<?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>IRCT20230216057434N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-15</date_registration>
      <primary_sponsor>Self funded</primary_sponsor>
      <public_title>Effectiveness of two manual therapy technique in piriformis syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Active Release Technique and Myofascial Release technique on pain, range of motion and functional Disability in patients with Piriformis syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68891</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through a computer software "Random allocation". The total sample size will be entered with requirement to be allocated in two groups. An automated randomization list will be achieved with attrition rate included, Blinding description: Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will received
Patients will also be blinded about the type of intervention they will receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Piriformis Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group A (active release technique) 22 patients in Group A will receive active release technique (ART) and conventional treatment in the form of hot pack for 10-15 minutes followed by piriformis muscle stretch for 10 seconds hold (3 sets of 10 repetitions) for a duration of 15 minutes. ART will be applied with patients in prone lying with knee flexed at 90°.the therapist will place his elbow tip on taunt band of piriformis muscle and will apply direct pressure on it. Patient will be instructed to perform hip internal rotation, in order to achieve lengthening of the muscle. This will be repeated 5-7 times. The total duration of this session will be 40-50 minutes. Intervention 2: Intervention group B (Myofascial Release Technique) 22 Patients in Group B will receive myofascial release technique (MRT) and conventional treatment in form of hot pack for 10-15 minutes over the hip region followed by piriformis muscle stretch comprising of 3 sets with 30 seconds hold of each set. For application of Myofascial release technique patient will be instructed to sit on top of foam roller that will be placed beneath the hip of affected side. Patient will be advised to roll over the foam roller for 5 – 8 minutes until his pain reduces. Leg of affected limb or side will cross towards the knee of unaffected side. Each session will last for 40-50 minutes. The session will repeat twice a week, 8 sessions over 4 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Real patient is involved</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.  Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 6600141</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 6600141</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 20- 40 years
Gender: Both male and female
Deep-seated buttock pain with radiating pain, especially intolerable sitting pain.
Tenderness of the piriformis muscle.
Fair test positive</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Intermittent vascular claudication, spondylolisthesis
Past history of vertebral fracture
Past history of spinal surgery
Spinal tuberculosis
Rheumatoid Arthritis/Osteoarthritis.
Disc pathology and mechanical back pain.
Avascular necrosis of femoral head
Fracture of femur and hip joint dislocation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G57.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lesion of sciatic nerve, unspecified lower limb</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 A (active release technique) 22 patients in Group A will receive active release technique (ART) and conventional treatment in the form of hot pack for 10-15 minutes followed by piriformis muscle stretch for 10 seconds hold (3 sets of 10 repetitions) for a duration of 15 minutes. ART will be applied with patients in prone lying with knee flexed at 90°.the therapist will place his elbow tip on taunt band of piriformis muscle and will apply direct pressure on it. Patient will be instructed to perform hip internal rotation, in order to achieve lengthening of the muscle. This will be repeated 5-7 times. The total duration of this session will be 40-50 minutes</i_keyword>
      <i_keyword>Intervention group B (Myofascial Release Technique) 22 Patients in Group B will receive myofascial release technique (MRT) and conventional treatment in form of hot pack for 10-15 minutes over the hip region followed by piriformis muscle stretch comprising of 3 sets with 30 seconds hold of each set. For application of Myofascial release technique patient will be instructed to sit on top of foam roller that will be placed beneath the hip of affected side. Patient will be advised to roll over the foam roller for 5 – 8 minutes until his pain reduces. Leg of affected limb or side will cross towards the knee of unaffected side. Each session will last for 40-50 minutes. The session will repeat twice a week, 8 sessions over 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 4 weeks treatment. Method of measurement: Numeric pain rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 4 weeks of treatment. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Functional Disability. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 4 weeks of  treatment. Method of measurement: Oswestry Disability Index (ODI).</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-26</approval_date>
        <contact_name>Ethics committee of Riphah International University Faisalabad</contact_name>
        <contact_address>Riphah International University, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
