<?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>IRCT20190618043930N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-14</date_registration>
      <primary_sponsor>khyber medical university</primary_sponsor>
      <public_title>MUSCLE ENERGY TECHNIQUE AND MAITLAND MOBILIZATIONS IN TREATING CHRONIC SACRO ILIAC JOINT DYSFUNCTION</public_title>
      <acronym>SIJD</acronym>
      <scientific_title>COMPARATIVE ANALYSIS ON THE EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE AND MAITLAND MOBILIZATIONS IN THE MANAGEMENT OF CHRONIC SACRO ILIAC JOINT DYSFUNCTION FOR IMPROVING PAIN AND DISABILITY:  A RANDOMIZED CONTROL TRIAL</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2635-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/40307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were recruited in two groups i.e. group A and group B by Randomization through Chit-box method. Group-A (Experimental Group) patients had been treated with MET and Lumbopelvic Stability Exercises and Group-B (Control Group) patients had been treated with Maitland Mobilizations and Lumbopelvic Stability Exercises. 
Chit-Box Method: For random allocation of 60 cases into two groups equally, prepare 60 chits writing “C” (for Control group) on 30 chits and “E” (for Experimental group) on 30 chits. After folding the chits and putting in a box and well mixing, draw a chit, note the letter written on it, and then draw the second chit without replacing the first, note it and proceed similarly until the last i.e. 60th chit is drawn. The generated random allocation sequence may be one as appears in Table below . According to this sequence the first case registered will go to the control group, second case again to the control group, the third to the experimental group and so on to the last case to control group.

Draw	                                          1st 	                   2nd 	                  3rd 	        --	        15th 
Result (Letters on chit)	          C	C	E	C	E	C	C	E	C	C	E	E	--	E	C	E	C
Registered Case No. 
(No. Allocation)	                 1	2	3	4	5	6	7	8	9	10	11	12	--	57	58	59	60, Blinding description: Outcome Assessor has been kept blind during the trial.</study_design>
      <phase>3</phase>
      <hc_freetext>The “Sacroiliac Joint (SIJ) Dysfunction” indicates a pain in the SI joint region that is usually caused by either too much movement (hypermobility) or too little movement (hypo mobility) at the joint that typically results in an irritation of the joint. The mechanical SIJ dysfunction typically causes a dull ache that is located at the base of the spine on the affected side. The pain may become worse and 'sharp' in nature during the activities such as sitting, bending, lifting, standing up from a seated position, or lifting the knee up to the chest during stair climbing. Sometimes the pain can refer to the groin, buttock or the back of the thigh but rarely goes below the knee. The patients with severe and disabling SI joint dysfunction can suffer from insomnia and depression.The main causes of SIJ dysfunction are hypermobility i.e. ligamentous laxity and hypomobility i.e. degenerative joint disease, traumatic incident, hormonal imbalance, unilateral weak lower limb, reversal of concavo-convex locking relationship of SI joint, scoliosis, lumbar spinal fusion, spondyloarthropathies, hip osteoarthritis, femoroacetabular impingement, leg-length inequality, poor-quality footwear, biomechanical or muscle length imbalances..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group-A of 30 patients (Experimental group) was treated with Muscle Energy Technique that was applied on Quadratus Lumborum, Illiopsoas and Piriformis muscles of the affected side for 1 set of 5 repetitions with 10 sec hold along with Lumbopelvic stability exercises which were targeted to the ipsilateral gluteus maximus, contralateral latissimus dorsi and abdominals in 3 sets of 10 reps with 10 sec hold. Intervention 2: Control group: Group-B of 30 patients (Control group) was treated with Sacroiliac Joint Maitland mobilizations in 3 sets of 30 oscillations each on the affected side along with Lumbopelvic stability exercises which were targeted to the ipsilateral gluteus maximus, contralateral latissimus dorsi and abdominals in 3 sets of 10 reps with 10 sec hold.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faryal Zaidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Japan Road Sihala</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 42 111 865 865</telephone>
        <email>faryal.pt@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faryal Zaidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Japan Road, Sihala</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 42 37592112</telephone>
        <email>faryal.pt@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chronic cases of Sacro Iliac Joint dysfunction
Patients with at least moderate score (21%-40%) in Modified Oswestry Disability Index
Patients with 3 or 4 positive Sacro Iliac Joint provocative test</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with Low Back Pain or acute discogenic sciatic pain.
Patients who are previously on injections into SI joint
Piriformis syndrome.
Hip joint pathology
Trochanter pain syndrome
Facet joint arthropathy
Rheumatoid arthritis
Ankylosing spondylitis
Radiculopathy
Visceral referral pain
Stress fracture
Malignancy
Patients with any Co-morbid condition.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group: Group-A of 30 patients (Experimental group) was treated with Muscle Energy Technique that was applied on Quadratus Lumborum, Illiopsoas and Piriformis muscles of the affected side for 1 set of 5 repetitions with 10 sec hold along with Lumbopelvic stability exercises which were targeted to the ipsilateral gluteus maximus, contralateral latissimus dorsi and abdominals in 3 sets of 10 reps with 10 sec hold.</i_keyword>
      <i_keyword>Control group: Group-B of 30 patients (Control group) was treated with Sacroiliac Joint Maitland mobilizations in 3 sets of 30 oscillations each on the affected side along with Lumbopelvic stability exercises which were targeted to the ipsilateral gluteus maximus, contralateral latissimus dorsi and abdominals in 3 sets of 10 reps with 10 sec hold.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PAIN. Timepoint: At the start of intervention and then after one month (12 sessions) of treatment administration. Method of measurement: VAS (Visual Analogue Scale) for measuring the Pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>DISABILITY. Timepoint: At the start of intervention and then after one month (12 sessions) of treatment administration. Method of measurement: MODI (Modified Oswestry Disability Index) for measuring the Disability.</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>khyber medical university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-29</approval_date>
        <contact_name>Advanced Studies &amp; Research Board of Khyber Medical University</contact_name>
        <contact_address>Block-IV PDA building, Phase-V Hayatabad Peshawar Khyber Pakhtunkhwan Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
