<?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>IRCT2012061810060N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-09</date_registration>
      <primary_sponsor>Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Science</primary_sponsor>
      <public_title>The effectiveness of of Iraninan traditional massage on low-back-pain</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of one type of Iranian Traditonal massage on lumbar radiculopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10539</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Traditional massage explanation&#13;
The Maneuvers done in therapy sessions consist of:&#13;
•	Lower limb massages (Anterior, posterior, internal &amp; external borders); this massage is done 1 time by massager's palm in each therapy session and 5 times every day by someone else (family) at home. &#13;
- Anterior massage; in supine position massage starts from inguinal region to ankle without significant pressure on the knee&#13;
-Internal lateral massage; in supine position massage starts on internal lateral of lower limb, starts from inguinal to ankle.&#13;
-External lateral massage; in supine position massage starts on external lateral of lower limb, starts from hip to ankle.&#13;
- Posterior; in prone position lower limbs given massage from hip to ankle.&#13;
&#13;
•	Plantar Massage: Feet palms are massaged by a cylinder shape instrument or wood rolling pin.&#13;
&#13;
•	Lumbar massage (7 parts) &#13;
1- Lumbar region is massaged several minutes using almond oil for relaxing muscles and fascias.&#13;
2- Cross massage; patient lays in supine position crosses one lower limb over the other, fixing his or her body grasping bed sides. The massager massages the above limb which is stretched from proximal to distal regarding same general conditions. &#13;
3- knee-chest (prostrate) or fetus position massage; patient is given massage in knee-chest (prostrate) position. If this position is difficult he/she may lie on the side folding lower limbs like fetus position, instead.&#13;
4- Stretching upward (in case of severe lumbar stiffness); Patient lies in supine position, someone raises lower limbs one to one to separate lumbar region from bed then the massager massages  stretched back.&#13;
5- Massage paraverterbral muscles; patient's paravertebral muscles are given massage in prone position by massager's thumb (circulating pressure by thumb) from neck to end of spine several times.  &#13;
6- Skin pinch; different parts of back skin and subcutaneous tissue are pressed between 1th and 2nd fingers of both massager's hand  and pulled out in prone position to recover skin and fascia elasticity. Cupping is a replacement for this maneuver. &#13;
7- Kneading back muscles &amp; stretch; Patient lies in prone extending his/her upper limbs fixing body by grasping bed top, someone pulls the lower limbs. The massager massages his/her back and lower limbs in stretched position.&#13;
•	Trigger points release; tender points found in massage process are being pressed to release.&#13;
•	Cupping; cupping with several size cups is done to improve blood circulation if signs and symptoms of poor circulation are present.&#13;
•	Dressing; after massage session and rubbing oil, patient's back is dressed and wrapped by cotton cloth (30 cm * 400 cm). &#13;
•	Abdomen massage; since constipation delays low back pain recovery, abdomen is massaged by massager's palm clockwise to help stool movement.&#13;
*All massages done by massager's hand, apply pressure about 1 kg force. Intervention 2: Control group: standard medical treatment for lumbar radiculopathy by neurosurgeon.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mamak Hashemi Habibabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behesht St, Vahdat Islami St, Hafez Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5560 1274</telephone>
        <email>m-hashemi@tums.ac.ir; mamak.hashemi@yahoo.com</email>
        <affiliation>Traditional Medicine Faculty, Tehran University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mamak Hashemi Habibabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behesht St, Vahdat Islami St, Hafez Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5560 1274</telephone>
        <email>m-hashemi@razi.tums.ac.irmamak78@gmail.com</email>
        <affiliation>Traditional medicine faculty, Tehran university of medical sciences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: lumbar radiculopathy radiating below the knee; pain lasting longer than 8 weeks (continuous or non- continuous); age between 25-55 years old; no indication for surgery or patient's disagreement or medical problem interfering surgery in case of surgery indication. &#13;
Exclusion criteria: history of low-back surgery; any suspicious sign during the treatment period requiring further evaluating or intervention; red flag signs; sign &amp; symptoms of "Quadra Equina" syndrome (Numbness or weakness of the muscles of the lower extremeties,Anus pain, perineal or saddle anesthesia, bowel and bladder disturbances, absent lower spincture  reflexes, sexual dysfunction); accelerating picture of pain in acute phase; sever or exacerbated pain picture; patient's disagreement.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.1+</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lumbar and other intervertebral disc disorders with radiculopathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Traditional massage explanation&#13;
The Maneuvers done in therapy sessions consist of:&#13;
•	Lower limb massages (Anterior, posterior, internal &amp; external borders); this massage is done 1 time by massager's palm in each therapy session and 5 times every day by someone else (family) at home. &#13;
- Anterior massage; in supine position massage starts from inguinal region to ankle without significant pressure on the knee&#13;
-Internal lateral massage; in supine position massage starts on internal lateral of lower limb, starts from inguinal to ankle.&#13;
-External lateral massage; in supine position massage starts on external lateral of lower limb, starts from hip to ankle.&#13;
- Posterior; in prone position lower limbs given massage from hip to ankle.&#13;
&#13;
•	Plantar Massage: Feet palms are massaged by a cylinder shape instrument or wood rolling pin.&#13;
&#13;
•	Lumbar massage (7 parts) &#13;
1- Lumbar region is massaged several minutes using almond oil for relaxing muscles and fascias.&#13;
2- Cross massage; patient lays in supine position crosses one lower limb over the other, fixing his or her body grasping bed sides. The massager massages the above limb which is stretched from proximal to distal regarding same general conditions. &#13;
3- knee-chest (prostrate) or fetus position massage; patient is given massage in knee-chest (prostrate) position. If this position is difficult he/she may lie on the side folding lower limbs like fetus position, instead.&#13;
4- Stretching upward (in case of severe lumbar stiffness); Patient lies in supine position, someone raises lower limbs one to one to separate lumbar region from bed then the massager massages  stretched back.&#13;
5- Massage paraverterbral muscles; patient's paravertebral muscles are given massage in prone position by massager's thumb (circulating pressure by thumb) from neck to end of spine several times.  &#13;
6- Skin pinch; different parts of back skin and subcutaneous tissue are pressed between 1th and 2nd fingers of both massager's hand  and pulled out in prone position to recover skin and fascia elasticity. Cupping is a replacement for this maneuver. &#13;
7- Kneading back muscles &amp; stretch; Patient lies in prone extending his/her upper limbs fixing body by grasping bed top, someone pulls the lower limbs. The massager massages his/her back and lower limbs in stretched position.&#13;
•	Trigger points release; tender points found in massage process are being pressed to release.&#13;
•	Cupping; cupping with several size cups is done to improve blood circulation if signs and symptoms of poor circulation are present.&#13;
•	Dressing; after massage session and rubbing oil, patient's back is dressed and wrapped by cotton cloth (30 cm * 400 cm). &#13;
•	Abdomen massage; since constipation delays low back pain recovery, abdomen is massaged by massager's palm clockwise to help stool movement.&#13;
*All massages done by massager's hand, apply pressure about 1 kg force.</i_keyword>
      <i_keyword>Control group: standard medical treatment for lumbar radiculopathy by neurosurgeon.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, 1 &amp; 3 months after intervention initiation. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Low back Pain disability. Timepoint: Before intervention, 1 &amp; 3 months after intervention initiation. Method of measurement: Standard Rolland-Morris Questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention, 1 &amp; 3 months after intervention initiation. Method of measurement: W.H.O Quality of life Questionnaire (BREF).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Tehran University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Science</source_name>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Medical Ethics Comittee in research, Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Keshavarz Blvd, Qods St, Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
