<?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>IRCT20130409012953N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-29</date_registration>
      <primary_sponsor>Baqiyatallah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of lumbar mobilization, muscle energy technique, and slump stretching with exercise on low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of lumbar mobilization, muscle energy technique, and slump stretching with exercise in patients with non-specific low back pain: A randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30512</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible chronic non-specific low back pain participants will be randomly assigned to a mobilization (group 1), muscle energy technique (group 2), or a slump stretching (group 3) group with a ratio of 1:1:1. Randomization will be performed using a block-balanced randomization technique with 6 character blocks containing letters A, B, and C. After randomizing, the randomization schedule will be transferred into written instructions and will be placed in sequentially numbered, opaque, and sealed envelopes. The procedure will be performed by an investigator who will not be involved with participants assessment and treatment, Blinding description: In this study, outcomes assessor will not be informed about the intervention that chronic non-specific low back pain patients received during the treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain is defined as pain persisting for a period of greater than 3 months, localized between the costal margin and the inferior gluteal folds, without referred leg pain and that is not caused by a known specific pathology..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Lumbar spine postero-anterior mobilization and stabilization exercises- In this group, each participant will receive approximately 10 minutes of lumbar spine mobilization to the hypomobile segments identified during the initial examination. Each participant will be positioned in prone on a treatment table with a small pillow will be placed under the abdomen to enhance his/her comfort. A graded posterior–anterior mobilization (grade II and III) will be provided to the most provocative vertebral segment for three sets of 40-second oscillations. All other hypomobile lumbar segments will be mobilized for two sets of 40-second oscillations. Following mobilization, the participants will perform lumber stabilization exercise. Each participant will perform two sets of 10 repetitions of wall squat, bridge, pelvic tilt, and quadruped arm and leg lifts. Intervention 2: Intervention group 2: Muscle energy technique and stabilization exercises- The participant will sit upright on a treatment table with the hands resting on the opposite shoulders. The physical therapist will stand close to the participant and will ask him/her to perform lumbar flexion movement to the maximum available range. Then, the participant will be instructed to perform a submaximal isometric contraction (20-25% maximum voluntary isometric contraction) of the paraspinal muscles against the physical therapist resistive force and maintain this contraction for 5 seconds. Afterward, the participant will be asked to relax the contraction and the physical therapist will move the trunk into the new range. This technique will be repeated three time in each treatment session. Following muscle energy technique, the participants will perform lumber stabilization exercise. Each participant will perform two sets of 10 repetitions of wall squat, bridge, pelvic tilt, and quadruped arm and leg lifts. Intervention 3: Intervention group 3: Slump stretching and stabilization exercises- Slump stretching exercises will be provided by the physical therapist. The participant will be positioned in long sitting, feet against a wall to maintain neutral dorsiflexion angle, trunk will be flexed to enhance dural elongation, while the physical therapist will apply cervical overpressure to ensure a consistent pressure just at the onset of symptom provocation. Five repetitions of 30-second holds will be performed. Following slump stretching, the participants will perform lumber stabilization exercise. Each participant will perform two sets of 10 repetitions of wall squat, bridge, pelvic tilt, and quadruped arm and leg lifts.</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:
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary.

When:
Starting 6 months after publication

To whom:
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders

Conditions:
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain.

Where to obtain:
Applicants can contact Dr. Mohammad Reza Pourahmadi (PT, PhD) by email.
Email address: pourahmadipt@gmail.com

How to obtain:
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This 
 process may takes 10-12 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Pourahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4391-15875</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>pourahmadipt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Pourahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4391-15875</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>pourahmadipt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Low back pain persisting for more than 3 months in the absence of an underlying pathology
Aged between 18 and 40 years
No contraindication for exercise
No history of surgery in the lumbar region
No obvious scoliosis
No sensory and motor deficits in the lower extremities
No vertebral fracture
No severe discopathy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smoking
Any recent trauma to the musculoskeletal system such as bony, muscular, ligamentous, and soft tissue structures in the lower extremities and trunk that might interfere with the treatment
Body mass index above 30 kg/m2
Absence for 3 consecutive treatment sessions</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Lumbar spine postero-anterior mobilization and stabilization exercises- In this group, each participant will receive approximately 10 minutes of lumbar spine mobilization to the hypomobile segments identified during the initial examination. Each participant will be positioned in prone on a treatment table with a small pillow will be placed under the abdomen to enhance his/her comfort. A graded posterior–anterior mobilization (grade II and III) will be provided to the most provocative vertebral segment for three sets of 40-second oscillations. All other hypomobile lumbar segments will be mobilized for two sets of 40-second oscillations. Following mobilization, the participants will perform lumber stabilization exercise. Each participant will perform two sets of 10 repetitions of wall squat, bridge, pelvic tilt, and quadruped arm and leg lifts.</i_keyword>
      <i_keyword>Intervention group 2: Muscle energy technique and stabilization exercises- The participant will sit upright on a treatment table with the hands resting on the opposite shoulders. The physical therapist will stand close to the participant and will ask him/her to perform lumbar flexion movement to the maximum available range. Then, the participant will be instructed to perform a submaximal isometric contraction (20-25% maximum voluntary isometric contraction) of the paraspinal muscles against the physical therapist resistive force and maintain this contraction for 5 seconds. Afterward, the participant will be asked to relax the contraction and the physical therapist will move the trunk into the new range. This technique will be repeated three time in each treatment session. Following muscle energy technique, the participants will perform lumber stabilization exercise. Each participant will perform two sets of 10 repetitions of wall squat, bridge, pelvic tilt, and quadruped arm and leg lifts.</i_keyword>
      <i_keyword>Intervention group 3: Slump stretching and stabilization exercises- Slump stretching exercises will be provided by the physical therapist. The participant will be positioned in long sitting, feet against a wall to maintain neutral dorsiflexion angle, trunk will be flexed to enhance dural elongation, while the physical therapist will apply cervical overpressure to ensure a consistent pressure just at the onset of symptom provocation. Five repetitions of 30-second holds will be performed. Following slump stretching, the participants will perform lumber stabilization exercise. Each participant will perform two sets of 10 repetitions of wall squat, bridge, pelvic tilt, and quadruped arm and leg lifts.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 3, 6 sessions after intervention. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Lumbar spine flexion and extension range of motion. Timepoint: Before intervention and 3, 6 sessions after intervention. Method of measurement: Smartphone application (iHandy level).</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before intervention and 3, 6 sessions after intervention. Method of measurement: Persian version of Roland-Morris Disability Questionnaire and Oswestry Disability Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear avoidance beliefs. Timepoint: Before intervention and 3, 6 sessions after intervention. Method of measurement: Persian version of fear-avoidance beliefs questionnaire.</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>Baqiyatallah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-14</approval_date>
        <contact_name>The Ethics committee at the Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Exercise Physiology Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, South Sheykh Bahayi Street, Molasadra blvd, Vanak Sq, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
