<?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>IRCT20230212057390N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of soft tissue release of the thoracic on the improvement of pain, in patients with failed back surgery syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of soft tissue release of the thoracic on the improvement of pain, disability, and quality of life in patients with failed back surgery syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72950</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>failed back surgery syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patient is lying on the stomach and the hands are turned inward and attached to the patient's trunk, then the therapist is placed near the patient and places the palms of the hands in a crosswise manner on the soft tissue on both sides of the back spine and in opposite directions with equal pressure. The patient's tolerance to two opposite sides performs the release of the soft tissue. The duration of treatment is 90 seconds and three times for each treatment session, and the duration of the treatment is 5 minutes (21-23). To perform skin rolling, the patient lies on his stomach and then the therapist performs the massage technique from the bottom up by rolling the soft tissue between the thumb and other fingers. The duration of the technique is between 10 and 20 minutes (24, 25). In addition to receiving intervention, patients benefit from a current physiotherapy with the following characteristics: TENS: frequency 80Hz, deflection 250 microseconds US: pulse for 5 minutes HP: 15 minutes. Intervention 2: Control group: Control group patients benefit from a current physiotherapy with the following characteristics: TENS: frequency 80Hz, deflection 250 microseconds US: pulse for 5 minutes HP: 15 minutes.</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 is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic, scientific and industrial institutions

Conditions:
Those who make a written request and their written request is approved by the university.

Where to obtain:
Refer to the Department of Physiotherapy of Mashhad University of Medical Sciences

How to obtain:
A written request will be given to the physiotherapy department and will be given to the requester if it does not comply with the university rules.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3884 6710</telephone>
        <email>shahbazim2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3884 6710</telephone>
        <email>shahbazim2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>failed back surgery
Not using drugs affecting the functioning of the automatic nervous system</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Patients with a history of spinal fracture
2. Patients with spine abnormalities
3. Patients with fear of light
4. Patients with dysfunctional autonomic nervous system
5. Patients with skin sensitivity
6. Patients with alcohol addiction
7. Patients with Horner's syndrome</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S24.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>آسیب به اعصاب سمپاتیک پشت</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The patient is lying on the stomach and the hands are turned inward and attached to the patient's trunk, then the therapist is placed near the patient and places the palms of the hands in a crosswise manner on the soft tissue on both sides of the back spine and in opposite directions with equal pressure. The patient's tolerance to two opposite sides performs the release of the soft tissue. The duration of treatment is 90 seconds and three times for each treatment session, and the duration of the treatment is 5 minutes (21-23). To perform skin rolling, the patient lies on his stomach and then the therapist performs the massage technique from the bottom up by rolling the soft tissue between the thumb and other fingers. The duration of the technique is between 10 and 20 minutes (24, 25). In addition to receiving intervention, patients benefit from a current physiotherapy with the following characteristics: TENS: frequency 80Hz, deflection 250 microseconds US: pulse for 5 minutes HP: 15 minutes</i_keyword>
      <i_keyword>Control group: Control group patients benefit from a current physiotherapy with the following characteristics: TENS: frequency 80Hz, deflection 250 microseconds US: pulse for 5 minutes HP: 15 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At the start of the trial, five days later, ten days later, and one month afterwards. Method of measurement: Visual analog scale of pain.</prim_outcome>
      <prim_outcome>Disability. Timepoint: At the start of the trial, five days later, ten days later, and one month afterwards. Method of measurement: Oswestry Disability Index.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: At the start of the trial, five days later, ten days later, and one month afterwards. Method of measurement: Functional rating index.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: At the start of the trial, five days later, ten days later, and one month afterwards. Method of measurement: Sphygmomanometer.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-10</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
