<?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>IRCT20250531065987N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Mulligan technique with conventional physical therapy on the treatment of patients with lumbar disc herniation.</public_title>
      <acronym>SNAG</acronym>
      <scientific_title>The effect of Mulligan`s SNAG with conventional Physical Therapy Treatment on Pain, Disability, Kinematic and Coordination Between Lumbar Spine and Hip Joint during sit to stand and vice versa in People with Lumbar Discopathy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, to maintain balance between the two groups regarding the influential variable, stratified block randomization will be used. Participants will first be stratified based on gender, and then randomly assigned to two equal-sized groups: the intervention group (receiving the Mulligan mobilization technique along with conventional physiotherapy) and the control group (receiving conventional physiotherapy alone). The advantage of this method is that it not only ensures an equal number of participants in both groups, but also guarantees an even distribution of the stratifying variable across the groups.
The block size will be 4, with two participants in each block allocated to the intervention group and two to the control group. Allocation concealment will be ensured using sealed opaque envelopes. Each envelope will be labeled with a number corresponding to the total number of blocks. A person who is blinded to the study protocol will use a computer-generated random number sequence to select an envelope. The number on the envelope will be matched, the envelope opened, and the predefined block inside will determine the group allocation for four participants.
To minimize selection bias, the randomization procedure will be conducted by an independent person who will not be involved in any other aspect of the study, Blinding description: Participants in the study will be blinded to their group allocation. The researcher will organize the treatment sessions in such a way that the two groups will not have any contact with each other during the intervention period. All patient assessments, including pain intensity, disability level, and kinematic evaluations, will be conducted by an independent assessor who is not involved in the treatment of participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>lumbar discopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will undergo a treatment program consisting of conventional physiotherapy combined with the Mulligan Sustained Natural Apophyseal Glide (SNAG) technique. The intervention will be delivered over 10 sessions, scheduled three times per week for four consecutive weeks. The treatment protocol includes the following components:1. Superficial heat therapy applied for 15 minutes per session.2. Superficial electrical stimulation administered for 15 minutes per session.3. Motor control exercises, including activation and training of the pelvic floor muscles, transverse abdominis, and multifidus. These exercises will start in the supine position and will gradually progress to sitting, standing, and functional positions, in accordance with the patient’s ability and progression.4.General education and advice: Patients will receive a brief explanation of the pathoanatomical nature of their condition and its prognosis. They will also be advised to maintain daily activities, avoid movements or tasks that may aggravate symptoms, and follow general self-management principles.5. Home exercise program: Patients will be instructed to perform a set of prescribed exercises at home for 30 minutes per day. Visual instructions will be provided, and patients will be asked to track their daily performance by marking completed exercises on a log sheet.Finally, the SNAG technique will be applied by the therapist in sitting and standing positions, beginning with three repetitions in the first session, progressing to ten repetitions in subsequent sessions. Intervention 2: Control group: Participants in the control group will receive conventional physiotherapy alone over 10 sessions, conducted three times per week for a total duration of four weeks. The treatment components include:1. Superficial heat therapy applied for 15 minutes per session.2. Superficial electrical stimulation administered for 15 minutes per session.3. Motor control exercises, targeting the pelvic floor muscles, transverse abdominis, and multifidus. These exercises will begin in the supine position and will progressively advance to sitting, standing, and functional positions, based on patient tolerance and progression.4. General advice and education, including a description of the pathoanatomical basis of the condition, discussion of the prognosis, and recommendations to maintain daily activity levels while avoiding aggravating movements.5. Home exercise program: Patients will be asked to perform prescribed exercises at home for 30 minutes daily. They will be provided with illustrated instructions, and will be instructed to check off each exercise performed daily as a part of adherence monitoring.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not yet decided on the method of its publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Jannati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences** Madadkaran St., Shah Nazari St., Madar Square, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>elhamjannati@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Jannati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Madadkaran St., Shah Nazari St., Madar Square, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>elhamjannati@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pain intensity between 3 and 7 on the Visual Analog Scale (between 3 and 7 inclusive)
MRI or CT scan findings indicating disc protrusion at L4-L5-S1 levels
Patients most have a directional preference for lumbar spine extension
Low back pain that is aggravated by prolonged sitting or repeated flexion of the lumbar spine
A positive result in at least one of the SLR or SLUMP tests
The duration of pain and related symptoms between 6 weeks and 6 months</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of neurological signs such as altred reflexes, dermatomal sensory deficits, or myotomal weakness
