<?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>IRCT20230212057390N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the immediate effect of abdominal muscle massage in non-acute back pain patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the immediate effect of abdominal muscle massage with lumbar muscle massage in non-acute back pain patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will use the block randomization method to generate a sequence of random numbers. In this method, 15 blocks of size 4 and 7 blocks of size two will be randomly selected from the combination of letters A and B with the table of random numbers.
The list of blocks with size two are 1:AB, 2:BA and the list of blocks with size four are 1:AABB, 2:ABBA, 3:BBAA, 4:BAAB, 5:BABA, 6:ABAB
To select blocks of size 2, 7 numbers randomly from the table of random numbers are selected; if this number is from 0 to 4, the first block, and if the number is from 5 to 9, the second block will be selected.
To select blocks of size 4, randomly 15 numbers between 1 to 6 will be selected from the table of random numbers; then, if this number is one, the first block of size four, and if the selected number is 2, the second block of size four and ..., will form our random sequence.
After determining the random sequence, each person's type of treatment is placed in sealed envelopes, and referring patients, if they meet the criteria for entering the study, will receive their type of treatment based on the sequence obtained.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non acute mechanical low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the abdominal muscles include rectus abdominis, paramedialis, and oblique abdominal muscles. The mentioned techniques are performed in the posture of archer and palmer. The treated muscles for the lumbar region are Quaratus Lumbrum, Erector Spine, Multifidus, and Rotators. The patient sleeps in a supine position in the abdominal muscle massage group. He is lying on his back. The therapist stands next to the client in the hip area. Place one hand flat on the upper abdomen near the chest, pass the other hand over the first hand, and place it on the lower abdomen on the other side (fingers on the ASIS). Let the hands sink into the tissue until they are involved with the superficial fascia of the abdomen. Separate the hands without letting them slide over the skin. Hold for release. Repeat on the opposite side. 3 minutes 3) The patient is lying on his back. The therapist stands next to the client in the pelvic area. Fingertips were placed on one side of the rectus abdominis muscle just above the pubic bone. Pressing firmly into the tissue, pull the fingertips upwards along the muscle towards the rib attachment. Repeat the same procedure on the other side. 3) The client is lying on his back. The therapist stands next to the client in the pelvic area. Place the supported thumb on the lateral border of the rectus abdominis muscle. Above the genital area, by pressing firmly on the tissue, slide the thumb along the muscle towards the upper joints on the muscle. Repeat the same procedure on the other side. 5 minutes 4) The client is lying on his back. The therapist stands next to the chest. Place the supported thumb at the junction of the ventral line with the pubis on the side closest to the therapist. Press the muscle firmly against the bone and look for tender points. Hold for freedom. Move the hand towards the middle to the next point and repeat this until the hand reaches the line in the center. Repeat this procedure on the other side. 5) The client is lying on his back. The therapist stands next to the lumbar region. Place the thumb tip on the rectus abdominis in the midline (middle line) just above the pubic area. Pushing firmly into the tissue, slide the thumb tip laterally toward the fingertips and prick. Repeat this procedure, starting just above the previous point. Repeat the same procedure along the abdominal line until reaching the chest. Repeat this procedure on the other side. 6) The patient sleeps prone. We stand next to the patient's chest. We repeat this technique on the opposite side until it covers the entire surface of the abdomen. Intervention 2: Control group: In the posterior muscle massage, first, the patient lies on his back for three minutes, and 3 bilateral superficial strokes are performed in the warm-up phase. 2) The therapist stands next to the participant's chest. Place the lumbar region next to the vertebrae on the iliac crest next to the sacrum bone. Pass the other hand over or under the first hand, placing it flat on the chest area over the lower three or four ribs, letting the hands sink into the tissue until it felt contact with the superficial fascia. Press in the opposite direction, with enough downward pressure to stretch the superficial fascia. The therapist maintained the pressure until it felt the release of the fascia. Place both hands one hand's width apart for three minutes, and this technique 3) The patient sleeps prone, and the therapist stands next to the hip (to work in the upward direction). Place the heel of the hand on the erector spinae muscle bundle near the sacrum. By pressing firmly on the tissue, slide along the entire length of the muscle 3) The patient lies prone. The therapist stands next to the client's chest. We press the tips of the fingers or the supported thumb in the upper part of the sacrum and the lateral vertebrae firmly downward and outward inside the tissue and let it slide. Repeat this technique on the other side as well. For 5 minutes 4) The patient sleeps on his back. The therapist stands next to the client's back. Place the thumb or the tip of the finger (with or without support) on the space between the L5 vertebra and the sacrum. Apply lateral pressure (away from you); push the superficial muscles aside to reach the internal muscles. If the patient reports tenderness, hold the pressure to release. The therapist moved the hand and applied the technique between the upper two vertebrae. Repeat for three minutes until the 12th thoracic vertebra and the first lumbar vertebra. 5) Ischemic compression in painful points. Ischemic compression is applied in different ways to release trigger points and relax hypertonic areas. The thumb is used in the quadratus lumborum and around the sacroiliac joint. The quadratus lumborum is also pressed by the elbow.</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 Information will be provided to the journal if needed and requested by the journal.</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>Patients with non-acute mechanical back pain
Disability level greater than 15% based on Oswestry modified questionnaire
Presence of pain during at least one physiological movement of the back</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>RED flag patients, including malignancy, infection, fracture
Patients who need surgery
Pregnant patients
Skin problems in patients5.
