<?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>IRCT20241125063847N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-19</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Dry Needling in Addition to conventional Physical Therapy in Patients with Piriformis Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Dry Needling in Addition to conventional Physical Therapy in Patients with Piriformis Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81719</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Lottery method will be used for randomization by an independent statistician. Randomization will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis. In this method Group names will be mentioned on separate slips of paper of same size, shape and color. They are folded and mixed up in a container. A blind fold selection will be made and each member of the population will be assigned a number. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by a researcher after baseline testing. Outcome assessors will be unaware of group assignment, Blinding description: This is single blinded study in which accessor will be kept blind  who will not involve in patient recruitment or assessment or data analysis.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Piriformis syndrome is a neuromuscular condition that occurs when the piriformis muscle , located in the buttock region , compresses the sciatic nerve. This can cause pain, numbness , and down the leg , often mimicking symptoms of sciatica.</hc_freetext>
      <i_freetext>Intervention 1: Dry Needling: Participants of Group A was received dry needling (DN). Acupuncture was applied to the trigger points, as described in previous studies by Itoh et al. Tight points or taut band was identified by palpation. The patient was laying on the abdomen. The examiner found the landmarks of greater trochanter and sacrum in S2, S3 and S4. He was inserted the needle vertically to the surface of trochanter, from the sciatic notch toward the pubis symphysis, directly to the stiffness points. Dry needling was performed deeply by a needle with the. 30mm in diameter and 65mm in length. Duration of needling in piriformis muscle was one minute. After the application of DN, mild stretching of piriformis was performed. This group was received dry needling at the end of 1st, 3rd and 5th sessions. Hip Abductor Strengthening: Subject’s position was in side- lying with the affected side upward. Lower leg flexed at hip &amp; knee. Pelvis was stabilized by therapist and upper leg kept out of couch at the level of ankle. One end of the elastic band was tied to the distal part of the affected leg while the other end tied around. The leg of that couch, keeping the elastic band perpendicular to the floor. Subjects were instructed to lift the upper leg towards the ceiling against the force of the resistance band. This strengthening exercise was performed 3 sets; 10 times per set. Sciatic Nerve Mobilization (Tensioning Technique): Sciatic nerve mobilization was given for 12-15 sessions including 30 sec hold and 1 min rest. The subjects were in supine lying position and straight leg raise was done for inducing longitudinal tension as the sciatic nerve runs posterior to hip and knee Joints while maintaining extension at the Knee. In order to induce Dural motion through the sciatic nerve; the leg was raised. At least past 35 degrees in order to take up Slack in the nerve. To introduce additional Traction (i.e., sensitization) into the proximal aspect of the sciatic nerve, hip adduction was added to the straight leg raise. The nerve sliding technique was applied for 20-30 repetitions in 2-3 sets per day, and the nerve tensioning technique was implemented in addition for 15-25 seconds in 5-7 repetitions.Piriformis Stretching: In supine lying position subject’s tested leg was placed into flexion at the hip and knee so that the foot rests on the table lateral to the contra-lateral knee (the tested leg is crossed over the straight non-tested Leg). The non-tested side pelvis was stabilized during the test and the knee of the tested side was pushed into adduction, to place a stretch on piriformis. Holding time was 20seconds, with 5 seconds rest period and repeated for 5 times. Intervention 2: Intervention group: In Group B all allocated participants received conventional therapy. Conventional therapy includes 15 minutes of heat therapy. All the patients of this group was treated by hip abductor muscle strengthening along with sciatic Nerve mobilization &amp; piriformis stretching. Three sets of hip abductor muscle strengthening exercises with 10 sec hold for 10 repetitions were done 3 days per week for 2 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographics data and data related to final outcome will be shared by maintaining the confidentially

When:
Data will be available after the publication of findings till six months

To whom:
Ghanwa Noor

Conditions:
For research purpose

Where to obtain:
To the corresponding author of the study, Ghanwa Noor and cane contact on +92 332 1877045  and Drnoo045@gmail.com

