<?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>IRCT20210516051322N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-24</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of nerve mobilization and vertebral mobilization in patients with back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of nerve tissue mobilization and Mulligan mobilization techniques in patients with lumbar radiculopathy; a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74819</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In the discussion of Mulligan vertebral mobilization, we will use the mobilization with leg movement technique, so far there is no article that has worked on this Mulligan technique in lumbar radiculopathy, so the principle of innovation is in the implementation method. The next point is that no study has been done comparing these two manual treatments in lumbar radiculopathy with the control group that performs routine physiotherapy. Meanwhile, the results of the studies that have compared these two methods have sometimes been contradictory. It should be noted that most of the participants in this study are military personnel and it has been proven that one of the common musculoskeletal problems in military personnel is back pain Aggression is done along with the control group, Randomization description: Simple randomization is done using sealed envelopes
A sealed envelope is assigned to each participant in the plan for random entry into one of the groups. After opening it, we will find out which group the participant belongs to. Of course, they don't see these envelopes and only the researcher notices.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar Radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Control group: routine physiotherapy (electrotherapy including the use of ultrasound devices, tennis currents, infrared rays, and therapeutic exercise including isometric contraction of paravertebral muscles, diaphragmatic, mobility, McKenzie and Williams method) and massage which is performed during 10 sessions, including 3 sessions of 1 hour each week. Intervention 2: Intervention group: Mulligan vertebral mobilization with routine physical  therapy That is, only Mulligan vertebral mobilization is added to the treatment content of the control group that was mentioned with the same conditions of duration of sessions and treatment program. Mulligan Vertebral Mobilization is a method under manual therapy that manipulates the vertebrae of the spine with or without movement of the lower limbs, where the method of manipulating the vertebrae in the appropriate direction of flexion or extension using the movement of the lower limbs is about 15 minutes. It will be added to the routine treatment in each session. Intervention 3: Intervention group: Nerve mobilization along with routine physiotherapy That is, to the treatment content of the control group that was mentioned, with the same conditions of the duration of the sessions and treatment program, only nerve mobilization is added.Nerve mobilization is a method of manual therapy that uses the movement of the joints, the body is placed in positions that cause shortening and lengthening of the nerves branched from nerve networks such as femoral and sciatic, etc., which have anti-inflammatory effects and It has pain relief and in this group, 15 minutes will be added to the routine treatment for each session.</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 information related to the three questionnaires, the individual data of the participants in the study are coded and do not include names. All information from these questionnaires can be published after the end of the patient recruitment process and the end of the trial sessions. Questionnaires include VAS-Oswestry Disability Index-Quebec Low Back Pain Disability Scale

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

To whom:
Researchers of relevant topics such as medical science groups

Conditions:
Medical science researchers who are working under the name of research institutes and educational centers.
There will be no obstacle for using the documents by mentioning the source of the documents and the name of the researchers of this trial.

Where to obtain:
1. Dr. Vahid Sobhani, faculty member of Baqiyatullah University via email
sobhani518@gmail.com
2. Amir Dodangeh, Master of Physiotherapy, via email
amirdodangeh76@gmail.com

How to obtain:
After emailing the mentioned people and providing scientific research information, these statements will be verified and the requester will receive the confirmation, then the documents will be emailed to them within 10 days after the confirmation of the documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Dodangeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Sheikh Bahai Street, Vanak Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915392</zip>
        <telephone>+98 21 8804 0060</telephone>
        <email>Amirdodangeh76@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Vahid Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Sheikh Bahai Street, Vanak Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915392</zip>
        <telephone>+98 21 8804 0060</telephone>
        <email>sobhani518@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of multi-root chronic lumbar radiculopathy by the diagnosis of the relevant specialist
Male and female sufferers between 30 and 50 years old
Body Mass Index (BMI) between 25 and 30</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Contraindications to the use of joint and nerve tissue mobilizations include severe osteoarthritis and other rheumatic diseases and blood circulation problems in the lumbar region, as well as damage to the nerves branching from the lumbar vertebrae such as severe sciatica (neurotmesis or axonotmesis).
Have a history of vertebral fracture in the lumbar region.
Have a history of Fixation and Laminectomy surgeries.
A patient with spondylolisthesis, malignancy, metabolic and internal problems
having cognitive problems and not being able to learn and perform physical therapy exercises
Patients with spinal deformities such as scoliosis, etc. should not be
Reluctance of people to continue testing.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neuritis or radiculitis:brachial NOSlumbar NOSlumbosacral NOSthoracic NOSRadiculitis NOSlumbar and other intervertebral disc disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: routine physiotherapy (electrotherapy including the use of ultrasound devices, tennis currents, infrared rays, and therapeutic exercise including isometric contraction of paravertebral muscles, diaphragmatic, mobility, McKenzie and Williams method) and massage which is performed during 10 sessions, including 3 sessions of 1 hour each week</i_keyword>
      <i_keyword>Intervention group: Mulligan vertebral mobilization with routine physical  therapy That is, only Mulligan vertebral mobilization is added to the treatment content of the control group that was mentioned with the same conditions of duration of sessions and treatment program. Mulligan Vertebral Mobilization is a method under manual therapy that manipulates the vertebrae of the spine with or without movement of the lower limbs, where the method of manipulating the vertebrae in the appropriate direction of flexion or extension using the movement of the lower limbs is about 15 minutes. It will be added to the routine treatment in each session.</i_keyword>
      <i_keyword>Intervention group: Nerve mobilization along with routine physiotherapy That is, to the treatment content of the control group that was mentioned, with the same conditions of the duration of the sessions and treatment program, only nerve mobilization is added.Nerve mobilization is a method of manual therapy that uses the movement of the joints, the body is placed in positions that cause shortening and lengthening of the nerves branched from nerve networks such as femoral and sciatic, etc., which have anti-inflammatory effects and It has pain relief and in this group, 15 minutes will be added to the routine treatment for each session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability score in Oswestry questionnaire. Timepoint: The beginning of the study and the end of 10 physiotherapy sessions (20 days after the start of the study). Method of measurement: Questionnaire of oswestry disability index.</prim_outcome>
      <prim_outcome>Disability score in Quebec questionnaire. Timepoint: The beginning of the study and the end of 10 physiotherapy sessions (20 days after the start of the study). Method of measurement: Questionnaire of Quebec back pain disability scale.</prim_outcome>
      <prim_outcome>Pain score. Timepoint: The beginning of the study and the end of 10 physiotherapy sessions (20 days after the start of the study). Method of measurement: Visual Analogue Scale.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-29</approval_date>
        <contact_name>Baqiyatullah-ul-Azam Medical Education Center (Ethics in Research Committee)</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
