<?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>IRCT20260529069564N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-20</date_registration>
      <primary_sponsor>Gujranwala Institute of Medical and Emerging Sciences (GIMES)</primary_sponsor>
      <public_title>Comparison of Strain Counterstain and Active Release Technique for Treating Plantar Fasciitis in Nursing Staff of Gujranwala: A Randomized Controlled Trial</public_title>
      <acronym>SCART-PF Trial (Strain Counterstrain vs Active Release Technique for Plantar Fasciitis)</acronym>
      <scientific_title>Comparative Effects of Strain Counterstain Verses Active Release Technique on Nursing Staff of Gujranwala with Plantar Fasciitis: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/92266</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Number of Groups (Arms): 2 groups. Allocation Ratio: 1:1. Sampling / Recruitment Technique: Non-probability convenience sampling. Study Setting: Multi-center hospital recruitment across Gujranwala (Chatha Hospital, District Headquarters Hospital, Cheema Heart Complex, and Chaudhary Hospital). Intervention Duration: 6 weeks total, 3 sessions per week, each session preceded by 12 minutes of standard physical therapy. Assessment Timepoints: Baseline, 2nd week, 4th week, 6th week, and an 8th-week follow-up assessment to evaluate retention of treatment effects, Randomization description: Method of Randomization: Simple randomization was used to allocate participants in a fixed 1:1 ratio, giving each participant an equal probability of assignment to either treatment arm. Unit of Randomization: The individual participant (nursing staff formally diagnosed with plantar fasciitis). Cluster or group-based randomization was not used. Randomization Strata: Not applicable — no pre-enrollment stratification (e.g., by gender or age band) was performed. Tools Used in Randomization: The online tool available at random.org/lists/ was used to generate the allocation sequence by specifying the total number of participants, participants per group, and group numbers, with unique identification numbers generated for each participant. How the Random Sequence was Built: The electronically generated sequence dictated whether an enrolling individual entered Group A (Strain Counterstain) or Group B (Active Release Technique). Allocation Concealment: Yes. The generated allocation sequence was concealed from participants and from the assessors performing outcome measurements; only research team members handling enrollment logistics had access to the sequence, Blinding description: Participants: Participants were blinded to group allocation and were not informed whether they were receiving Strain Counterstain or Active Release Technique. 
Outcome Assessors: Assessors recording NPRS, FAAM, and goniometric ROM at each time point were kept unaware of group allocation to minimize measurement bias. 
Treating Physiotherapists: Blinding of the treating physiotherapists was not feasible, as they were required to know the assigned technique in order to deliver the intervention correctly. 
Principal Investigators and Data Analysts: The principal investigators and statisticians responsible for data analysis had access to allocation information and were therefore not blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis — a degenerative/inflammatory condition of the plantar fascia causing pain and tenderness under the heel, sometimes extending into the arch, commonly occurring in nursing staff due to prolonged standing, walking, and heavy occupational workload..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. Intervention 2: Intervention 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The study will share a de-identified dataset containing demographic information (age, gender, BMI, affected side, symptom duration) and outcome measures (NPRS, FAAM, and ankle ROM for dorsiflexion, plantarflexion, inversion, and eversion) across all five assessment time points. The study protocol detailing methodology, interventions, and analysis procedures will also be available. Blank informed consent forms and assessment tools used in the study (NPRS, FAAM, goniometer recording sheet) will be shared upon request. Statistical analysis outputs (SPSS v27 outputs for the Mann-Whitney, Friedman, and post-hoc Wilcoxon analyses) may be provided for verification purposes. All shared data will be anonymized to protect participant confidentiality. Documents will be made available electronically upon reasonable request to the research team.

When:
The Individual Participant Data (IPD) dataset, Study Protocol, and Statistical Analysis Plan (SAP) will become available to qualified researchers beginning six months after the official publication of the final summary data results. This data will remain accessible for a period of up to three years from the initial start date of availability.

To whom:
The de-identified Individual Participant Data (IPD) and supporting clinical trial documents will be made available strictly to qualified academic researchers, physical therapy clinicians, and medical investigators affiliated with recognized academic institutions, universities, or healthcare organizations. Access will not be extended to commercial businesses, industry corporations, or entities seeking the data for commercial profit. All applicants must submit a methodologically sound research proposal demonstrating that the dataset will be utilized solely to achieve the scientific objectives specified in their approved study protocol.

