<?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>IRCT20230607058411N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-11</date_registration>
      <primary_sponsor>The Univerity of Faisalabad</primary_sponsor>
      <public_title>Comparative effects of Post Isometric Relaxation and Positional Release therapy on Pain, Range of motion and Cadence in patient with plantar fasciitis.</public_title>
      <acronym>Comparative effects of PIR and PRT on pain, ROM and cadence in patient with plantar fasciitis</acronym>
      <scientific_title>Comparative Effects Of Post Isometric Relaxation And Positional Release Therapy On Pain, Range Of Motion And Cadence In Patient With Plantar Fasciitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: As per the inclusion and exclusion criteria of the study , patients will be divided into two groups randomly by Random lottary method.
The randomization process in this study followed a simple randomization method at the individual level. The unit of randomization was the individual participant, meaning that each participant was randomly assigned to either the PRT group or the PIR group.
To ensure balance and control for potential confounding factors, randomization strata were used. These strata may have included factors such as age, gender, or severity of Plantar Fasciitis. By stratifying the randomization process, the goal was to create comparable groups with similar characteristics to minimize the influence of potential confounders on the study outcomes.
To build the random sequence, patient divided into two groups randomly by Random lottary method. This random sequence helps to ensure that the allocation is unbiased and independent of any potential influence or bias from the researchers.
Allocation concealment, a crucial component of randomization, involves preventing the researchers from knowing the group assignment before the randomization process takes place. This ensures that the allocation is concealed and not influenced by subjective factors or biases. Techniques such as sealed envelopes or secure online systems may have been used to achieve allocation concealment, ensuring that the researchers remain unaware of the group assignment until the randomization process is completed.
By employing randomization, allocation concealment, and potentially stratified randomization, this study aimed to reduce bias and ensure the groups were comparable at baseline. These methods enhance the internal validity of the study, strengthening the validity of the comparative analysis between the PRT and PIR groups, Blinding description: The patients taking part in the study would be blinded, they would not be able to know the group they have been allocated to, either Post -Isometric Relaxation Techniques or Positional Release Therapy. Principal investigator, who is responsible for the overall conduct and supervision of the study, is also blinded in a double-blind trial. In investigator-initiated trials, the principal investigator may have a vested interest in the study outcomes. By blinding the principal investigator, the risk of conscious or unconscious bias in data interpretation and analysis is minimized.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Plantar fasciitis is a common cause of heel pain, characterized by discomfort in the plantar area of the foot, particularly the inferior part of the heel. The pain is often more severe in the morning or after periods of inactivity, and it worsens with prolonged standing or weight-bearing activities. Physiotherapy treatments, including rest, taping, stretching, orthosis, silicon heel cups, and myofascial release, are commonly used for pain relief. This study aimed to compare the effects of two physiotherapy techniques, Post Isometric Relaxation (PIR) and Positional Release Therapy (PRT), on pain, range of motion, and cadence in patients with plantar fasciitis. The results of this research will provide valuable insights into the effectiveness of these therapies in managing the symptoms of plantar fasciitis and potentially guide clinicians in selecting appropriate treatment options for their patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (PIR) subject will be in supine position keeping knee fully extended and therapist on affected side in walking position. The subject's ankle joint will be dorsiflexed until a resistance feel and will ask to hold this position and exert 20% of force towards plantar flexion for a period of 5 to 7 seconds. Resistance will be released and relaxation of 5 seconds will be given during which the ankle will was passively dorsiflexed to a new barrier. 5 repetitions will be given. Intervention 2: Intervention group: Group B (PRT) During the positional release therapy  for plantar fasciitis, the therapist places their thumb on the tender point at the insertion of the plantar fascia while the patient is in a supine position with the knee flexed on the same side. The patient then performs plantar flexion of the toes and ankle, while the therapist monitors the sore spot with their thumb, curling around the tender point until symptomatic relief is felt. If necessary, foot supination/pronation may be added. The position of ease is maintained for 90 seconds, allowing the tissues beneath the monitoring thumb to soften. Once the foot is returned to a neutral position without moving the thumb, the tender spot is re-evaluated. This process is repeated three times with 30-second resting intervals in-between each repetition.</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:
Comparative effects of Post Isometric Relaxation and Positional Release therapy on Pain, Range of motion and Cadence in patient with plantar fasciitis.
All collected identified IPD

When:
Data will be available after the completion of study and will remain available till 6 months

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator Rabia Khan gmail : rabisandhu4549@gmail.com

