<?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>IRCT20230614058479N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-23</date_registration>
      <primary_sponsor>The university of Faisalabad</primary_sponsor>
      <public_title>Effect of pain neuroscience education PNE and physical exercise for patients with lumbar radiculopathy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of pain neuroscience education and physical exercise for patients with lumbar radiculopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70681</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: the non probability convenience sampling technique.(random allocation by computer generative Lottery method), Patients divided into two groups one is interventional group while other is control group, Blinding description: participants are blinded during the trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar Radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: this group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise (PE) performed session;  3 sessions per week which are consisting on Warm-up, slow and deep breathing exercise for about 3 minutes to relax the patient, then activation and join mobility exercises, balance and agility exercises, strength exercises and resistance training (in includes ankle pump, heel slide, Straight leg raise, Bridging and modified bridging with leg raise, 4 point kneeling, and kneeling with arm and leg lift) hold all positions for 5 to 10 seconds with 10 repetitions starts moderate exercises that was gradually increased. Each exercises session was completed in 35-45 minutes and then cool down phase including with relaxation exercises for 10-15 minutes. Intervention 2: Intervention group: this group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise (PE) performed session;  3 sessions per week which are consisting on Warm-up, slow and deep breathing exercise for about 3 minutes to relax the patient, then activation and join mobility exercises, balance and agility exercises, strength exercises and resistance training (in includes ankle pump, heel slide, Straight leg raise, Bridging and modified bridging with leg raise, 4 point kneeling, and kneeling with arm and leg lift) hold all positions for 5 to 10 seconds with 10 repetitions starts moderate exercises that was gradually increased. Each exercises session was completed in 35-45 minutes and then cool down phase including with relaxation exercises for 10-15 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
EFFECT OF PAIN NEUROSCIENC EDUCATION AND PHYSICAL EXERCISE FOR PATIENTS WITH LUMBAR RADICULOPATHY: A RONDAMISED CLINICAL TRAIL

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

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 Mahzaib Khalid gmail: mahzaib01@gmail.com

Where to obtain:
Mahzaib Khalid gmail: mahzaib01@gmail.com

How to obtain:
The data/ document could be used by communicating with the principle investigator Mahzaib Khalid gmail: mahzaib01@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahzaib Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, L Block, Wapda city, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>37000</zip>
        <telephone>+92 305 7666514</telephone>
        <email>mahzaib01@gmail.com</email>
        <affiliation>The university of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahzaib Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Avenue, Faisal Town Canal Road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>37000</zip>
        <telephone>+92 305 7666514</telephone>
        <email>mahzaib01@gmail.com</email>
        <affiliation>The university of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Patients of both genders male and female
•	Age group (40-60)
•	 Lumbar pain which radiates down to leg or radiating below the knee
•	 Diagnosed patients with lumbar radiculopathy
•	As a minimum Pain score 3/10 on VAS
•	The following radicular signs:                                                                                                   1.	Any dermatome between L4 and S1 that is numbness paresthesia                                     2.	Loss of muscle strengthen any of the L4-S1 myotomes</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Spine fracture
•	Pregnancy
•	Cauda equine syndrome
•	Oncological pain
•	History of pelvis, hip or spine surgical intervention in the last year
•	Unimpaired cognition / intelligence (Mini Mental State Examination Score of &gt;24)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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: this group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise (PE) performed session;  3 sessions per week which are consisting on Warm-up, slow and deep breathing exercise for about 3 minutes to relax the patient, then activation and join mobility exercises, balance and agility exercises, strength exercises and resistance training (in includes ankle pump, heel slide, Straight leg raise, Bridging and modified bridging with leg raise, 4 point kneeling, and kneeling with arm and leg lift) hold all positions for 5 to 10 seconds with 10 repetitions starts moderate exercises that was gradually increased. Each exercises session was completed in 35-45 minutes and then cool down phase including with relaxation exercises for 10-15 minutes.</i_keyword>
      <i_keyword>Intervention group: this group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise (PE) performed session;  3 sessions per week which are consisting on Warm-up, slow and deep breathing exercise for about 3 minutes to relax the patient, then activation and join mobility exercises, balance and agility exercises, strength exercises and resistance training (in includes ankle pump, heel slide, Straight leg raise, Bridging and modified bridging with leg raise, 4 point kneeling, and kneeling with arm and leg lift) hold all positions for 5 to 10 seconds with 10 repetitions starts moderate exercises that was gradually increased. Each exercises session was completed in 35-45 minutes and then cool down phase including with relaxation exercises for 10-15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1, 3, 6 week. Method of measurement: Pain intensity: Visual Analogue scale for screening of patients and outcomes measured by Roland Morris low back pain and disability questionnaire,The back pain functional scale , Fear-Avoidance belief questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Disability. Timepoint: 1, 3 ,6 week. Method of measurement: Pain intensity: Visual Analogue scale for screening of patients and outcomes measured by Roland Morris low back pain and disability questionnaire, The back pain functional scale , Fear-Avoidance belief questionnaire.</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>Self Funded</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-09</approval_date>
        <contact_name>Ethical Review Commitee</contact_name>
        <contact_address>University Avenue, Faisal Town Canal Road Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
