<?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>IRCT20230216057434N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-02</date_registration>
      <primary_sponsor>Riphah International University, Faisalabad</primary_sponsor>
      <public_title>Effectiveness of two manual therapy technique in piriformis syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effectiveness of Positional Release Technique and Myofascial release technique with Foam Roller on Pain, ROM, Functional mobility and Quality of life in patients with piriformis syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75868</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 software Version 2. The total sample size will be entered with required number of participants to be allocated in two groups. An automated randomization list will be achieved with attrition rate included.
The program starts running with the default settings. Users may run the program with the default settings or set the number of groups, the name of participants in each group and the sample size. Clicking the 'Generate' button produces the random sequence. Before generating the random sequence, the option window will be displayed and different randomization settings can be entered, 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 receive.
Patients will also be blinded about the type of intervention they will received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Piriformis syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A (Positional release technique)22 patients will receive TENS and hot pack for 15 minutes on gluteal region as conservative treatment in prone lying position before the application of the Positional Release Technique (PRT) that uses Speicher's protocol. In this protocol, patients will be in prone position with their hip flexed at 60 to 90 degrees and abducted. The affected leg will hang off the table, with the bent knee resting on the thigh of the therapist. To locate the piriformis muscle, the therapist will use one hand to feel for the coccyx and the other hand to locate the greater trochanter. The trigger point will then palpate in the belly of the piriformis muscle, roughly halfway between the base of the sacrum and the greater trochanter. Once the most significant tender point is identified, the therapist will use one hand to apply gentle, sustained pressure with their fingertips directly on the trigger point for two minutes, or until the patient reports a significant reduction in pain. The therapist's other hand will adjust the patients hip position, depending on the trigger point location, to maintain the position of least discomfort. This process will be repeated throughout the PRT treatment sessions until the patient experiences a significant reduction or complete elimination of pain. Three repetitions of PRT will be performed for a period of 10 minutes at two sessions a week for 4 weeks. The total duration of treatment session will be 30-35 minutes. Furthermore, the stretching of piriformis, hamstring and calf muscles will be carried out by the therapist after the administration of PRT..For piriformis stretching, patients will be in supine position with both knees flexed at 90 degrees. The foot of the unaffected leg resting on a table with the ankle of the involved leg placed on the opposite knee. Then patients will gently pull the unaffected thigh towards their chest until a stretch is perceived in the buttock and along the lateral aspect of the hip on the affected leg. This stretch will be maintained for 60 seconds before gradually returning to the initial position. For hamstring and calf stretching, patients will be instructed to stand upright and lean forward, placing the palms of both hands on the wall. They will stretch the hamstring and calf muscles of the affected lower limb by positioning the foot of the affected limb behind and the foot of the unaffected limb in front, with both knees fully extended. As the heels of both lower limbs reach the floor, the knee of the unaffected limb will be flexed forward toward the wall to increase the stretch on the soleus of the affected limb. The upper body will then be swung left and right to ensure the stretching of the entire hamstring muscle group. Intervention 2: Intervention group Group B (myofascial release technique with foam roller): 22 patients will receive TENS and hot pack for 15 minutes on gluteal region as conservative treatment in prone position before the application of myofascial release technique with foam roller. In this technique, patients will be instructed to position themselves on the floor in a long sitting position, bending the hip and knee with the foot that placed on the floor. Then they will place the moderate density foam roller under their hip with the knee straight for the intervention. After that, patients will initiate their own roller massage technique for 2 minutes. Session duration will be 30-35 minutes, twice a week and there will be 8 sessions over 4 weeks. Furthermore, the stretching of piriformis, hamstring and calf muscles will be carried out by the therapist after the administration of MRT with foam roller. For piriformis stretching, patients will be in supine position with both knees flexed at 90 degrees. The foot of the unaffected leg resting on a table with the ankle of the involved leg placed on the opposite knee. Then patients will gently pull the unaffected thigh towards their chest until a stretch is perceived in the buttock and along the lateral aspect of the hip on the affected leg. This stretch will be maintained for 60 seconds before gradually returning to the initial position. For hamstring and calf stretching, patients will be instructed to stand upright and lean forward, placing the palms of both hands on the wall. They will stretch the hamstring and calf muscles of the affected lower limb by positioning the foot of the affected limb behind and the foot of the unaffected limb in front, with both knees fully extended. As the heels of both lower limbs reach the floor, the knee of the unaffected limb will be flexed forward toward the wall to increase the stretch on the soleus of the affected limb. The upper body will then be swung left and right to ensure the stretching of the entire hamstring muscle group.</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>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>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>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female patients.
