<?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>IRCT20200422047172N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-21</date_registration>
      <primary_sponsor>Department of Physical Education, Sport and Physiotherapy, University of Oradea</primary_sponsor>
      <public_title>Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion.</public_title>
      <acronym>CRP</acronym>
      <scientific_title>Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion. Is Early Intervention the Best Recommendation?</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62461</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: All assessments were made before intervention and 6 months later by the same physiotherapist, who was blinded to the treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1/Experimental group: 30 patients received a complex individualized physical therapy (PT) program associated with hydro-therapy(HT) and electrotherapy (ET).  Hydrotherapy was performed in a therapeutic pool for 30 min a day, 5-days a week for a total duration of 10 days. The PT program was given to all patients for 45 min a day, 5-days a week for a total duration of 10 days. After completing the exercise PT program, electrotherapy ET was applied to each patient. The electrotherapy ET procedures consisted of: 1) Transcutaneous electrical nerve stimulation (TENS) in conventional mode, symmetric biphasic, 90 Hz, for 15 min; 2) Interferential current (IFC) in quadripolar mode, at 100 Hz frequency, for 10 min; 3) Magnetic field therapy in continuous form (sedative effect), for 15 min.  TENS and IFC were performed using the Chattanooga Intelect Neo combined de-vice. The magnetic field was delivered through a Physiomed MAG-Expert device with a field strength of 1–100 Gauss (adjustable in steps of one Gauss) and a frequency range from 1 to 100 Hz, with two completely independent channels and a treatment timer. Intervention 2: Intervention group/Control group: 30 patients received classical electrotherapy program (ET) for 10 days. The electrotherapy ET protocol was the same as for the experimental group (TENS, IFC, Magnetic field therapy).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elena Sirbu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Parvan Street</address>
        <city>Timisoara</city>
        <country1>Romania</country1>
        <zip>300233</zip>
        <telephone>+40 744 238 960</telephone>
        <email>elena.sirbu@e-uvt.ro</email>
        <affiliation>West University of Timisoara</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elena Sirbu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, V Parvan</address>
        <city>Timisoara</city>
        <country1>Romania</country1>
        <zip>300233</zip>
        <telephone>+40 744 238 960</telephone>
        <email>elena.sirbu@e-uvt.ro</email>
        <affiliation>West University of Timisoara</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Romania</country2>
    </countries>
    <criteria>
      <inclusion_criteria>25-80 years of age
low back pain for more than three months
MRI confirmed diagnosis of lumbar disc protrusion (without dural compression)
ability to perform a physical therapy program</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>76 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>indication for acute surgery
previous surgery on the same lumbar spinal level
sciatica
presence of severe spinal pathology (spinal tumour, spinal fracture, spinal stenosis or radiculopathy, fibromyalgia, inflammatory and infectious spinal diseases)
chronic use of pain killer drugs
refusal to participate in the research
neoplasms of any sort, severe comorbidities
mental illness
refusal to participate in the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.86</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intervertebral disc disorders, 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/Experimental group: 30 patients received a complex individualized physical therapy (PT) program associated with hydro-therapy(HT) and electrotherapy (ET).  Hydrotherapy was performed in a therapeutic pool for 30 min a day, 5-days a week for a total duration of 10 days. The PT program was given to all patients for 45 min a day, 5-days a week for a total duration of 10 days. After completing the exercise PT program, electrotherapy ET was applied to each patient. The electrotherapy ET procedures consisted of: 1) Transcutaneous electrical nerve stimulation (TENS) in conventional mode, symmetric biphasic, 90 Hz, for 15 min; 2) Interferential current (IFC) in quadripolar mode, at 100 Hz frequency, for 10 min; 3) Magnetic field therapy in continuous form (sedative effect), for 15 min.  TENS and IFC were performed using the Chattanooga Intelect Neo combined de-vice. The magnetic field was delivered through a Physiomed MAG-Expert device with a field strength of 1–100 Gauss (adjustable in steps of one Gauss) and a frequency range from 1 to 100 Hz, with two completely independent channels and a treatment timer.</i_keyword>
      <i_keyword>Intervention group/Control group: 30 patients received classical electrotherapy program (ET) for 10 days. The electrotherapy ET protocol was the same as for the experimental group (TENS, IFC, Magnetic field therapy)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention and 6 months after intervention. Method of measurement: Short Form McGill Pain Questionnaire (SF-MPQ) and visual analogue scale (VAS).</prim_outcome>
      <prim_outcome>Disability. Timepoint: before intervention and 6 months after intervention. Method of measurement: Oswestry Disability Index (ODI).</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>Department of Physical Education, Sport and Physiotherapy, University of Oradea</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-14</approval_date>
        <contact_name>Local Ethics Committee, University of Oradea</contact_name>
        <contact_address>Str. Universităţii nr. 1 Oradea Bihor Romania</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
