<?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>IRCT20230411057885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-15</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of virtual reality therapeutic exercise in the treatment of chronic low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of performing therapeutic selected exercises using virtual reality and routine method on pain, function and quality of life in patients with non-specific chronic low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69572</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Placement of samples in intervention and control groups is done in a simple random stratified manner. Considering that it is necessary for the groups to be homogeneous in terms of sex, the classes include 2 classes resulting from the sex (two groups). A person is placed in one of the classes based on gender. The desired sample is then randomly placed in one of the two groups, and the next sample placed in the same class is placed in the opposite group, Blinding description: The evaluator of patients participating in the first session and the final 10th session is blinded to the information, purpose and results of the thesis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patients suffering chronic non specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  It should be noted that all patients are placed in the lying position on the stomach during all stages of using the modalities and a pillow is placed under the abdomen and leg. The spine should be in a neutral position. Using a small towel under the patient's forehead will be used to prevent neck rotation. Applying ten sessions of physiotherapy using modalities that include three modalities. which includes three modalities: 1) Continuous ultrasound with a frequency of 3 MHz for 8 minutes. The application of pulsed ultrasound was standardized in the lower back area between the first and fifth lumbar vertebra and in the area of ​​interest, the distance between the spinous and transverse appendages on the right and left sides, the target muscles including the spinalis, the erector spinae muscles and in the multifidus area, which is below the two The mentioned muscle is located. One minute was considered for each point, after the electric current of TENS continuously in the lower back area in the pain area for 15 minutes using two channels and four electrodes (10 x 10 cm) placed around the pain area with Frequency setting of 20 Hz and pulse width of 10 pulses per second (pps) along with 15 minutes of our infrared heat is used at a distance of 30 cm on the lower back area. The next step, which is the exercise step, first teaches the patient how to perform each exercise. Each exercise mentioned is repeated ten times. The red reference is placed in the middle of the patient's foot, and the ball is displayed at a certain distance from the red marker when it is shown on either side of the patient. The patient is placed individually (alone) with the therapist in a room dedicated to virtual reality and face to face with a distance of 200-250 cm from the device. The progress of the exercises will be done depending on the patient's ability during the sessions. Intervention 2: Control group: It should be noted that all patients are placed in the lying position on the stomach during all stages of using the modalities and a pillow is placed under the abdomen and leg. The spine should be in a neutral position. Using a small towel under the patient's forehead will be used to prevent neck rotation. Applying ten sessions of physiotherapy using modalities that include three modalities. which includes three modalities: 1) Continuous ultrasound with a frequency of 3 MHz for 8 minutes. The application of pulsed ultrasound was standardized in the lower back area between the first and fifth lumbar vertebra and in the area of ​​interest, the distance between the spinous and transverse appendages on the right and left sides, the target muscles including the spinalis, the erector spinae muscles and in the multifidus area, which is below the two The mentioned muscle is located. One minute was considered for each point, after the electric current of TENS continuously in the lower back area in the pain area for 15 minutes using two channels and four electrodes (10 x 10 cm) placed around the pain area with Frequency setting of 20 Hz and pulse width of 10 pulses per second (pps) along with 15 minutes of our infrared heat is used at a distance of 30 cm on the lower back area.The next step, which is the exercise step, first teaches the patient how to perform each exercise. Each exercise mentioned is repeated five times in the first session, and increased to 10 repetitions in the second session, 15 repetitions in the third session, and 20 repetitions in the fourth session. The remaining sessions are continued with 20 repetitions. The exercises of the control and intervention groups have been selected in such a way that they can be implemented in a similar and corresponding way in each group, with the difference that in the intervention group, the exercises are performed using a virtual reality system.</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:
demographic information and outcomes

