<?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>IRCT20230907059376N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-24</date_registration>
      <primary_sponsor>Khyber Medical University, Peshawar</primary_sponsor>
      <public_title>Effects of Proprioceptive neuromuscular facilitation stretching vs joint mobilization for improving joint mobility and quality of life in patients with knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Proprioceptive neuromuscular facilitation stretching vs joint mobilization for improving joint mobility and quality of life in patients with knee osteoarthritis.  A randomize controlled trail</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82547</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to either the PNF Stretching (Group A) or Joint Mobilization (Group B) using the sealed envelope method to ensure unbiased allocation. Each eligible participant will draw a sealed envelope containing their group assignment. An independent researcher will oversee the randomization process, while the outcome assessor will remain blinded to group allocation. This method minimizes selection bias and ensures equal distribution of participants across both intervention groups, Blinding description: The outcome assessor will be **blinded** to group allocation to minimize bias in data collection and analysis. They will not be informed of participants’ assigned interventions and will only assess outcomes based on pre- and post-intervention measurements. This ensures objective evaluation of joint mobility and quality of life improvements.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the experimental group will undergo Proprioceptive Neuromuscular Facilitation (PNF) stretching focusing on the knee flexors and extensors. The intervention will follow a hold-relax technique, where targeted muscles will be actively contracted for 5–10 seconds, followed by a passive stretch. The intensity of stretching will gradually increase over four weeks, with longer hold durations and integration with functional movements such as sit-to-stand and step-ups. Sessions will be conducted three times per week for four weeks, with each session lasting 30–45 minutes. Both interventions will be preceded by a 5–10 minute warm-up and followed by a cool-down period to enhance treatment effectiveness and prevent injury. Intervention 2: Control group: Participants in the control group will receive joint mobilization therapy using Maitland mobilization techniques (Grade III-IV). This intervention includes anterior-posterior (AP) glides and patellar mobilization, aimed at reducing joint stiffness, improving synovial fluid movement, and enhancing knee joint mobility. The sessions will be conducted three times per week for four weeks, with each session lasting 30–45 minutes. Mobilization intensity will progress over time, incorporating weight-bearing joint mobilization and sustained holds in later 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:
The shared data will be shared with the title "Effects of Proprioceptive neuromuscular facilitation stretching vs. Joint Mobilization for Improving Joint Mobility and Quality of Life in Patients with Knee Osteoarthritis: A Randomized Controlled Trial" which will include only primary outcome data i.e. range of motion for all the participants included in the study and completed the program.

When:
The data will be made available six months after the publication of study results and will remain accessible for a period of five years.

To whom:
Deidentified data will be available to researchers affiliated with academic institutions, healthcare organizations, and policymakers conducting relevant research. Industry professionals may request access with justification.

Conditions:
Access will be granted for scientific research, systematic reviews, and meta-analyses related to physiotherapy, osteoarthritis management, and rehabilitation. All requests will be reviewed by an independent data-sharing committee, ensuring appropriate use aligned with ethical guidelines.

Where to obtain:
Requests for access should be submitted via email to the principal investigator or through the institutional research office at Khyber Medical University (KMU), Institute of Physical Medicine &amp; Rehabilitation (IPM&amp;R).
ipmr@kmu.edu.pk

How to obtain:
Interested researchers must submit a formal data access request, including their research objectives, ethical approval (if applicable), and data security measures. The review process may take 4–6 weeks, and approved applicants must sign a data-sharing agreement ensuring compliance with confidentiality and ethical standards.

Comments:
All shared data will comply with ethical, legal, and institutional guidelines to protect participant confidentiality. Any modifications to the data-sharing plan will be communicated through relevant academic channels.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sarmad Khattak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No. 245 Street 7 Sector N 2 Phase 4 Hayatabad Peshawar</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 5838666</telephone>
        <email>sarmadkhattak007@gmail.com</email>
        <affiliation>Rehman Medical Institute, Peshawar</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sarmad Khattak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No. 245 Street 7 Sector N 2 Phase 4 Hayatabad Peshawar</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 5838666</telephone>
        <email>sarmadkhattak007@gmail.com</email>
        <affiliation>Rehman Medical Institute, Peshawar</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals aged between 40 to 75 years diagnosed with knee osteoarthritis based on clinical and radiographic criteria
Patients experiencing moderate to severe knee pain with functional limitations for at least six months.
Participants with a Kellgren-Lawrence grade II–III classification of knee OA.
Individuals who have not received intra-articular steroid injections or undergone knee surgery in the past six months.
Patients who are willing to participate in the study and provide informed consent.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>OA patients who have received intra articular injections.
Those with neurological disorders affecting lower limb function.
Participants currently undergoing any other physiotherapy interventions targeting knee OA.
Patients with severe knee deformities (varus/valgus) impacting normal movement mechanics.
Individuals with a history of recent fractures, infections, or malignancy involving the knee joint.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unilateral primary osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the experimental group will undergo Proprioceptive Neuromuscular Facilitation (PNF) stretching focusing on the knee flexors and extensors. The intervention will follow a hold-relax technique, where targeted muscles will be actively contracted for 5–10 seconds, followed by a passive stretch. The intensity of stretching will gradually increase over four weeks, with longer hold durations and integration with functional movements such as sit-to-stand and step-ups. Sessions will be conducted three times per week for four weeks, with each session lasting 30–45 minutes. Both interventions will be preceded by a 5–10 minute warm-up and followed by a cool-down period to enhance treatment effectiveness and prevent injury</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive joint mobilization therapy using Maitland mobilization techniques (Grade III-IV). This intervention includes anterior-posterior (AP) glides and patellar mobilization, aimed at reducing joint stiffness, improving synovial fluid movement, and enhancing knee joint mobility. The sessions will be conducted three times per week for four weeks, with each session lasting 30–45 minutes. Mobilization intensity will progress over time, incorporating weight-bearing joint mobilization and sustained holds in later weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variables are joint mobility in patients with knee osteoarthritis. Timepoint: Assessments will be conducted at baseline (pre-intervention) and after four weeks (post-intervention) following the final treatment session. The outcome assessor, who is blinded to group allocation, will perform all measurements to ensure objectivity. Method of measurement: Joint mobility will be measured using a goniometer to assess knee range of motion (ROM).</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>Khyber Medical University, Peshawar</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-19</approval_date>
        <contact_name>KMU AS&amp;RB</contact_name>
        <contact_address>5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa Peshawar Khyber Pakhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
