<?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>IRCT20230606058395N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-26</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparative Effects of PIR Technique and Mulligan TSLR Technique alng with Retrowalking in Knee OA</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effects of Post Isometric Relaxation Technique and Mulligan Traction Straight Leg Raise Technique Along with Retro walking on Hamstring Flexibility in Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70539</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 by double lottery method while allocating individuals in Group A and Group B equally divide, Blinding description: Double Blinding
As participant do not know about treatment or in which treatment Group, he/she was allocated. The care provider also do not know the individual group. Investigator and outcome assessor will only collect outcome of the individuals instead of knowing the group and treatment allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Baseline treatment was given to both groups A and B. Where moist heat applied for 10 minutes to the hamstrings muscles in supine position. Quadriceps isometrics by foam roller 10 rep with 5-7 hold,  then Group A was treated by (Post isometric relaxation technique). In Group A, the participants received a treatment known as the baseline treatment and Post-Isometric Relaxation (PIR) Technique. Patient Positioning: During this technique, the patient was positioned in a supine lying position, and the therapist stood on the side affected by the condition. Procedure: The involved leg's knee was gently extended, while the involved leg’s hip was flexed. Then therapist placed the patient's calf on their shoulder and positioned their hands across the upper leg, just above the knee joint. Next, the therapist passively flexed the hip of the affected leg until they encountered resistance. Isometric contraction: The patient was instructed to gently push down on the therapist's shoulder with their leg, exerting resistance against the therapist's effort to extend the hip while inhaling air by normal breathing. This created an isometric contraction, which was held for approximately 5-8 seconds, with appropriate breathing instructions provided to the patient. After the contraction, the patient was instructed to relax and do exhalation, then therapist gently flexed the whole leg at hip joint until the next point of resistance was reached. Repetition: This cycle was repeated 3 to 4 times per day, with three sessions per week on alternate days. After technique application, 2 minutes interval and then retro walking was advised to both group individuals to do at flat surface at their maximum pace for 5-10 minutes. Intervention 2: Baseline treatment was given to both groups A and B. Where moist heat applied for 10 minutes to the hamstrings muscles in supine position. Quadriceps isometrics by foam roller 10 rep with 5-7 hold,  then Group B will be treated with baseline treatment and TSLR technique involves sustained traction applied to the limb. Patient actively does the SLR and both the therapist and the patient note the range. Therapist now grasp patient lower leg proximal to the ankle joint and raise it off the bed to a position just short of the painful range. Therapist flexes his knees and holds the clasped leg to his chest. When the therapist extends his knees this will effectively apply a longitudinal traction to the leg provided the bed is low enough and the therapist is tall enough. Sustain this traction and undertake a straight leg raise as far as it will go provided there is no pain. Then pain free SLR with traction is given for 3 times, three sessions per week. After technique application, 2 minutes interval and then retro walking was advised to both group individuals to do at flat surface at their maximum pace for 5-10 minutes.</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 Ethical</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rubina Zulfiqar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sargodha road near Kia motors Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 9392994</telephone>
        <email>rubinazulfqar@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nimra Iftikhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House 42 Daewoo road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38002</zip>
        <telephone>+92 41 2698888</telephone>
        <email>nimraiftikhar@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Knee pain with crepitus sound for 6 months or more
Both genders having age 40-60
Morning stiffness lasting &lt;30 minutes
Bony tenderness with no palpable warmth
Tight Hamstrings muscles
Numeric Pain Rate Scale (NPRS) score of 5 or greater than 5
Radiographic finding Grade II-III according to Kellgren Lawrence Scale
Bilateral or Unilateral Involvement</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any history of trauma to the knee ligament or any neurological impairment
Any other pathology (e.g. fractures, bursitis, backache, radiating pain to the leg)
History of recent steroid injection since 3 months
Severe valgus or varus deformity
History of recent lower limb or spinal surgeries
Signs of active infection or inflammation to the knee joint
Participants who are unwilling to participate in study</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Baseline treatment was given to both groups A and B. Where moist heat applied for 10 minutes to the hamstrings muscles in supine position. Quadriceps isometrics by foam roller 10 rep with 5-7 hold,  then Group A was treated by (Post isometric relaxation technique). In Group A, the participants received a treatment known as the baseline treatment and Post-Isometric Relaxation (PIR) Technique. Patient Positioning: During this technique, the patient was positioned in a supine lying position, and the therapist stood on the side affected by the condition. Procedure: The involved leg's knee was gently extended, while the involved leg’s hip was flexed. Then therapist placed the patient's calf on their shoulder and positioned their hands across the upper leg, just above the knee joint. Next, the therapist passively flexed the hip of the affected leg until they encountered resistance. Isometric contraction: The patient was instructed to gently push down on the therapist's shoulder with their leg, exerting resistance against the therapist's effort to extend the hip while inhaling air by normal breathing. This created an isometric contraction, which was held for approximately 5-8 seconds, with appropriate breathing instructions provided to the patient. After the contraction, the patient was instructed to relax and do exhalation, then therapist gently flexed the whole leg at hip joint until the next point of resistance was reached. Repetition: This cycle was repeated 3 to 4 times per day, with three sessions per week on alternate days. After technique application, 2 minutes interval and then retro walking was advised to both group individuals to do at flat surface at their maximum pace for 5-10 minutes.</i_keyword>
      <i_keyword>Baseline treatment was given to both groups A and B. Where moist heat applied for 10 minutes to the hamstrings muscles in supine position. Quadriceps isometrics by foam roller 10 rep with 5-7 hold,  then Group B will be treated with baseline treatment and TSLR technique involves sustained traction applied to the limb. Patient actively does the SLR and both the therapist and the patient note the range. Therapist now grasp patient lower leg proximal to the ankle joint and raise it off the bed to a position just short of the painful range. Therapist flexes his knees and holds the clasped leg to his chest. When the therapist extends his knees this will effectively apply a longitudinal traction to the leg provided the bed is low enough and the therapist is tall enough. Sustain this traction and undertake a straight leg raise as far as it will go provided there is no pain. Then pain free SLR with traction is given for 3 times, three sessions per week. After technique application, 2 minutes interval and then retro walking was advised to both group individuals to do at flat surface at their maximum pace for 5-10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee Pain. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Numeric Pain Rate Scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Universal Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Ability. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: WOMAC Questionnare.</sec_outcome>
      <sec_outcome>Cadence. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Pedometer.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-25</approval_date>
        <contact_name>The University of Faisalabad</contact_name>
        <contact_address>Street 5, Madan pura Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