When:
6 months after article acceptance

To whom:
other researchers

Conditions:
more advanced researches like meta analysis

Where to obtain:
fatimah nader khalifeh 09334545341 fatimah.khalifeh@hotmail.com

How to obtain:
university of rehabilitation and social welfare sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatimah Khalifeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Aghdasiye street , sadr nejad street , sahel end , boustan compound , block 1 plak 6</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 933 454 5341</telephone>
        <email>fatimah.khalifeh@hotmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noureddin Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin , daneshju blvd, kodakyar ave, university of rehabilitation and social welfare sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>0989122573865</telephone>
        <email>karimi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with non-specific chronic mechanical back pain with the diagnosis of the attending physician and file.
People who are between 20-50 years old.
They are not involved in any other treatment program during the study.
Have stopped taking painkillers 24 hours before the evaluation.
Having a history of back pain for at least 12 weeks.
Have an average pain of 4-7 on the visual analog scale of pain in the previous seven days.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with congenital abnormalities.
History of trauma
Fracture of the spine or lower and upper limbs
Any systemic disease or neurological disease
Individuals who have taken corticosteroids, benzodiazepines, antidepressants, or anticonvulsants three weeks prior to the evaluation.
pregnant women
previous back surgeries
Vestibular and vision disorders
Obese people according to body mass index
Aggravation of symptoms so that it is not possible to perform.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dorsalgia, unspecified</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:  It should be noted that all patients are placed in the lying position on the stomach during all stages of using the modalities and a pillow is placed under the abdomen and leg. The spine should be in a neutral position. Using a small towel under the patient's forehead will be used to prevent neck rotation. Applying ten sessions of physiotherapy using modalities that include three modalities. which includes three modalities: 1) Continuous ultrasound with a frequency of 3 MHz for 8 minutes. The application of pulsed ultrasound was standardized in the lower back area between the first and fifth lumbar vertebra and in the area of ​​interest, the distance between the spinous and transverse appendages on the right and left sides, the target muscles including the spinalis, the erector spinae muscles and in the multifidus area, which is below the two The mentioned muscle is located. One minute was considered for each point, after the electric current of TENS continuously in the lower back area in the pain area for 15 minutes using two channels and four electrodes (10 x 10 cm) placed around the pain area with Frequency setting of 20 Hz and pulse width of 10 pulses per second (pps) along with 15 minutes of our infrared heat is used at a distance of 30 cm on the lower back area. The next step, which is the exercise step, first teaches the patient how to perform each exercise. Each exercise mentioned is repeated ten times. The red reference is placed in the middle of the patient's foot, and the ball is displayed at a certain distance from the red marker when it is shown on either side of the patient. The patient is placed individually (alone) with the therapist in a room dedicated to virtual reality and face to face with a distance of 200-250 cm from the device. The progress of the exercises will be done depending on the patient's ability during the sessions.</i_keyword>
      <i_keyword>Control group: It should be noted that all patients are placed in the lying position on the stomach during all stages of using the modalities and a pillow is placed under the abdomen and leg. The spine should be in a neutral position. Using a small towel under the patient's forehead will be used to prevent neck rotation. Applying ten sessions of physiotherapy using modalities that include three modalities. which includes three modalities: 1) Continuous ultrasound with a frequency of 3 MHz for 8 minutes. The application of pulsed ultrasound was standardized in the lower back area between the first and fifth lumbar vertebra and in the area of ​​interest, the distance between the spinous and transverse appendages on the right and left sides, the target muscles including the spinalis, the erector spinae muscles and in the multifidus area, which is below the two The mentioned muscle is located. One minute was considered for each point, after the electric current of TENS continuously in the lower back area in the pain area for 15 minutes using two channels and four electrodes (10 x 10 cm) placed around the pain area with Frequency setting of 20 Hz and pulse width of 10 pulses per second (pps) along with 15 minutes of our infrared heat is used at a distance of 30 cm on the lower back area.The next step, which is the exercise step, first teaches the patient how to perform each exercise. Each exercise mentioned is repeated five times in the first session, and increased to 10 repetitions in the second session, 15 repetitions in the third session, and 20 repetitions in the fourth session. The remaining sessions are continued with 20 repetitions. The exercises of the control and intervention groups have been selected in such a way that they can be implemented in a similar and corresponding way in each group, with the difference that in the intervention group, the exercises are performed using a virtual reality system.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score that is calculated between 0 and 10. Timepoint: Measuring the pain score before the intervention and at the end of the treatment sessions and two weeks later. Method of measurement: using the virtual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Kinesiophobia. Timepoint: before the intervention and at the end of the treatment sessions and two weeks later. Method of measurement: tampa scale of kinesiophobia.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-19</approval_date>
        <contact_name>Ethical committee of rehabilitation and social welfare sciences university</contact_name>
        <contact_address>velenjak , daneshju boulevard, kodakyar ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
