<?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>IRCT20160808029264N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-03</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of myofascial release on lumbar kinematics</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Myofascial Release Technique on Lumbar Spine Kinematics in People with Non-Specific Chronic Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57135</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: permuted block randomization:
4 blocks are used for randomization. The intervention groups are called A and the control group is called B. Different 4 blocks including A, B are defined in different permutations. We will have 15 blocks of 4. Each block is assigned a number from 1 to 6. Using a random number generator, the blocks are selected from 6 selected blocks, respectively. Eligible individuals are assigned to either A or B in each block (from left to right) in a predetermined order, Blinding description: Participants will not be aware of their group, nor will the data analyzer be aware of patients being assigned to groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group will receive ten routine sessions of physiotherapy along with four sessions (twice a week for two weeks) of myofascial treatment. Routine physiotherapy includes 20 minutes of using TENS electric current with a frequency of 50 to 120 Hz, 1 MHz Ultrasound with an intensity of 1.5w / cm2 for 5 minutes and a hot pack. Myofascial release protocol will include release of thoracolumbar fascia, paravertebral lumbar muscles, quadratus lumbarum and seasickness. Intervention 2: Control group: Participants in this group will receive ten routine sessions of physiotherapy along with four sessions (twice a week for two weeks) of myofascial treatment. Routine physiotherapy includes 20 minutes of using TENS electric current with a frequency of 50 to 120 Hz, 1 MHz Ultrasound with an intensity of 1.5w / cm2 for 5 minutes and a hot pack. The myofascial release protocol will include the release of the thoracolumbar fascia, the paravertebral lumbar muscles, the quadratus lumbarum, and the seas, which the group will receive as sham.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There are not more informations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasool Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513135111</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>rasool.bagheri@ymail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasool Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513135111</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>rasool.bagheri@ymail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 55 years
People with nonspecific chronic low back pain that lasts for more than 12 weeks
VAS less than 3 per day of study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>BMI above 25
Spinal cord tumor
Infection
Fracture
Autoimmune disease
Vascular disease
Endocrine disease
Metabolic disease
Systemic neoplastic disease
Fibromyalgia
Cauda equina syndrome
Previous spinal surgery
Muscular injuries of the lower extremities
Previous experience with myofascial
History of rehabilitation treatment for low back pain over the past two months</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group will receive ten routine sessions of physiotherapy along with four sessions (twice a week for two weeks) of myofascial treatment. Routine physiotherapy includes 20 minutes of using TENS electric current with a frequency of 50 to 120 Hz, 1 MHz Ultrasound with an intensity of 1.5w / cm2 for 5 minutes and a hot pack. Myofascial release protocol will include release of thoracolumbar fascia, paravertebral lumbar muscles, quadratus lumbarum and seasickness.</i_keyword>
      <i_keyword>Control group: Participants in this group will receive ten routine sessions of physiotherapy along with four sessions (twice a week for two weeks) of myofascial treatment. Routine physiotherapy includes 20 minutes of using TENS electric current with a frequency of 50 to 120 Hz, 1 MHz Ultrasound with an intensity of 1.5w / cm2 for 5 minutes and a hot pack. The myofascial release protocol will include the release of the thoracolumbar fascia, the paravertebral lumbar muscles, the quadratus lumbarum, and the seas, which the group will receive as sham.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kinematic. Timepoint: The first session, last session. Method of measurement: 3D motion analysis system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: The first session, last session. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Disability. Timepoint: The first session, last session. Method of measurement: Oswestry checklist.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-27</approval_date>
        <contact_name>Ethics Comitee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Basij Blvd.,Semnan., Semnan Province Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
