<?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>IRCT20210822052250N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-24</date_registration>
      <primary_sponsor>Green international University</primary_sponsor>
      <public_title>Effects of magnetotherapy and lumbar traction on the patients of sciatica</public_title>
      <acronym></acronym>
      <scientific_title>Effects of magnetotherapy and lumbar traction on the patients of sciatica</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 patients have been selected by simple random sampling. participants names are drawn randomly from a pool where everyone has an even probability of being chosen. The participants are then asked to pick up the sealed opaque envelope on the basis of which participants are divided into 2 equal groups. The participants who choose sealed envelope with Group A are placed in Group A and those choose Group B are placed in group B. both groups contain 30 participants each, Blinding description: Assessment and treatment will be performed by two individuals. Assessor and analyzer of the data are those who are unaware of the grouping and will be unaware of which group each subject belongs to. The assessor is present only at the time of assessment (before and after treatment).</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sciatica.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In this group, patients with sciatica are exposed to regular soft tissue release, isometric exercises, stretching and Lumbar traction. these individuals are not exposed to magnetotherapy unit. Intervention 2: Intervention group 2:  In this group, patients with sciatica are exposed to regular soft tissue release, isometric exercises, stretching, Lumbar traction and magnetotherapy. these individuals are exposed to magnetotherapy unit which is a special modality based on biomagnetism. the upper pole is north while the lower pole is south. the field generate in north to south direction, pressing the disc bulge to the neutral position.</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:
Effects of magnetotherapy and traction on the patients of sciatica

When:
data will be available after publication for 2 months

To whom:
to the research committees only

Conditions:
copy right

Where to obtain:
from the primary author only

How to obtain:
simple email the primary author by mentioning the reason

Comments:
no other information will be required</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohtishim Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Johar medicare complex, 36-R, Shahalam Road, near Ayub chowk, Johar town, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 313 4414456</telephone>
        <email>mohtishimahmed77@gmail.com</email>
        <affiliation>Green international university, lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohtishim Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>green international university, 9km raiwind road, bhoptian chowk, lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 313 4414456</telephone>
        <email>mohtishimahmed77@gmail.com</email>
        <affiliation>Green international university, lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having mechanical neck pain more than three months and less than two years
age between 25 and 60 years
having normal laboratory test results
absence of fracture, dislocation, tumor or infection on radiological investigation
pain severity of at least 4/10 according to the visual analog scale (VAS)
willingness to sign the informed consent form.
Presence of disc bulge, protrusion or herniation at L4-L5, and L5-S1 level</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy and breastfeeding
having a cardiac pacemaker implanted
metal implant or electronic device in any part of body
a prior trauma (whiplash), surgical or algological intervention in lumbar area
history or suspicion of any malignancy
presence of inflammatory joint pain or diagnosis of a rheumatic disease
presence of an open superficial wound
presence of more severe pain in any part of body other than low back pain
an advanced stage mood disorder, a neurological disorder (multiple sclerosis, syringomyelia, or Parkinson’s disease)
radiographical Grade ≥2 spondylolisthesis, spinal instability or advanced spondylarthrosis
physical therapy for back pain within the last six months
a history of drug use other than paracetamol (NSAIDs, centrally acting and narcotic analgesics) or discontinuation of such drugs less than three months before the enrolment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sciatica</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In this group, patients with sciatica are exposed to regular soft tissue release, isometric exercises, stretching and Lumbar traction. these individuals are not exposed to magnetotherapy unit.</i_keyword>
      <i_keyword>Intervention group 2:  In this group, patients with sciatica are exposed to regular soft tissue release, isometric exercises, stretching, Lumbar traction and magnetotherapy. these individuals are exposed to magnetotherapy unit which is a special modality based on biomagnetism. the upper pole is north while the lower pole is south. the field generate in north to south direction, pressing the disc bulge to the neutral position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Daily overall pain level. Timepoint: 3 days. Method of measurement: scale of 0 to 10.</prim_outcome>
      <prim_outcome>Pain in the low back. Timepoint: 3 days. Method of measurement: 0-10 pain scale.</prim_outcome>
      <prim_outcome>Pain in the lower extremities. Timepoint: 3 days. Method of measurement: 0-10 pain scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: 3 days. Method of measurement: questionnaire: SF 36.</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>Green international University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-15</approval_date>
        <contact_name>Research and ethics committee GIU</contact_name>
        <contact_address>Green international university, 9km raiwind road, bhoptian chowk Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