Conditions:
The de-identified Individual Participant Data (IPD) and clinical trial documents will be shared strictly for academic research, scientific verification, or secondary meta-analyses. Data will be securely transmitted electronically in spreadsheet formats once the applicant signs a formal Data Use Agreement prohibiting any participant re-identification. Requests will be evaluated by an internal Scientific Review Committee based on the methodological soundness and scientific validity of the proposed research protocol.

Where to obtain:
The Individual Participant Data (IPD) dataset, clinical trial protocol, and Statistical Analysis Plan (SAP) are obtainable directly from the study's supervisory committee and principal investigators at the executing academic institution. 
The preferred mode of communication for data requests is via formal electronic mail.
Contact Person / Supervisor: Dr. Mubeen Arshad and Dr. Hassan Fayyaz Butt
Affiliated Department: Department of Physical Therapy
Institutional Mailing Address: Gujranwala Institute of Medical and Emerging Sciences (GIMES), Ali Pur Chatha Road, Near Gujranwala Medical College, Gujranwala, Punjab, Pakistan
Primary Email Address: principal@gimes.com.pk, Telephone / Contact Number: +92 321 1119104.

How to obtain:
Interested researchers should submit a written request describing the study objectives, methodology, and intended use of the data. Requests will be reviewed by the principal investigator and research team within approximately 2–4 weeks. Upon approval and completion of any required data-sharing agreement, the requested documents and de-identified dataset will be provided electronically.

Comments:
No personally identifiable participant information will be shared. Data will be provided in accordance with ethical approval requirements, participant confidentiality protections, and applicable institutional policies.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mubeen Arshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Pur Chatha Road, Near Gujranwala Medical College</address>
        <city>Gujranwala</city>
        <country1>Pakistan</country1>
        <zip>52250</zip>
        <telephone>0092-3216205421 (Admin)</telephone>
        <email>mubeenarshad1999@gmail.com</email>
        <affiliation>Gujranwala Institute of Medical and Emerging Sciences (GIMES)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Fayyaz Butt</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Pur Chatha Road, Near Gujranwala Medical College</address>
        <city>Gujranwala</city>
        <country1>Pakistan</country1>
        <zip>52250</zip>
        <telephone>+92 321 6205421</telephone>
        <email>gimespk@gmail.com</email>
        <affiliation>Gujranwala Institute of Medical and Emerging Sciences (GIMES)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Demographics: Male and female hospital nursing staff aged 25 to 60 years.
Clinical Presentation: Unilateral or bilateral pain and tenderness on the sole of the foot under the heel, sometimes extending into the arch, present for more than 4 weeks.
Symptom Pattern: Reported pain with the first step after prolonged immobilization or the first step out of bed in the morning.
Palpation Finding: Pain elicited on palpation of the medial calcaneal tubercle, persisting for longer than 4 weeks.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Co-existing Pathology: Achilles tendinopathy, tarsal tunnel syndrome, or any other foot/ankle pathology.
Systemic/Structural History: History of malignancy, lower-limb injury, or atrophy of the heel fat pad.
Structural Abnormality: Leg length discrepancy, club foot deformity, or effusion around the ankle joint.
Surgical History: Recent surgical history of the foot or leg.
Prior Treatment: Any previous history of corticosteroid injection in the heel, or current use of an assistive device for walking.</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:</i_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Measured at Baseline (Week 0), Week 2, Week 4, Week 6, and Follow-up (Week 8). Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Functional Ability of the Foot and Ankle. Timepoint: Measured at Baseline (Week 0), Week 2, Week 4, Week 6, and Follow-up (Week 8). Method of measurement: Foot and Ankle Ability Measure (FAAM).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ankle Range of Motion (dorsiflexion, plantarflexion, inversion, and eversion). Timepoint: Measured at Baseline (Week 0), Week 2, Week 4, Week 6, and Follow-up (Week 8). Method of measurement: Universal Goniometer.</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>Gujranwala Institute of Medical and Emerging Sciences (GIMES)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-18</approval_date>
        <contact_name>Ethical Committee of Gujranwala Institute of Medical and Emerging Sciences (GIMES)</contact_name>
        <contact_address>Main Campus: Ali Pur Chatha Road (near Gujranwala Medical College) Gujranwala Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
