static balance, they were asked to perform the single leg stance test. Dynamic balance was assessed with the Y-balance test. Significant correlations were found between NRS scores and bilateral multifidus cross-sectional area during rest ( r ≥−0.31, P ≤0.04) and con- traction ( r ≥−0.37, P ≤0.02). NRS scores correlated significantly with bilateral multifidus thickness during rest ( r ≥−0.31, P ≤0.04) and contraction ( r ≥−0.28, P ≤0.04). Significant correlations were also observed for PRMDQ scores with thickness ( r ≥−0.35, P = 0.04) and cross-sectional area of the multifidus muscles ( r ≥−0.33, P = 0.04) bilaterally during contraction. A significant correlation was found between Y-balance scores and right abdominal muscle thickness during rest and contraction ( r ≥0.34, P ≤0.04). Core muscle geometry correlated with pain, functional disability indices and dynamic balance in these patients.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is To fully protect the data of the participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farahnaz Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abivardi 1 str., Chamran Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3628 9269</telephone>
        <email>emamif@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Razeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abivardi 1 str., Chamran Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3628 9269</telephone>
        <email>razeghm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic non-specific low back pain longer than four months duration
Pain severity  according to a numerical rating scale (NRS) between 3 and 7
Functional disability with a score greater than 8 on the Persian version of the Roland–Morris Disability Questionnaire (PRMDQ)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any dysfunctional entrapment of the nerve roots or history of radicular pain
Leg length discrepancy
Aَny history of hip or knee surgery
َAnkle or foot problems
History of lower extremity orthopedic surgery
Chronic ankle instability
Vestibular and neurological disease
Any uncorrected auditory or visual impairment</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In balance training group intervention consists of 18 sessions,3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 micro sec, amplitude as tolerated,  hot pack, US = 1 MHz ,intensity 1.5 w/cm2) are used. After that,  patients execute trunk balance exercises  in 5 levels. The levels of exercises are simple to difficult, and if his/her pain increases, the patient remains at the same level of exercises. The total duration of  treatment is 6 weeks ,3 times per week .</i_keyword>
      <i_keyword>For the whole body vibration group intervention consists of 18 sessions, 3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 micro sec, amplitude as tolerated, hot pack, US = 1 MHz, intensity 1.5 w/cm2) are used. After that , whole body vibration device (sinusoidal mode, frequency= 20 Hz, amplitude= 4mm, a= 5.8 g) is used for them. The patients stands with 20 flexion of knee joints on plate form. 5 boot uses in each session with 1 minute rest between them. Duration of  each boot  in first 2  week is 30 seconds, in second 2 week 45 seconds and in the last 2 week is 1 minute. The total duration of intervention is the  same as other group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Baseline, End of study. Method of measurement: Y- balance test.</prim_outcome>
      <prim_outcome>Static balance. Timepoint: Baseline, End of study. Method of measurement: Single leg stance test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Differences of thickness of TrA, Internal oblique, External obliqe and multifidus muscles bilaterally. Timepoint: Baseline, End of study. Method of measurement: Rehabilitation Ultrasonography  Imaging.</sec_outcome>
      <sec_outcome>Pain intensity. Timepoint: Baseline, End of study, One month after the end of study. Method of measurement: Visual Analog Scale( VAS).</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: Baseline, End of study, One month after the end of study. Method of measurement: Persian version of the Roland–Morris Disability Questionnaire (PRMDQ).</sec_outcome>
      <sec_outcome>Differences of cross sectional area of  multifidus muscle bilaterally. Timepoint: Baseline, End of study. Method of measurement: Rehabilitative Ultrasonography  Imaging.</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>2016-07-17</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand St., Imam Hossein Square Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