How to obtain:
Open access and there is the traditional public data release where anyone can get access to the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghanwa Noor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 332 1877045</telephone>
        <email>Drnoor045@gmail.com</email>
        <affiliation>The university of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghanwa Noor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 332 1877045</telephone>
        <email>Drnoor045@gmail.com</email>
        <affiliation>The university of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 30-50 years
•	Both Male and females
•	Patients with positive FAIR &amp; Lasegue test
•	Having atleast 4 score of Numeric Pain Rating Scale</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Patients with any abnormality in spine column
•	Patients with any systemic inflammatory disease (rheumatologic Conditions)
•	Recent fracture/dislocation in and around the Hip Joint
•	Patient with psychological impairment (Parkinson's disease)
•	Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.838</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other muscle spasm</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Dry Needling: Participants of Group A was received dry needling (DN). Acupuncture was applied to the trigger points, as described in previous studies by Itoh et al. Tight points or taut band was identified by palpation. The patient was laying on the abdomen. The examiner found the landmarks of greater trochanter and sacrum in S2, S3 and S4. He was inserted the needle vertically to the surface of trochanter, from the sciatic notch toward the pubis symphysis, directly to the stiffness points. Dry needling was performed deeply by a needle with the. 30mm in diameter and 65mm in length. Duration of needling in piriformis muscle was one minute. After the application of DN, mild stretching of piriformis was performed. This group was received dry needling at the end of 1st, 3rd and 5th sessions. Hip Abductor Strengthening: Subject’s position was in side- lying with the affected side upward. Lower leg flexed at hip &amp; knee. Pelvis was stabilized by therapist and upper leg kept out of couch at the level of ankle. One end of the elastic band was tied to the distal part of the affected leg while the other end tied around. The leg of that couch, keeping the elastic band perpendicular to the floor. Subjects were instructed to lift the upper leg towards the ceiling against the force of the resistance band. This strengthening exercise was performed 3 sets; 10 times per set. Sciatic Nerve Mobilization (Tensioning Technique): Sciatic nerve mobilization was given for 12-15 sessions including 30 sec hold and 1 min rest. The subjects were in supine lying position and straight leg raise was done for inducing longitudinal tension as the sciatic nerve runs posterior to hip and knee Joints while maintaining extension at the Knee. In order to induce Dural motion through the sciatic nerve; the leg was raised. At least past 35 degrees in order to take up Slack in the nerve. To introduce additional Traction (i.e., sensitization) into the proximal aspect of the sciatic nerve, hip adduction was added to the straight leg raise. The nerve sliding technique was applied for 20-30 repetitions in 2-3 sets per day, and the nerve tensioning technique was implemented in addition for 15-25 seconds in 5-7 repetitions.Piriformis Stretching: In supine lying position subject’s tested leg was placed into flexion at the hip and knee so that the foot rests on the table lateral to the contra-lateral knee (the tested leg is crossed over the straight non-tested Leg). The non-tested side pelvis was stabilized during the test and the knee of the tested side was pushed into adduction, to place a stretch on piriformis. Holding time was 20seconds, with 5 seconds rest period and repeated for 5 times.</i_keyword>
      <i_keyword>Intervention group: In Group B all allocated participants received conventional therapy. Conventional therapy includes 15 minutes of heat therapy. All the patients of this group was treated by hip abductor muscle strengthening along with sciatic Nerve mobilization &amp; piriformis stretching. Three sets of hip abductor muscle strengthening exercises with 10 sec hold for 10 repetitions were done 3 days per week for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Numeric pain rating scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS takes &lt;1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Timepoint: 2nd week. Method of measurement: The Numeric pain rating scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS takes &lt;1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity.</prim_outcome>
      <prim_outcome>The Lower Extremity Functional Scale (LEFS) is a valid patient-rated outcome measure (PROM) used to assess lower extremity function. It was initially developed by Binkley et al. (1999) for patients with various musculoskeletal conditions. Timepoint: 2nd week. Method of measurement: This self-report questionnaire asks patients about their ability to perform twenty everyday activities, with five response options ranging from “Extreme Difficulty or Unable to Perform Activity” to “No Difficulty.” Patients’ scores are totaled, with a maximum score of 80 points indicating high function and a minimum score of 0 points indicating low function.</prim_outcome>
      <prim_outcome>The term 'goniometry' is derived from the Greek words 'gonia' meaning angle and 'metron' meaning measure, therefore goniometry refers to the measurement of angles, which in rehabilitation settings refers to the measurement of angles in each plane at the joints of the body. T. Timepoint: 2nd week. Method of measurement: he neutral zero method (0 to 180- degree system) is the most widely used method. The range of motion of each joint should be measured in isolation, to avoid trick movement (simultaneous movement of another joint) and muscle insufficiency which may alter the reading.</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>None</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-05</approval_date>
        <contact_name>Research Ethics Committee of University of Lahore</contact_name>
        <contact_address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