Patients who are prohibited from massaging the abdominal area for any reason, such as patients with a recent history of abdominal obstruction, radiotherapy, and recent abdominal surgery, inflammatory bowel disease, or irritable bowel syndrome.
Patients with acute back pain they cannot stand and perform tests.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>due to intervertebral disc displacement</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: In this study, the abdominal muscles include rectus abdominis, paramedialis, and oblique abdominal muscles. The mentioned techniques are performed in the posture of archer and palmer. The treated muscles for the lumbar region are Quaratus Lumbrum, Erector Spine, Multifidus, and Rotators. The patient sleeps in a supine position in the abdominal muscle massage group. He is lying on his back. The therapist stands next to the client in the hip area. Place one hand flat on the upper abdomen near the chest, pass the other hand over the first hand, and place it on the lower abdomen on the other side (fingers on the ASIS). Let the hands sink into the tissue until they are involved with the superficial fascia of the abdomen. Separate the hands without letting them slide over the skin. Hold for release. Repeat on the opposite side. 3 minutes 3) The patient is lying on his back. The therapist stands next to the client in the pelvic area. Fingertips were placed on one side of the rectus abdominis muscle just above the pubic bone. Pressing firmly into the tissue, pull the fingertips upwards along the muscle towards the rib attachment. Repeat the same procedure on the other side. 3) The client is lying on his back. The therapist stands next to the client in the pelvic area. Place the supported thumb on the lateral border of the rectus abdominis muscle. Above the genital area, by pressing firmly on the tissue, slide the thumb along the muscle towards the upper joints on the muscle. Repeat the same procedure on the other side. 5 minutes 4) The client is lying on his back. The therapist stands next to the chest. Place the supported thumb at the junction of the ventral line with the pubis on the side closest to the therapist. Press the muscle firmly against the bone and look for tender points. Hold for freedom. Move the hand towards the middle to the next point and repeat this until the hand reaches the line in the center. Repeat this procedure on the other side. 5) The client is lying on his back. The therapist stands next to the lumbar region. Place the thumb tip on the rectus abdominis in the midline (middle line) just above the pubic area. Pushing firmly into the tissue, slide the thumb tip laterally toward the fingertips and prick. Repeat this procedure, starting just above the previous point. Repeat the same procedure along the abdominal line until reaching the chest. Repeat this procedure on the other side. 6) The patient sleeps prone. We stand next to the patient's chest. We repeat this technique on the opposite side until it covers the entire surface of the abdomen.</i_keyword>
      <i_keyword>Control group: In the posterior muscle massage, first, the patient lies on his back for three minutes, and 3 bilateral superficial strokes are performed in the warm-up phase. 2) The therapist stands next to the participant's chest. Place the lumbar region next to the vertebrae on the iliac crest next to the sacrum bone. Pass the other hand over or under the first hand, placing it flat on the chest area over the lower three or four ribs, letting the hands sink into the tissue until it felt contact with the superficial fascia. Press in the opposite direction, with enough downward pressure to stretch the superficial fascia. The therapist maintained the pressure until it felt the release of the fascia. Place both hands one hand's width apart for three minutes, and this technique 3) The patient sleeps prone, and the therapist stands next to the hip (to work in the upward direction). Place the heel of the hand on the erector spinae muscle bundle near the sacrum. By pressing firmly on the tissue, slide along the entire length of the muscle 3) The patient lies prone. The therapist stands next to the client's chest. We press the tips of the fingers or the supported thumb in the upper part of the sacrum and the lateral vertebrae firmly downward and outward inside the tissue and let it slide. Repeat this technique on the other side as well. For 5 minutes 4) The patient sleeps on his back. The therapist stands next to the client's back. Place the thumb or the tip of the finger (with or without support) on the space between the L5 vertebra and the sacrum. Apply lateral pressure (away from you); push the superficial muscles aside to reach the internal muscles. If the patient reports tenderness, hold the pressure to release. The therapist moved the hand and applied the technique between the upper two vertebrae. Repeat for three minutes until the 12th thoracic vertebra and the first lumbar vertebra. 5) Ischemic compression in painful points. Ischemic compression is applied in different ways to release trigger points and relax hypertonic areas. The thumb is used in the quadratus lumborum and around the sacroiliac joint. The quadratus lumborum is also pressed by the elbow.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain with the visual analog scale during back movements. Timepoint: Immediately before and after the intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion lumbar. Timepoint: Immediately before and after the intervention. Method of measurement: With two bubble inclinometer.</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>2022-05-29</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی مشهد</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>
