<?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>IRCT20210803052062N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-31</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Resistance exercise for back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of trunk muscle stabilization exercise and Williams exercise on choronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57889</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups. For this purpose, 90 pieces of paper with the same shape and color are prepared. The number one is written on 45 prepared papers and the number two is written on the other 45 papers. Number one is considered for patients who do trunk muscle stabilization exercise and number 2 is considered for patients who do Williams exercises. Then all the papers are placed in a box. After the patient's visit, the papers are taken out one by one until the sample size is complete.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patient is instructed to perform 5 exercises including elbow-toe, hand-knee, curl-up, side side, and back bridge as follows on the floor or a stable surface. For doing elbow-toe the subject was instructed to maintain a prone plank position on the floor, such that the elbows were beneath the shoulders and the upper arms were perpendicular to the floor. In this position, only the toes and forearms were touching the floor. Back Bridge The subject was supine on the floor, with feet flat on the ground, knees bent at 90°, toes facing forwards, and hands on the floor by the sides, palms facing down. The subject raised the pelvis to achieve and maintain a neutral hip flexion angle. Hand-Knee The subject assumed a quadruped position and was asked to hold a neutral pelvis position as well as to breathe normally. The subject then lifted the right upper extremity and held it straight, while simultaneously lifting the left lower extremity and holding it straight also. Side Bridge The subject was positioned in right sidelying, with the right elbow directly beneath the shoulder and upper arm perpendicular to the ground. The subject raised the pelvis so that the spine was straight, thereby achieving a position supported only by the right elbow and the side of the right foot. Curl-up the subject was supine, with hips at 45° and knees at 90° and hands behind the head. The subject tucked in chin and curled the upper trunk by lifting the thoracic spine off the floor. With the exercise performed optimally, the curl up was performed so that the scapulae were off the floor. Once in this position, the subject was asked to breathe deeply. After training, and ensuring that the exercises are done correctly, patients do these exercises three times a day, three days a week for eight weeks. Intervention 2: Control group: The patient is instructed to perform 5 exercises including pelvic tilt exercises, partial sit-ups, knee-to-chest, hamstring stretching, Standing lumbar flexion. To perform pelvic tilt exercises, patient lie on back with knees bent, feet flat on floor. Then flatten the back against the floor, without pushing down with the legs. To perform Partial sit-ups patient lies supine with knees bent and feet flat on floor. With hands behind his or her head, elevates the upper torso until the scapulae clear the resting surface and stress is placed on the rectus abdominus. To perform knee-to-chest lie on his back with knees bent and feet flat on the floor. Then slowly pull right knee toward your and hold 5 to 10 seconds, lower the knee and repeat with the other knee. To perform a hamstring stretch, patient sits with the knees extension and side by side. Then raises the upper limbs parallel to the lower limbs and pushes the trunk forward and toward the legs and holds for 5 seconds. To perform standing lumbar flexion patient Stand upright with feet spread shoulder width apart. Slowly bend forward, sliding hands down legs, until he/she feels tension in the back. After training, and ensuring that the exercises are done correctly, patients do these exercises three times a day, three days a week for eight weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because I do not have any experience in this field</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamdollah Delaviz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No 22, Bahonar 1 avenue</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591951176</zip>
        <telephone>+98 74 3323 6302</telephone>
        <email>delavizhamdi83@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamdollah Delaviz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No 22, Bahonar 1 avenue</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591951176</zip>
        <telephone>+98 74 3323 6302</telephone>
        <email>delavizhamdi83@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age 35 and maximum 65 years old
At least 3 months have passed since the person had low back pain
Chronic back pain should be confirmed by an orthopedic specialist</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>56 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of surgery or fractures in the spine
Use walking aids
Movement restriction in the lower limbs
Pressure on nerve roots
Spinal canal stenosis,
Presence of intervertebral disc herniation
Presence of spondylolisthesis,
Presence of severe cardiovascular disease or metabolic disease
Suffering from mental illness
Use of anticonvulsant drugs</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The patient is instructed to perform 5 exercises including elbow-toe, hand-knee, curl-up, side side, and back bridge as follows on the floor or a stable surface. For doing elbow-toe the subject was instructed to maintain a prone plank position on the floor, such that the elbows were beneath the shoulders and the upper arms were perpendicular to the floor. In this position, only the toes and forearms were touching the floor. Back Bridge The subject was supine on the floor, with feet flat on the ground, knees bent at 90°, toes facing forwards, and hands on the floor by the sides, palms facing down. The subject raised the pelvis to achieve and maintain a neutral hip flexion angle. Hand-Knee The subject assumed a quadruped position and was asked to hold a neutral pelvis position as well as to breathe normally. The subject then lifted the right upper extremity and held it straight, while simultaneously lifting the left lower extremity and holding it straight also. Side Bridge The subject was positioned in right sidelying, with the right elbow directly beneath the shoulder and upper arm perpendicular to the ground. The subject raised the pelvis so that the spine was straight, thereby achieving a position supported only by the right elbow and the side of the right foot. Curl-up the subject was supine, with hips at 45° and knees at 90° and hands behind the head. The subject tucked in chin and curled the upper trunk by lifting the thoracic spine off the floor. With the exercise performed optimally, the curl up was performed so that the scapulae were off the floor. Once in this position, the subject was asked to breathe deeply. After training, and ensuring that the exercises are done correctly, patients do these exercises three times a day, three days a week for eight weeks.</i_keyword>
      <i_keyword>Control group: The patient is instructed to perform 5 exercises including pelvic tilt exercises, partial sit-ups, knee-to-chest, hamstring stretching, Standing lumbar flexion. To perform pelvic tilt exercises, patient lie on back with knees bent, feet flat on floor. Then flatten the back against the floor, without pushing down with the legs. To perform Partial sit-ups patient lies supine with knees bent and feet flat on floor. With hands behind his or her head, elevates the upper torso until the scapulae clear the resting surface and stress is placed on the rectus abdominus. To perform knee-to-chest lie on his back with knees bent and feet flat on the floor. Then slowly pull right knee toward your and hold 5 to 10 seconds, lower the knee and repeat with the other knee. To perform a hamstring stretch, patient sits with the knees extension and side by side. Then raises the upper limbs parallel to the lower limbs and pushes the trunk forward and toward the legs and holds for 5 seconds. To perform standing lumbar flexion patient Stand upright with feet spread shoulder width apart. Slowly bend forward, sliding hands down legs, until he/she feels tension in the back. After training, and ensuring that the exercises are done correctly, patients do these exercises three times a day, three days a week for eight weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean pain intensity. Timepoint: Before treatment and 4 weeks and 8 weeks after treatment. Method of measurement: Based on visual analog scale.</prim_outcome>
      <prim_outcome>Mean Disability Index. Timepoint: Before treatment and 4 weeks and 8 weeks after treatment. Method of measurement: Based  on Oswestry disability index (ODI).</prim_outcome>
      <prim_outcome>Mean Lumbar functional index. Timepoint: Before treatment and 4 weeks and 8 weeks after treatment. Method of measurement: Base on Lumbar functional index.</prim_outcome>
      <prim_outcome>Mean Fingertip-to-Floor distance. Timepoint: Before treatment and 4 weeks and 8 weeks after treatment. Method of measurement: Based on Fingertip-to-Floor Test.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-02</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Unit 1, No 22, Bahonar1 avenue Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
