<?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>IRCT20170117032020N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-10</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison Two Manual Therapy Techniques and Balance Training in Patients with Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Craniosacral Therapy, Sensorimotor Training and Muscle Energy Technique on Postural control, pain, Functional Disability, Depression and Quality of Life in Low Back Pain Patients and with Malalignment of the Pelvis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were divided into treatment groups using simple randomization. Initially, random numbers were identified through Excel software. A researcher who no participate in sampling, treatment, and assessment, put random numbers into sealed envelopes. The therapist opened envelopes immediately before first treatment session, therefore allocations were concealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Craniosacral therapy (CST); Craniosacral therapy was performed during 10 sessions for 5 weeks. One CST session last about 45 minutes which separates into 4 phase. In each phase, patients were in a specific position for 10 minutes. These phases are 1)Prone position; dominant hand on lower lumbar which moves slightly toward the thoracic and cervical spine and occipital bone; non-dominant hand on the sacrum.2)Side-lying position (behind of therapist) with slightly hip and knee flexion; dominant hand on the occipital bone; non-dominant hand on sacrum.3)Side-lying (in front of the therapist); dominant hand on the frontal bone; non-dominant hand on sacrum 4)Supine position; both hands of temporal and parietal bones of two sides these positions, both the therapist and patient should be relaxed to sense rhythmic CSF and craniosacral movements. Intervention 2: Intervention group: Sensorimotor training, patients receive 10 sessions of balance training during 5 weeks. Patients were progressed through three stage during sessions including static, dynamic and functional. In each stage, patients experience different postures and base of support and their center of gravity is being challenged. Intervention 3: Intervention group: Muscle energy technique, In this group, therapist try finding pelvis rotational and upslip malalignment dysfunctions and then correct them using muscle energy techniques during 10 sessions. to find pelvis malalignment, Standing flexion test, Sitting flexion test, Gillet test, Long to sit test, and location of bony landmarks are used. during performing techniques, shortened muscles contract in a sub-maximal isometric form and then therapist try to move lower limb passively to opposite side in order to correct pelvic dysfunction. The patient can help therapist in this movement.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no furthur information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Iran University of Medical Sciences, Madadkaran Alley, Shah-Nazari Street, Mirdamad Blvd,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459113487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>Koohestan_3000@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Iran University of Medical Sciences, Madadkaran Alley, Shah-Nazari Street, Mirdamad Blvd,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459113487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>amiri.alipt10@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of back pain (from below the costal margin to inferior gluteal folds) for more than 3 months
Pain intensity between 3 and 6 based on visual analogue scale
Pain reduction through reduce the strain on affected segment</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of symptoms such as Neurological pain, Non-mechanical pain, and General Pain
Severe muscle weakness
Presence of significant scoliosis
History of Spinal surgery
Pregnancy during study
spondylolisthesis
Inflammatory diseases</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Craniosacral therapy (CST); Craniosacral therapy was performed during 10 sessions for 5 weeks. One CST session last about 45 minutes which separates into 4 phase. In each phase, patients were in a specific position for 10 minutes. These phases are 1)Prone position; dominant hand on lower lumbar which moves slightly toward the thoracic and cervical spine and occipital bone; non-dominant hand on the sacrum.2)Side-lying position (behind of therapist) with slightly hip and knee flexion; dominant hand on the occipital bone; non-dominant hand on sacrum.3)Side-lying (in front of the therapist); dominant hand on the frontal bone; non-dominant hand on sacrum 4)Supine position; both hands of temporal and parietal bones of two sides these positions, both the therapist and patient should be relaxed to sense rhythmic CSF and craniosacral movements.</i_keyword>
      <i_keyword>Intervention group: Sensorimotor training, patients receive 10 sessions of balance training during 5 weeks. Patients were progressed through three stage during sessions including static, dynamic and functional. In each stage, patients experience different postures and base of support and their center of gravity is being challenged.</i_keyword>
      <i_keyword>Intervention group: Muscle energy technique, In this group, therapist try finding pelvis rotational and upslip malalignment dysfunctions and then correct them using muscle energy techniques during 10 sessions. to find pelvis malalignment, Standing flexion test, Sitting flexion test, Gillet test, Long to sit test, and location of bony landmarks are used. during performing techniques, shortened muscles contract in a sub-maximal isometric form and then therapist try to move lower limb passively to opposite side in order to correct pelvic dysfunction. The patient can help therapist in this movement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Center of pressure displacement. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Force Platform.</prim_outcome>
      <prim_outcome>Mean of Anterior-posterior Center of pressure location. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Force Platform.</prim_outcome>
      <prim_outcome>Mean of medial-lateral Center of pressure location. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Force Platform.</prim_outcome>
      <prim_outcome>Center of pressure displacement velocity. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Force Platform.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Ostwestry Disability Index. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Ostwestry Disability Questionnaire.</sec_outcome>
      <sec_outcome>Depression Score. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Beck Depression Inventory-II.</sec_outcome>
      <sec_outcome>Quality of Life score. Timepoint: Before intervention, 5 weeks after, and 2 months follow-up. Method of measurement: Short-form 36 Questionnaire of Quality of Life.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-11</approval_date>
        <contact_name>Ethical commitee of Iran University of Medical Sciences</contact_name>
        <contact_address>Next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
