<?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>IRCT2016080620888N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-18</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences, Vice Chancellory of Research and Technology</primary_sponsor>
      <public_title>Comparing the Effects of Standard Rehabilitation Protocol and Standard Rehabilitation Protocol in Combination with Exercise Therapy in Subjects with Acute Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effects of  Standard Rehabilitation Protocol and Standard Rehabilitation Protocol in Combination with Exercise Therapy, on Functional Disability and Pain in Subjects Affected by Non Specific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18445</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization using random numbers table.</study_design>
      <phase>2</phase>
      <hc_freetext>Acute Nonspecific Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: this group will receive standard treatment including education to stay active, self-management, lumbar school (a pamphlet is used), manipulation in the first two sessions and 30 minutes of transcotaneus electrical nerve stimulation (TENS) in each session. The standard protocol will be administered by the same physical therapist for all the subjects who is blind to the study design. The experimental group will also take part in 8 sessions of active exercises. The exercises are either flexor or extensor muscle endurance training according to the physical evaluation, subject' condition and subject' symptoms. Each exercise will be repeated three boats a day. The exercise will be cancelled and omitted if it aggravates the symptoms. Training progression is according to subjects' capabilities. A physical therapist who is blind to the study design will supervise the exercises. The exercises are kinesthetic (anterior and posterior pelvic tilt), mobility and flexibility (knee to chest, prone extension), muscle performance (drawing in maneuver, alternating flexion/extension of the upper extremities and heel slide) and functional (walking). Intervention 2: Control Group: this group will receive standard treatment including education to stay active, self-management, lumbar school (a pamphlet is used), manipulation in the first two sessions and 30 minutes of transcotaneus electrical nerve stimulation (TENS) in each session. The standard protocol will be administered by the same physical therapist for all the subjects who is blind to the study design.</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>Dr. Zahra Sadat Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>00983137925012; 00983137925042</telephone>
        <email>zrezaeian@yahoo.com; zrezaeian@rehab.mui.ac.ir</email>
        <affiliation>Muscoloskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences,</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahra Sadat Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>00983137925012; 00983137925042</telephone>
        <email>zrezaeian@yahoo.com; zrezaeian@rehab.mui.ac.ir</email>
        <affiliation>Muscoloskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences,</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: meeting at least 5 items of following items: remaining pain even after 7 days of treatment; pain duration less than 6 weeks; no symptoms distal to the knee; one or more hypo-mobile segments in the lumbar spines; Oswestry disability score ≤ 25%; pain intensity ≥ 30% (Visual Analogue Scale).&#13;
&#13;
Exclusion criteria: spine fracture/surgery in the previous 6 months; pregnancy; neoplasia; infection of the spine; visceral pain; systemic disorders; radicular pain due to radiculopathy in last 6 months; sensory impairments; abnormal deep tendon reflexes or muscular weakness due to nerve compression; neurological claudication; psychiatric disorders; osteoporosis; corticosteroid therapy; receiving spinal manipulation previously for the same LBP episode; back pain; segmental spinal instability; administering narcotics; those who may not cooperate; those with contraindications for spinal manipulation; those who meet red flag conditions like fever; trauma; unusual weight loss.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 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>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>Intervention Group: this group will receive standard treatment including education to stay active, self-management, lumbar school (a pamphlet is used), manipulation in the first two sessions and 30 minutes of transcotaneus electrical nerve stimulation (TENS) in each session. The standard protocol will be administered by the same physical therapist for all the subjects who is blind to the study design. The experimental group will also take part in 8 sessions of active exercises. The exercises are either flexor or extensor muscle endurance training according to the physical evaluation, subject' condition and subject' symptoms. Each exercise will be repeated three boats a day. The exercise will be cancelled and omitted if it aggravates the symptoms. Training progression is according to subjects' capabilities. A physical therapist who is blind to the study design will supervise the exercises. The exercises are kinesthetic (anterior and posterior pelvic tilt), mobility and flexibility (knee to chest, prone extension), muscle performance (drawing in maneuver, alternating flexion/extension of the upper extremities and heel slide) and functional (walking).</i_keyword>
      <i_keyword>Control Group: this group will receive standard treatment including education to stay active, self-management, lumbar school (a pamphlet is used), manipulation in the first two sessions and 30 minutes of transcotaneus electrical nerve stimulation (TENS) in each session. The standard protocol will be administered by the same physical therapist for all the subjects who is blind to the study design.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: at the beginning, after first manipulation, after second manipulation, after the 8th therapeutic session, and at one month follow-up. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: at the beginning, after the 8th therapeutic session, and at one month follow-up. Method of measurement: Oswestry Disability Index (ODI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Abdominal Muscle Endurance. Timepoint: at the beginning, after the 8th therapeutic session, and at one month follow-up. Method of measurement: Shirado Test.</sec_outcome>
      <sec_outcome>Back Muscle endurance. Timepoint: at the beginning, after the 8th therapeutic session, and at one month follow-up. Method of measurement: Sorensen Test.</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>Isfahan University of Medical Sciences, Vice Chancellory of Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-26</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