Where to obtain:
Rabia Khan  rabisandhu4549@gmail.com

How to obtain:
The data/document could be used by communicating with the principle investigator  Rabia Khan  rabisandhu4549@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rabia Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abdullah Colny Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>2353</zip>
        <telephone>+92 302 9129919</telephone>
        <email>rabisandhu4549@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nimra Iftkhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Raiz-ul-Jannah Fasialabad</address>
        <city>faisalabad</city>
        <country1>Pakistan</country1>
        <zip>3455</zip>
        <telephone>+92 304 6886384</telephone>
        <email>nimraiftikhar5573@gmail.com</email>
        <affiliation>The University of Fasialabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants who were willing to sign the consent form.
School teachers.
Male and female both .
Patients having unilateral or bilateral .
Windlass test positive .
Patient with moderate pain on Visual analogues scale .
Age between 30 to 60.
Plantar fascists patient present with pain that persist for more than 3 weeks.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any traumatic injury of lower limb.
Any nerve related issue of lower limb.
Patient on NSAIDS and steroids.
Patient with any other musculoskeletal disorder of hip knee foot .
Prior history of corticosteroids injections.
History of ankle or foot fracture .
Patient with congenital and acquired deformities .
Patient using assistive devices.
Subjects unwilling to participate in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M72.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Plantar fascial fibromatosis</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: Group A (PIR) subject will be in supine position keeping knee fully extended and therapist on affected side in walking position. The subject's ankle joint will be dorsiflexed until a resistance feel and will ask to hold this position and exert 20% of force towards plantar flexion for a period of 5 to 7 seconds. Resistance will be released and relaxation of 5 seconds will be given during which the ankle will was passively dorsiflexed to a new barrier. 5 repetitions will be given.</i_keyword>
      <i_keyword>Intervention group: Group B (PRT) During the positional release therapy  for plantar fasciitis, the therapist places their thumb on the tender point at the insertion of the plantar fascia while the patient is in a supine position with the knee flexed on the same side. The patient then performs plantar flexion of the toes and ankle, while the therapist monitors the sore spot with their thumb, curling around the tender point until symptomatic relief is felt. If necessary, foot supination/pronation may be added. The position of ease is maintained for 90 seconds, allowing the tissues beneath the monitoring thumb to soften. Once the foot is returned to a neutral position without moving the thumb, the tender spot is re-evaluated. This process is repeated three times with 30-second resting intervals in-between each repetition.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1.  Dorsiflexion range of motion of ankle joint. Timepoint: Goniometer for assessing the dorsiflexion ROM at baseline, 2nd, 4th, 6th &amp; 8th week. Method of measurement: Goniometry is a technique used to measure the range of motion (ROM) of joints, including the ankle joint. In the case of the ankle, a specific instrument called a goniometer is employed. To measure ankle dorsiflexion and plantar flexion, the goniometer is positioned with its stationary arm aligned with the fibula (lateral malleolus) and its movable arm aligned with the dorsum of the foot on the lateral side of the ankle joint. Plantar flexion is evaluated by pointing the toes downward, while dorsiflexion is measured by actively moving the foot toward the shin. The angles of dorsiflexion and plantar flexion are recorded in degrees. Goniometry enables the quantification of ankle joint ROM, which is valuable for diagnosing conditions, monitoring rehabilitation progress, and assessing the effectiveness of treatment interventions.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>2 measuring pain severity in patients having PF. Timepoint: Visual Analogues Scale for the assessment and measuring pain. at baseline ,  outcome will be measured 2nd ,4th,6th &amp; 8th week. Method of measurement: The Visual Analogue Scale (VAS) is a subjective technique for assessing pain in plantar fasciitis (PF). It involves using a line with anchor points to represent the extremes of pain. Patients mark a point on the line to indicate their perceived pain intensity. The VAS provides a continuous measurement of pain, facilitating comparisons of treatment outcomes and tracking changes over time. It is a valuable tool for evaluating treatment effectiveness and assessing pain levels in PF patients.</sec_outcome>
      <sec_outcome>Cadence (number of steps per minute) in patients having Plantar Fasciitis. Timepoint: Stopwatch for the assessment of cadence.  Outcome will be measured 2nd ,4th,6th &amp; 8th week. Method of measurement: A stopwatch is a timing tool used to measure the passing of time. It is also employed to assess cadence, which refers to the frequency of steps or strides taken during activities like walking or jogging. By counting the number of steps within a designated timeframe, typically a minute, a stopwatch provides a convenient method for monitoring cadence. While there are more advanced wearable devices for precise cadence measurements, a stopwatch can still provide approximate measurements when such technology is not available.</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>My parents Supporting me,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-25</approval_date>
        <contact_name>The University of Faisalabad</contact_name>
        <contact_address>Abdullah Colony Samundri road Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
