<?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>IRCT20210221050441N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-30</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of conventional physiotherapy and conventional physiotherapy with lumbar multifidus dry needling on pain, disability and pressure pain threshold in patients with chronic non specific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of conventional physiotherapy and conventional physiotherapy with lumbar multifidus dry needling on pain, disability and pressure pain threshold in patients with chronic non specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64414</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: It is done by randomization secretary and permuted-block method with blocks of volume 4 . In this method, there are ten blocks of 4 in the form of a list, each block has 4 numbers that are randomly designed by the statistical analyzer. In each block, 2 smaller numbers are allocated to the conventional physiotherapy group and 2 larger numbers are assigned to the conventional physiotherapy group  with dry needling. When referring to these groups, the samples are randomly placed from the first to the last list and two people in the intervention group and two people in the control group in each block, Blinding description: To blind the statistician, he analyzes the results without knowing the groups.
To blinding patients,  patient  placed in the prone position and shows the patient the real needle, but when the needle is inserted, a false needle (through the tooth) is struck on the skin and after that the patient does not see the false needle.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic non specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 20 people are included in this group and 8 conventional physiotherapy sessions include: 20 minutes  TENS, 4 minutes  US and 15 minutes  Hot pack, in addition  conventional exercises including  knee to chest , raising the trunk in prone position,heel slide in supine position , bridging and bicycle training. Each exercise will be repeated 10 times and each repetition will be done for 10 seconds. Intervention 2: Intervention group: 20 people are included in this group and 8 conventional physiotherapy sessions in addition dry needling of the multifidus muscle includes: 20 minutes of TENS, 4 minutes of US and 15 minutes of Hot pack, in addition  conventional exercises including knee to chest , raising the trunk in prone position,heel slide in supine position , bridging and bicycle training, as well as three sessions of dry needling in the second, fourth, sixth session and inserting and removing the needle into the muscle for 10 seconds. Each exercise will be repeated 10 times and each repetition will be done for 10 seconds.</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:
The personal information of the persons and the results of the treatment and their relationship cannot be shared with each other, only the analyzed information without mentioning the names of the persons is accessible to other researchers.

When:
Since the publication of the results

To whom:
Researchers and other physiotherapists

Conditions:
In order to access for the design of other studies by researchers and to increase the quality of treatment by colleagues and other physiotherapists

Where to obtain:
Author

How to obtain:
If the request is registered in the email, it will be answered as soon as possible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Heshmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences , Isfahan University of Medical Sciences , Hazar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5024</telephone>
        <email>heshmatipour@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Heshmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences , Isfahan University of Medical Sciences , Hazar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5024</telephone>
        <email>heshmatipour@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Back pain between the 12th rib and the buttock area
Age between 18 and 50 years
active trigger point in the lumbar multifidus muscle
At least three months of low back pain
BMI&lt;40 kg/m2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Rheumatic and systemic diseases
Contraindications of dry needling such as: trauma, taking anticoagulants, infections, immune and heart diseases
fibromyalgia syndrome and neurological problems
Pregnancy, mental disorders, previous lumbar surgery
Uncontrolled endocrine disorders</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>Control group: 20 people are included in this group and 8 conventional physiotherapy sessions include: 20 minutes  TENS, 4 minutes  US and 15 minutes  Hot pack, in addition  conventional exercises including  knee to chest , raising the trunk in prone position,heel slide in supine position , bridging and bicycle training. Each exercise will be repeated 10 times and each repetition will be done for 10 seconds.</i_keyword>
      <i_keyword>Intervention group: 20 people are included in this group and 8 conventional physiotherapy sessions in addition dry needling of the multifidus muscle includes: 20 minutes of TENS, 4 minutes of US and 15 minutes of Hot pack, in addition  conventional exercises including knee to chest , raising the trunk in prone position,heel slide in supine position , bridging and bicycle training, as well as three sessions of dry needling in the second, fourth, sixth session and inserting and removing the needle into the muscle for 10 seconds. Each exercise will be repeated 10 times and each repetition will be done for 10 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before, after and one month after treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pressure pain Threshold. Timepoint: Before, after and one month after treatment. Method of measurement: Algometer.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before, after and one month after treatment. Method of measurement: oswestry disability index.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-06</approval_date>
        <contact_name>Ethics committee of Isfahan university of medical science</contact_name>
        <contact_address>Isfahan University of Medical Sciences , Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
