<?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>IRCT20200425047197N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of FASD,Acupuncture and physiotherapy on low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Basilic vein FASD(Blood letting) with Acupuncture and Physiotherapy on pain and disability of patients with chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47512</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, Basilic vein venisection(FASD) will be prescribed and will be performed in two stages.The Scalpe(bistoury) used is number 11, the gap created is two to five millimeters and the amount of blood taken is about fifty to one hundred cc ans the venisection site will then be dressed. The basilic vein runs down the inside of the forearm. To perform the procedure, you must first find out where the artery is in the vein. If it is below the vein, which is often the case, the blade should be inserted so that only the upper surface of the vessel is opened longitudinally so that it does not reach the lower surface of the artery. The second phase of Fasd will be performed 2 weeks after the start of treatment. Intervention 2: Intervention group: Patients in the acupuncture group visit 10 sessions of acupuncture during regular planning. Acupuncture is performed three times a week for each person. Each treatment session lasts about 20 minutes when the localized points are connected to the electrode device and acupuncture is performed with electrical stimulation (electroacupuncture). The choice of localized points is made by the therapist (acupuncturist) according to the patient's condition and after the examination. In addition to the local points, the other points selected based on the references will be: DU4, UB23, UB40, Ki3, DU20The needles used will be 0.25 x 40. Intervention 3: Control group: Patients in the physiotherapy group undergo regular sessions of 10 sessions to perform standard physiotherapy for chronic low back pain.</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:
All data can be shared after people have not been identified

When:
Start the access period 6 months after the publication of the results

To whom:
Data will only be available to researchers working at academic and scientific institutions

Conditions:
Any scientific use of the data with mentioning the reference is unrestricted

Where to obtain:
Applicants can contact us via email below to receive data and any information
Jamali.msb@gmail.com

How to obtain:
After submitting the applicant's application and coordinating with the supervisor, the information plan will be provided to the applicant as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moein Jamali Dastjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Sarparast St, West Taleghani Ave, Felestin Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416663361</zip>
        <telephone>+98 21 8897 4535</telephone>
        <email>jamali-m@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrdad Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Sarparast St, West Taleghani Ave, Felestin Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416663361</zip>
        <telephone>+98 21 4535 8897</telephone>
        <email>Mehrdadkarimi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Personal and conscious consent of the individual to participate in the research project
Chronic mechanical low back pain without any specific pathology such as inflammation of the nerve root, spinal stenosis, spondylolysis, spondylolisthesis, vertebral fracture
A history of more than three months of pain
Confirmation of chronic low back pain and clinical examination by a specialist to rule out any pathology
Age range between 30 and 70 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or lactation
Surgical history due to low back pain
Non-mechanical back pain (wakes the patient up at night or causes pain and dryness in the morning)
History of trauma, especially in the elderly
Fever, sweating and weight loss without justification in recent months
Long-term treatment with corticosteroeids
Symptoms of cauda aquina syndrome include numbness and weakness in both legs, anal pain, perineal numbness or paresthesia, sphincter paralysis.
Ankylosing spondylitis and inflammatory rheumatoid arthritis
Existence of neuropathy or neurological problems during the examination
Severe untreated scoliosis
Infection at the site or spinal cord
Acute radiculopathy (active herniated disc)
Psychopathic disorders
Uncontrolled diabetes or high blood pressure
Participatory low back pain such as uterine or gastrointestinal involvement such as IBD
Consumption of digoxin, warfarin, heparin
Drug addiction, sedatives, alcohol, etc.
Injecting anesthetics or corticosteroids for up to 4 weeks before starting treatment
Fainting history after FASD or Hijamat(wet cupping)</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 - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, Basilic vein venisection(FASD) will be prescribed and will be performed in two stages.The Scalpe(bistoury) used is number 11, the gap created is two to five millimeters and the amount of blood taken is about fifty to one hundred cc ans the venisection site will then be dressed. The basilic vein runs down the inside of the forearm. To perform the procedure, you must first find out where the artery is in the vein. If it is below the vein, which is often the case, the blade should be inserted so that only the upper surface of the vessel is opened longitudinally so that it does not reach the lower surface of the artery. The second phase of Fasd will be performed 2 weeks after the start of treatment.</i_keyword>
      <i_keyword>Intervention group: Patients in the acupuncture group visit 10 sessions of acupuncture during regular planning. Acupuncture is performed three times a week for each person. Each treatment session lasts about 20 minutes when the localized points are connected to the electrode device and acupuncture is performed with electrical stimulation (electroacupuncture). The choice of localized points is made by the therapist (acupuncturist) according to the patient's condition and after the examination. In addition to the local points, the other points selected based on the references will be: DU4, UB23, UB40, Ki3, DU20The needles used will be 0.25 x 40.</i_keyword>
      <i_keyword>Control group: Patients in the physiotherapy group undergo regular sessions of 10 sessions to perform standard physiotherapy for chronic low back pain.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity and disability score in Oswestry questionnaire. Timepoint: Before Intervention and After end of Intervention and 1 month after end of intervention. Method of measurement: Oswestry questionnaire.</prim_outcome>
      <prim_outcome>Pain intensity score in VAS (Visual Analogue Scale) questionnaire. Timepoint: Before Intervention and After the first intervention session and After end of Intervention and 1 month after end of intervention. Method of measurement: VAS (Visual Analogue Scale) questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-11</approval_date>
        <contact_name>Iran National Committee for Ethics in Biomedical Research</contact_name>
        <contact_address>No. 27, Sarparast St, West Taleghani Ave, Felestin Sq Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
