<?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>IRCT20090301001722N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Spinal Manipulation and Muscle Energy Technique on Sacroiliac Joint Dysfunction.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Spinal Manipulation and Muscle Energy Technique on Pain, Function, Thickness of muscles for Patients with Sacroiliac Joint Dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1224</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Four groups will be divided by simple random sampling by using Four alphabetic chance: A) First group, B) second group and C) third group.   D) Fourth Group
Patients will be assigned randomly in Four groups by Physical Therapist (Rabiya) by using concealed opaque envelope mentioning Specific Identity Numbers generated through Random Number Generator to avoid biasness, Blinding description: Double Blind: 

Assessor Blind:

Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to bind Assessors  (Arif, Amir).

Patients Blind:
Patients will be blinded from group treatments and Hypothesis by informing partial information regarding treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sacroiliac Joint Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Muscle Energy Technique.                                                                      Treatment session will be twice a week for four weeks. Intervention 2: Intervention group:  Spinal Manipulation Therapy.                                                                   Treatment session  will be twice a week for four weeks. Intervention 3: Intervention group: Muscle Energy with Spinal Manipulation Therapy.                           Treatment session will be twice a week for four weeks. Intervention 4: Control group: Conventional Therapy such as,Therapeutic Ultrasound.                      Treatment session will be twice a week for four weeks.</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 further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mohammad-Reza Hadian Rasanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Pich e Shemiran, Enghelab Street Tehran Tehran Iran, Islamic Republic Of 1148965141  Tehran  Tehran  Iran, Islamic Republic Of</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 8891 3469</telephone>
        <email>hadianrasan@gmail.com</email>
        <affiliation>Rehabilitation Faculty,Department of Physiotherapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Reza Hadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Pich e Shemiran, Enghelab Street Tehran Tehran Iran, Islamic Republic Of 1148965141</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 8891 3469</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Rehabilitation Faculty, Brain and Spinal Injury Research center (BASIR), Imam Khomeini Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 18-45years old with unilateral LBP upto knee
At least three out of six SIJ provocation tests must be positive.
Standing flexion test and seating flexion test must be positive.
Male
No strengthening exercise of muscles in last three months.
No surgical history
No disc pathology confirmed by MRI
No facet joint hypomobility
No ankylosing spondylitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Abnormal recording of thickness by ultrasound.
Over time and fatigability of subjects.
Unwillingness of subjects to continue testing</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M99.04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the musculoskeletal system and connective tissue,Biomechanical lesions, not elsewhere classified,Segmental and somatic dysfunction,Sacral region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Muscle Energy Technique.                                                                      Treatment session will be twice a week for four weeks.</i_keyword>
      <i_keyword>Intervention group:  Spinal Manipulation Therapy.                                                                   Treatment session  will be twice a week for four weeks.</i_keyword>
      <i_keyword>Intervention group: Muscle Energy with Spinal Manipulation Therapy.                           Treatment session will be twice a week for four weeks.</i_keyword>
      <i_keyword>Control group: Conventional Therapy such as,Therapeutic Ultrasound.                      Treatment session will be twice a week for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before Intervention,After One month,After three months follow up. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Muscle Thickness (Rest,Contracted,Percent change). Timepoint: Muscle Thickness(at rest,contracted and Percent change) will be measured before treatment ,after treatment at one month and follow up three months. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: Function will be measured before treatment , after treatment at one month and follow up three months. Method of measurement: Modified Oswestry Disability Index Score.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-09</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd. Kods street ,Tehran  Tehran  Tehran  Iran, Islamic Republic Of  14167 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
