<?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>IRCT20220830055833N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-12</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise therapy on pain and disability in patients with low back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of exercise therapy on pain and disability indicators of patients with non-specific back pain in patients referred to the pain clinic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65796</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we prepare cards for the sample size of 50 people, we write the letter A on 25 of the cards and the letter B on the other 25. We put these in a closed envelope. Then we ask the patient to choose one of the cards at the time of visit. If the patient gets card A, he will be in the intervention group, and if he gets card B, he will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group of 25 patients with back pain will be followed up by giving Williams and McKenzie exercises. Exercises are performed during two stages of 6 weeks, in which the first 6 weeks are 6 days a week and the second 6 weeks are 3 days a week, every other day for a total of 12 weeks, and the patients visit the pain clinic monthly. This group also uses uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain. Uniflex tablets contain calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant, and it has been shown that it has cartilage-building and collagen-building effects, which is useful for our study considering the cause of wear and tear, which is cartilage breakdown. Intervention 2: Control group:The control group also uses uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain. Uniflex tablets contain calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant, and it has been shown that it has cartilage-building and collagen-building effects, which is useful for our study considering the cause of wear and tear, which is cartilage breakdown.Community Verified icon.</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:
Only a part of the data, such as the information related to the main outcome or the like, can be shared.

Community Verified icon

When:
Access starts 6 months after the results are published

To whom:
Academic and scientific institutions

Conditions:
The data can be used for additional work and research expansion.

Where to obtain:
Maryam Marzbanfard 09352998417

How to obtain:
The applicant can access the information after contacting Maryam Marzban Fard.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Marzbanfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Alley 1, Shahid Hashemi Nesab St., Shahid Azadian Blvd., Feshar ghavi Square, Phase 2, Golestan, Fasa  Community Verified icon</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461453493</zip>
        <telephone>+98 71 5334 3202</telephone>
        <email>m.marzbanfard95@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Marzbanfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Alley 1, Shahid Hashemi Nesab St., Shahid Azadian Blvd., Feshar ghavi square , Phase 2, Golestan, Fasa  Community Verified icon</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461453493</zip>
        <telephone>+98 71 5334 3202</telephone>
        <email>m.marzbanfard95@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20 to 60 years
Severity of back pain with VAS criteria higher than 3</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having an uncontrollable underlying disease
Presence of back pain without specific symptoms</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group of 25 patients with back pain will be followed up by giving Williams and McKenzie exercises. Exercises are performed during two stages of 6 weeks, in which the first 6 weeks are 6 days a week and the second 6 weeks are 3 days a week, every other day for a total of 12 weeks, and the patients visit the pain clinic monthly. This group also uses uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain. Uniflex tablets contain calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant, and it has been shown that it has cartilage-building and collagen-building effects, which is useful for our study considering the cause of wear and tear, which is cartilage breakdown.</i_keyword>
      <i_keyword>Control group:The control group also uses uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain. Uniflex tablets contain calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant, and it has been shown that it has cartilage-building and collagen-building effects, which is useful for our study considering the cause of wear and tear, which is cartilage breakdown.Community Verified icon</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in Oswestry  Disability Index. Timepoint: Examining the improvement of patient's pain 6 weeks after doing sports exercises. Method of measurement: Oswestry Disability Index Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction score from 0 to 10. Timepoint: Pain score after 6 weeks of exercise. Method of measurement: Patients were asked to rate their satisfaction with exercise from 0 to 10.</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-30</approval_date>
        <contact_name>Ethics committee of  Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Square Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