Age group 25-40 years.
A score of 8 or more than 8 out of 12 scoring system according to Clinical scoring system for the diagnosis of piriformis muscle syndrome</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mentally retarded
Any pathology or recent injury near the hip, sacroiliac joint, or lumbar spine
Limb length discrepancy
Recent buttock trauma and bladder/bowel dysfunction
Ischiogluteal/ischiofemoral bursitis or impingement
Referred pain from gastrointestinal or pelvic sources ( in particular colon cancer, endometriosis and interstitial cystitis)</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 (Positional release technique)22 patients will receive TENS and hot pack for 15 minutes on gluteal region as conservative treatment in prone lying position before the application of the Positional Release Technique (PRT) that uses Speicher's protocol. In this protocol, patients will be in prone position with their hip flexed at 60 to 90 degrees and abducted. The affected leg will hang off the table, with the bent knee resting on the thigh of the therapist. To locate the piriformis muscle, the therapist will use one hand to feel for the coccyx and the other hand to locate the greater trochanter. The trigger point will then palpate in the belly of the piriformis muscle, roughly halfway between the base of the sacrum and the greater trochanter. Once the most significant tender point is identified, the therapist will use one hand to apply gentle, sustained pressure with their fingertips directly on the trigger point for two minutes, or until the patient reports a significant reduction in pain. The therapist's other hand will adjust the patients hip position, depending on the trigger point location, to maintain the position of least discomfort. This process will be repeated throughout the PRT treatment sessions until the patient experiences a significant reduction or complete elimination of pain. Three repetitions of PRT will be performed for a period of 10 minutes at two sessions a week for 4 weeks. The total duration of treatment session will be 30-35 minutes. Furthermore, the stretching of piriformis, hamstring and calf muscles will be carried out by the therapist after the administration of PRT..For piriformis stretching, patients will be in supine position with both knees flexed at 90 degrees. The foot of the unaffected leg resting on a table with the ankle of the involved leg placed on the opposite knee. Then patients will gently pull the unaffected thigh towards their chest until a stretch is perceived in the buttock and along the lateral aspect of the hip on the affected leg. This stretch will be maintained for 60 seconds before gradually returning to the initial position. For hamstring and calf stretching, patients will be instructed to stand upright and lean forward, placing the palms of both hands on the wall. They will stretch the hamstring and calf muscles of the affected lower limb by positioning the foot of the affected limb behind and the foot of the unaffected limb in front, with both knees fully extended. As the heels of both lower limbs reach the floor, the knee of the unaffected limb will be flexed forward toward the wall to increase the stretch on the soleus of the affected limb. The upper body will then be swung left and right to ensure the stretching of the entire hamstring muscle group.</i_keyword>
      <i_keyword>Intervention group Group B (myofascial release technique with foam roller): 22 patients will receive TENS and hot pack for 15 minutes on gluteal region as conservative treatment in prone position before the application of myofascial release technique with foam roller. In this technique, patients will be instructed to position themselves on the floor in a long sitting position, bending the hip and knee with the foot that placed on the floor. Then they will place the moderate density foam roller under their hip with the knee straight for the intervention. After that, patients will initiate their own roller massage technique for 2 minutes. Session duration will be 30-35 minutes, twice a week and there will be 8 sessions over 4 weeks. Furthermore, the stretching of piriformis, hamstring and calf muscles will be carried out by the therapist after the administration of MRT with foam roller. For piriformis stretching, patients will be in supine position with both knees flexed at 90 degrees. The foot of the unaffected leg resting on a table with the ankle of the involved leg placed on the opposite knee. Then patients will gently pull the unaffected thigh towards their chest until a stretch is perceived in the buttock and along the lateral aspect of the hip on the affected leg. This stretch will be maintained for 60 seconds before gradually returning to the initial position. For hamstring and calf stretching, patients will be instructed to stand upright and lean forward, placing the palms of both hands on the wall. They will stretch the hamstring and calf muscles of the affected lower limb by positioning the foot of the affected limb behind and the foot of the unaffected limb in front, with both knees fully extended. As the heels of both lower limbs reach the floor, the knee of the unaffected limb will be flexed forward toward the wall to increase the stretch on the soleus of the affected limb. The upper body will then be swung left and right to ensure the stretching of the entire hamstring muscle group.</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 treatment. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Functional mobility. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 4 weeks treatment. Method of measurement: Time up and go test.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 4 weeks treatment. Method of measurement: Sf-36.</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>2024-03-01</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>
