<?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>IRCT20201207049636N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-23</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of trigger point acupuncture and traditional acupuncture on low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of trigger point acupuncture and traditional acupuncture on low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53029</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 48 identical envelopes are prepared for randomization, The name of the intervention (types of intervention) is evenly placed in each envelope (16 envelopes per intervention). After closing the envelopes, the envelopes are shuffled so that the sequence of interventions is not clear. Each participant randomly selects one of the envelopes And after opening the envelope, the examiner will perform the type of treatment based on the treatment in the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>low back pain.</hc_freetext>
      <i_freetext>Intervention 1: 1st Intervention group: In the trigger point acupuncture group, the treatment will be performed for up to 6 sessions, Once every two days, for 12 days with disposable dong-bang needles of stainless steel in the size of 0.25 × 0.4. After sterilizing with alcohol, the needle enters into the painful points, which are called trigger points. The needles are inserted by the guide tube in the marked painful points and the insertion depth of the needles is 15 to 30 mm. Which remain in place for 20 minutes per session, while at the 10th minute the needles are rotated for re-stimulation. Intervention 2: 2nd Intervention group: In the traditional acupuncture group, treatment is done for up to 6 sessions, Once every two days, for 12 days and points have been determined based on the principles of Chinese medicine and meridian lines that these points in low back pain will include BL20-BL23-ST40-BL63-SP3-SP10-LIV6-P6-P7. In these patients, disposable Dong-Bang stainless steel needles in the size of 0.25 × 0.4 are inserted after sterilizing the points with alcohol cotton by the guide tube. The insertion depth of the needles is 15-30 mm and remains for twenty minutes. The needles in the traditional acupuncture group must be rotated and manipulated in place to achieve a feeling of numbness and heaviness or temporary burning at the site, which is called de qi sensation. Intervention 3: Control group: In the control group, patients will have only standard low back pain exercise and NSAID use.</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:
Table of data obtained from the mentioned questionnaires

When:
Access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
The use of documents is allowed only by mentioning the source.

Where to obtain:
Dr. Kourosh Mansouri, Department of Physical Medicine and Rehabilitation,  Shafaiehian Hospital, Baharestan Square, Tehran, 09156538667, taghizadehf892@gmail.com.

How to obtain:
The data is provided to the individual as soon as it is authenticated.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Korosh Mansori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8214 1600</telephone>
        <email>mansori.k@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Korosh Mansori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۵۹۳۷۴۷۸۱۱</zip>
        <telephone>+98 21 8214 1600</telephone>
        <email>mansori.k@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Of the patients who presented with complaints of low back pain, 48 patients were studied.
Patients should be in the age range of 18 to 60 years.
All patients should have at least one active trigger point.
Patients must have a vas (visual analog scale) score more than 4.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Neuromuscular junction disorders
Neurological defects found in electromyography
Progressive neurological defects
Urinary or fecal incontinence following pain
Progressive decrease in muscle strength
Lumbar orthopedic disorders or a history of lumbar surgery
Rheumatologic disorders
Diagnosed history of hip and sacroiliac joint problems
Known psychological disorders
Cancer</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1st Intervention group: In the trigger point acupuncture group, the treatment will be performed for up to 6 sessions, Once every two days, for 12 days with disposable dong-bang needles of stainless steel in the size of 0.25 × 0.4. After sterilizing with alcohol, the needle enters into the painful points, which are called trigger points. The needles are inserted by the guide tube in the marked painful points and the insertion depth of the needles is 15 to 30 mm. Which remain in place for 20 minutes per session, while at the 10th minute the needles are rotated for re-stimulation.</i_keyword>
      <i_keyword>2nd Intervention group: In the traditional acupuncture group, treatment is done for up to 6 sessions, Once every two days, for 12 days and points have been determined based on the principles of Chinese medicine and meridian lines that these points in low back pain will include BL20-BL23-ST40-BL63-SP3-SP10-LIV6-P6-P7. In these patients, disposable Dong-Bang stainless steel needles in the size of 0.25 × 0.4 are inserted after sterilizing the points with alcohol cotton by the guide tube. The insertion depth of the needles is 15-30 mm and remains for twenty minutes. The needles in the traditional acupuncture group must be rotated and manipulated in place to achieve a feeling of numbness and heaviness or temporary burning at the site, which is called de qi sensation.</i_keyword>
      <i_keyword>Control group: In the control group, patients will have only standard low back pain exercise and NSAID use.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain reported by the patient in the vas questionnaire. Timepoint: The beginning of the intervention, one week, one month and three months later. Method of measurement: Vas pain measurement questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient's disability based on Oswestry Disability Index (ODI) questionnaire. Timepoint: The beginning of the intervention, one week, one month and three months later. Method of measurement: ODI Disability Questionnaire.</sec_outcome>
      <sec_outcome>Kinesiophobia. Timepoint: The beginning of the intervention, one week, one month and three months later. Method of measurement: kinesiophobia TSK (Tampa Scale of Kinesiophobiais) Questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-04</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
