<?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>IRCT20260810070604N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-20</date_registration>
      <primary_sponsor>Riphah International University Faisalabad</primary_sponsor>
      <public_title>Integrated Pain Neuroscience Education and Motor Control Training Versus McKenzie Therapy in the Treatment of Lumbar Radiculopathy</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Bio Psychomotor Rehabilitation Integrating Pain Neuroscience Education and Motor Control Training Versus McKenzie Therapy in Lumbar Radiculopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Parallel-group, single-blinded RCT with two active intervention groups, randomly allocated in a 1:1 ratio. Both groups will receive active physiotherapy interventions, with participants  blinded to group allocation, Randomization description: Participants are randomly allocated individually into two groups (18 participants each) using computer-generated simple randomization. Group A receives PNE with Motor Control Training, while Group B receives McKenzie Theray. Allocation concealment is maintained using sequentially numbered, opaque, sealed envelopes opened after baseline assessment, Blinding description: This is a single-blinded randomized clinical trial with two active intervention groups. Only the participants will be  blinded to their group allocation and the study hypothesis. Both groups will receive physiotherapy interventions, with Group A receiving Motor Control Training with Pain Neuroscience Education and Group B receiving McKenzie Therapy. The physiotherapists and outcome assessor will not be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar radiculopathy is a clinical condition caused by irritation, inflammation or compression of a nerve root in the lumbar spine. it commonly presents with low back pain radiation into buttock and lower extremity, along with symptoms such as numbness, tingling or muscle weakness. Disc herniation and degenerative changes of the lumbar spine are common causes..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Group A will receive Pain Neuroscience Education and Motor Control Training (PNE+MCT). Patients will receive PNE and MCT for 2 weeks with five 30 to 40 minute session per week. PNE will be given for 10-15 minutes at the beginning of each session in order to lessen fear-avoidance beliefs and explain neurophysiology of pain. MCT, which concentrated on the activation as well as coordination of deep trunk muscle groups, like the transverse abdominus and multifidus will came next. Exercises will range from basic activation (breathing, drawing in the abdomen) to muscle control (heel slides. knee bent fallout) and functional exercises (bridging, bird-dog, sit-stand) within a pain-free range. Intervention 2: Intervention group 2: Group B will receive McKenzie Therapy for 2 weeks, with five sessions each week lasting 20 to 30 minutes each. Lumbar extension exercises, such as prone lying down, prone on elbows and prone press-ups will be the main emphasis of the intervention repeated motions and prolonged positions determined by directional preferance. McKenzie exercises will be performed for 10 repetitions per exercise, for 3 sets per session.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The deidentified individual participant data will not be made publicly available due to participant privacy and confidentiality considerations. Data will be retained securely by the research team and used only for the purposes specified in the approved research protocol.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Lyba Musaddiq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Faisalabad Campus</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38090</zip>
        <telephone>+92 322 6380789</telephone>
        <email>lyba.musaddiq@riphahfsd.edu.pk</email>
        <affiliation>Riphah International University Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sehar Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Faisalabad, Main Satiana Road, adjacent to Fish Farm in Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38090</zip>
        <telephone>+92 325 0677170</telephone>
        <email>seharnaz70rb@gmail.com</email>
        <affiliation>Riphah International University Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 28-50 years
Clinically diagnosed patients with lumbar radiculopathy
Both males and females were included
Participants who had a confirmed disc herniation between L4-S1 levels through MRI
Had pain for at least 3 months
Had positive SLR between 40 and 70 degrees</inclusion_criteria>
      <agemin>28 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Fracture
Trauma
Inflammatory disorder
Lumbar instability
Scoliosis
Patients with RA and other systemic diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M47.816</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spondylosis without myelopathy or radiculopathy, lumbar region</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 1: Group A will receive Pain Neuroscience Education and Motor Control Training (PNE+MCT). Patients will receive PNE and MCT for 2 weeks with five 30 to 40 minute session per week. PNE will be given for 10-15 minutes at the beginning of each session in order to lessen fear-avoidance beliefs and explain neurophysiology of pain. MCT, which concentrated on the activation as well as coordination of deep trunk muscle groups, like the transverse abdominus and multifidus will came next. Exercises will range from basic activation (breathing, drawing in the abdomen) to muscle control (heel slides. knee bent fallout) and functional exercises (bridging, bird-dog, sit-stand) within a pain-free range.</i_keyword>
      <i_keyword>Intervention group 2: Group B will receive McKenzie Therapy for 2 weeks, with five sessions each week lasting 20 to 30 minutes each. Lumbar extension exercises, such as prone lying down, prone on elbows and prone press-ups will be the main emphasis of the intervention repeated motions and prolonged positions determined by directional preferance. McKenzie exercises will be performed for 10 repetitions per exercise, for 3 sets per session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain experienced by patients with lumbar radiculopathy. Timepoint: At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks. Method of measurement: Numeric Pain Rating Scale to measure pain intensity. NPRS is a 11-point, unidimensional tool (0-10) where o indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain and 7-10 indicates severe pain.</prim_outcome>
      <prim_outcome>Level of disability and functional limitation associated with lumbar radiculopathy. Timepoint: At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks. Method of measurement: Roland Morris Disability Questionnaire (RMDQ) to measure level of disability and functional limitations where 0 indicates no disability, 1-8 indicates mild disability, 9-16  indicates moderate disability and 17-24 indicates severe disability.</prim_outcome>
      <prim_outcome>Fear of movement and hesitation associated with pain in patients with lumbar radiculopathy. Timepoint: At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks. Method of measurement: Tampa Scale of Kinesiophobia to measure fear of movement and hesitation of movement. The TSK score ranges from 17-68, with lower scores indicating less fear of movement and higher scores indicating greater fear of movement.</prim_outcome>
      <prim_outcome>Pain distribution and location of pain in patients with lumbar radiculopathy. Timepoint: At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks. Method of measurement: Michigan Body Map for distribution and location of pain and musculoskeletal symptoms across different body regions. The MBM assesses 35 body regions, with each symptomatic region receiving a score of 1 and each non-symptomation region receiving a score of 0. The total score ranges from 0-35 where a lower score indicating fewer symptomatic body regions while a higher score indicates symptoms in more body regions.</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>Academic Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-04</approval_date>
        <contact_name>Research and Ethics Committee (REC)</contact_name>
        <contact_address>Riphah International University Faisalabad Campus, Main Satayana Road (Adjacent to Fish Farm), Faisalabad, Pakistan Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
