<?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>IRCT20190717044238N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-03</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Physiotherapy effects on SIJ pain</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effects of the suboccipital muscle inhibition technique on pain, functional disability, and quality of life in patients with sacroiliac joint pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68860</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: Patients will be randomly assigned into 2 groups using a computer generated random number table. All those random numbers will be enclosed in sealed envelopes. A third person (who will further not be a part of research) will open envelopes and the patient will be allocated to the mentioned group accordingly, Blinding description: An in dependent assessor, who will be a senior and experienced physiotherapist and will not be part of the study, will assess patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sacroiliac joint pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Group A will receive conventional treatment only which is hot pack for 10 minutes, transcutaneous electrical nerve stimulator (TENS) with 3hz frequency of burst mode for time duration of 10 minutes, therapeutic ultrasound with frequency of 1MHz for a time duration of 5 minutes and muscle energy techniques (2sets, 5repitions, 10 sec hold), will be given to the subject. Intervention 2: Intervention group: : Group B will receive conventional treatment which is hot pack for 10 minutes, transcutaneous electrical nerve stimulator (TENS) with 3hz frequency of burst mode for time duration of 10 minutes, therapeutic ultrasound with frequency of 1MHz for a time duration of 5 minutes and muscle energy techniques (2sets, 5repitions, 10 sec hold), will be given to the subject and new treatment which is sub occipital inhibition technique (performed for 4min until the tissues and muscles were relaxed. During the procedure, patients were asked to keep their eyes closed to avoid eye movements that affect the sub occipital muscle tone).</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 due to patient privacy its undecided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 312 4222341</telephone>
        <email>drahmedjamal912@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>riphah international university lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 334 3372779</telephone>
        <email>fari_fairy22@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both gender
Age 18-25 years old
Sacroiliac pain of chronic level with the duration more than 3months
Patients with positive Leslett’s criteria (The Leslett’s criteria consist of 5 pain provocation test names as Compression test, Distraction test, thigh thrust, Gaenlsen test and Faber test) According to the criteria out of these five tests, if any of the three test indicates positive findings than it is labelled as sacroiliac pain.
The patient with ODI score between 20-40%.•	Patients with NPRS score more than 3 points.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects who had signs of recent surgery
Lumbar spine pathologies like radiculopathies disc herniation, spondylolisthesis, sensory changes in lower back region, osteoporosis
Deformities like torticollis, forward head posture.
Any neurological defect
Any inflammatory or malignant type of pain
Any systemic disease
Pregnancy
Infection
Fractures in the spine</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>Control group: Group A will receive conventional treatment only which is hot pack for 10 minutes, transcutaneous electrical nerve stimulator (TENS) with 3hz frequency of burst mode for time duration of 10 minutes, therapeutic ultrasound with frequency of 1MHz for a time duration of 5 minutes and muscle energy techniques (2sets, 5repitions, 10 sec hold), will be given to the subject.</i_keyword>
      <i_keyword>Intervention group: : Group B will receive conventional treatment which is hot pack for 10 minutes, transcutaneous electrical nerve stimulator (TENS) with 3hz frequency of burst mode for time duration of 10 minutes, therapeutic ultrasound with frequency of 1MHz for a time duration of 5 minutes and muscle energy techniques (2sets, 5repitions, 10 sec hold), will be given to the subject and new treatment which is sub occipital inhibition technique (performed for 4min until the tissues and muscles were relaxed. During the procedure, patients were asked to keep their eyes closed to avoid eye movements that affect the sub occipital muscle tone)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: will be measure on baseline 3 weeks to 6 weeks. Method of measurement: NPRS questionnaire.</prim_outcome>
      <prim_outcome>Disability. Timepoint: will be measure on baseline 3 weeks to 6 weeks. Method of measurement: Oswestry Disability Index for disability.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: will be measure on baseline 3 weeks to 6 weeks. Method of measurement: Health Questionnaire EQ 5D.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-02</approval_date>
        <contact_name>Research and Ethics Committee</contact_name>
        <contact_address>Riphah International University Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
