<?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>IRCT20200302046675N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-05</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of physiotherapy , hydrotherapy and combination methods on patients with Lumbar Disc Herniation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of physiotherapy , hydrotherapy and combination methods on pain and Functional Disability in patients with Chronic Low Back Pain due to Lumbar Disc Herniation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46302</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Simple randomization in that a number of cards are considered by the researcher as the first group (physiotherapy) and the same number of cards for other groups (hydrotherapy, combination and control group); Then, by merging the cards together, a card is taken out and its allocation is recorded and returned to the other cards. The cards are then merged again and another card is removed. Also, the number of cards is not necessarily equal to the total number of samples, Blinding description: This is a Single blind clinical trial in which a expert physiotherapist will perform intervention and other physiotherapists will perform the Assessment. As a result, the Assessor will not know which group the patient belongs to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar disc herniation.</hc_freetext>
      <i_freetext>Intervention 1: intervention group 1 : The physiotherapy protocol includes TENS method and exercise therapy. TENS method performed with a multistim device model 735M made by Novin company and exercise therapy is performed in accordance with the evaluation and prescribing instructions of the American School of Sports Medicine. This intervention is performed for 8 weeks and 3 times a week for 60 minutes each time. Intervention 2: intervention group 2 : Hydrotherapy, These exercises were performed in water with a depth of 1 to 2 meters and a temperature of 28 to 32 degrees Celsius. Exercises three times a week for 8 weeks, each time for 60 minutes. Intervention 3: Intervention group 3 : combination group , Treatment in this group was a combination of physiotherapy and hydrotherapy. Thus, in the first month, three sessions per week and 60 minutes per session, physiotherapy and in the second month, three sessions per week and each session 60 minutes, hydrotherapy is performed. Intervention 4: Control group : Patients are told not to use any treatment model for eight weeks and to rest completely.</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:
If needed by researchers and their request, the raw data of research and it's analysis will be available to researchers

When:
After the publication of articles resulting from the research

To whom:
Researchers working in academic institutions

Conditions:
The data are available only to other researchers to study and evaluate treatment outcomes.

Where to obtain:
By sending an email to the corresponding author

How to obtain:
Send an email and the request will be answered shortly after review.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Shams Tabar Kami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 62, Ghaem St., Khoshroudpy, Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4733155987</zip>
        <telephone>+98 11 3252 9427</telephone>
        <email>m_shamskamangir14@yahoo.com</email>
        <affiliation>The University of Shams</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Shams Tabar Kami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 62, Ghaem St., Khoshroudpi, Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4733155987</zip>
        <telephone>+98 11 3252 3403</telephone>
        <email>m_shamskamangir14@yahoo.com</email>
        <affiliation>The University of shams</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body Mass Index between 20-25
Having moderate pain means a minimum of 4 and a maximum of 7 with a Visual Analouge Scale index
Men with chronic low back pain caused by a lumbar disc herniation with a history of pain of more than three months</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of lumbar surgery
Use of special medications and painkillers
History of underlying diseases such as heart disease, respiratory disease, diabetes, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group 1 : The physiotherapy protocol includes TENS method and exercise therapy. TENS method performed with a multistim device model 735M made by Novin company and exercise therapy is performed in accordance with the evaluation and prescribing instructions of the American School of Sports Medicine. This intervention is performed for 8 weeks and 3 times a week for 60 minutes each time.</i_keyword>
      <i_keyword>intervention group 2 : Hydrotherapy, These exercises were performed in water with a depth of 1 to 2 meters and a temperature of 28 to 32 degrees Celsius. Exercises three times a week for 8 weeks, each time for 60 minutes.</i_keyword>
      <i_keyword>Intervention group 3 : combination group , Treatment in this group was a combination of physiotherapy and hydrotherapy. Thus, in the first month, three sessions per week and 60 minutes per session, physiotherapy and in the second month, three sessions per week and each session 60 minutes, hydrotherapy is performed.</i_keyword>
      <i_keyword>Control group : Patients are told not to use any treatment model for eight weeks and to rest completely.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, the eighth week of treatment. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before treatment, the eighth week of treatment. Method of measurement: Oswestry Disability Questionnaire (ODQ).</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-15</approval_date>
        <contact_name>Ethics committee of babol University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences,Ganj Afrooz St,Babol,Mazandaran Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