A pathoanatomic cause of radiculopathy other than disc herniation(on MRI)
Spinal stenosis
Spinal tumor
Spondylolisthesis
Serious pathologies such as malignancy, cauda equina syndrom, and foot drop
Pregnancy or childbirth within the previous 6 month
History of corticostroid injection within the last 6 weeks
History of spinal injury
Presence of significant hamstring tightness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Radiculopathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the intervention group will undergo a treatment program consisting of conventional physiotherapy combined with the Mulligan Sustained Natural Apophyseal Glide (SNAG) technique. The intervention will be delivered over 10 sessions, scheduled three times per week for four consecutive weeks. The treatment protocol includes the following components:1. Superficial heat therapy applied for 15 minutes per session.2. Superficial electrical stimulation administered for 15 minutes per session.3. Motor control exercises, including activation and training of the pelvic floor muscles, transverse abdominis, and multifidus. These exercises will start in the supine position and will gradually progress to sitting, standing, and functional positions, in accordance with the patient’s ability and progression.4.General education and advice: Patients will receive a brief explanation of the pathoanatomical nature of their condition and its prognosis. They will also be advised to maintain daily activities, avoid movements or tasks that may aggravate symptoms, and follow general self-management principles.5. Home exercise program: Patients will be instructed to perform a set of prescribed exercises at home for 30 minutes per day. Visual instructions will be provided, and patients will be asked to track their daily performance by marking completed exercises on a log sheet.Finally, the SNAG technique will be applied by the therapist in sitting and standing positions, beginning with three repetitions in the first session, progressing to ten repetitions in subsequent sessions.</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive conventional physiotherapy alone over 10 sessions, conducted three times per week for a total duration of four weeks. The treatment components include:1. Superficial heat therapy applied for 15 minutes per session.2. Superficial electrical stimulation administered for 15 minutes per session.3. Motor control exercises, targeting the pelvic floor muscles, transverse abdominis, and multifidus. These exercises will begin in the supine position and will progressively advance to sitting, standing, and functional positions, based on patient tolerance and progression.4. General advice and education, including a description of the pathoanatomical basis of the condition, discussion of the prognosis, and recommendations to maintain daily activity levels while avoiding aggravating movements.5. Home exercise program: Patients will be asked to perform prescribed exercises at home for 30 minutes daily. They will be provided with illustrated instructions, and will be instructed to check off each exercise performed daily as a part of adherence monitoring.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain: according to the definition by the International Association for the Study of Pain, pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. There is no fully objective method for measuring pain, and it is often assessed through subjective approaches. Timepoint: Before the intervention, after the completion of ten intervention sessions, and one month after the end of the intervention. Method of measurement: In this study, the intensity of patients' pain will be measured using the Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Disability: is defined as the inability or limitation in performing tasks and engaging in activities that are expected from an individual in specific social roles. These may include personal care, household chores, employment, and social interaction. Timepoint: Before the intervention, after the completion of ten intervention sessions, and one month after the end of the intervention. Method of measurement: The Persian-translated and culturally adapted version of the Oswestry Disability Index (ODI) was used to assess disability.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion: is defined as the extent of relative movement or positional change occurring between two or more anatomically connected body segments. Timepoint: Assessments were conducted before the start and after the completion of 10 intervention sessions. Method of measurement: This study will measure the degree of flexion and the displacement of the lumbar spine segments and the hip joint using a three-dimensional motion analysis device.</sec_outcome>
      <sec_outcome>Continuous Relative Phase: represents the phase difference between two angular signals—such as those of the hip and lumbar joints—over time. It is derived from the combination of joint angle and angular velocity, ultimately reflecting the dynamic coordination pattern between two joints or body segments. Timepoint: Assessments were conducted before the start and after the completion of 10 intervention sessions. Method of measurement: It is calculated based on joint angle and angular velocity, which are assessed using a 3D motion analysis system.</sec_outcome>
      <sec_outcome>Lumbo-pelvic rhythm: refers to the relative pattern of contribution between the lumbar spine and the pelvis during trunk movement in the sagittal plane. Timepoint: Assessments were conducted before the start and after the completion of 10 intervention sessions. Method of measurement: In the present study, this value will be obtained by calculating the amount of lumbar spine movement relative to the movement of the right hip joint during the sit-to-stand and stand-to-sit tasks.</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>2025-05-25</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Central Headquarters, Iran University of Medical Sciences (IUMS), Hemmat Expressway, next to Milad Tower, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
