<?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>IRCT20210316050727N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-30</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of delivering low back exercises by an smartphone application and traditional methods in non-specific chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of delivering low back exercises by an smartphone application and traditional methods in non-specific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56940</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization, Random software allocation
For the allocation concealment, the type of intervention received is written on a piece of paper and placed inside the opaque envelopes and the back of the envelope will be numbered. The envelopes will be opened according to the entry of the participants and the type of group for each patient will be specified accordingly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The duration of interventions is 4 weeks with one month of follow-up. Patients are visited three times a week in the physiotherapy centers of the School of Rehabilitation and the interventions will be performed under the supervision of the project researchers. The duration of each exercise therapy session can vary depending on the stage of the treatment protocol and the number of exercises. Due to the difficulty of stabilizing exercises and the emphasis on doing the exercises correctly, patients in both groups are given a period of time to learn basic and basic exercises with the help of compression biofeedback, and then a 4-week treatment protocol with one month of follow-up. begins. In both groups, people first do some general stretching exercises to warm up before the main exercises; In the case of neurodynamic exercises, 4 exercises are considered that will be used only for patients with chronic low back pain who have pain referred to the lower extremities. Each neurodynamic exercise is performed one set of 20 per day. In the case of stabilization exercises, each exercise is held for 5 to 10 seconds and repeated 10 times a day (a set of ten). Each session adds one exercise to the patient's exercises so that in the first 4 weeks the patient receives all the relevant exercises and in the next 4 weeks repeats all the exercises; During this period, the number and timing of the exercises are improved. At the end of this section, the exercise schedule is set, but this schedule may change slightly depending on the patient's ability and skills. The patient is asked to do the exercises on a daily basis at home. Using the application in the treatment group is to examine the importance of using technology in the field of physiotherapy. In this regard, in order to prevent forgetfulness and doing wrong exercises in the application group, these exercises are provided to people through the application, which includes an instructional video of doing the exercises, teaching tips about back care, contacting the therapist, and sending a reminder message. Doing exercises and the message of doing or not doing exercises by the person is sent to the therapist through the application. Intervention 2: Control group: The duration of interventions is 4 weeks with one month of follow-up. Patients are visited three times a week in the physiotherapy centers of the School of Rehabilitation and the interventions will be performed under the supervision of the project researchers. The duration of each exercise therapy session can vary depending on the stage of the treatment protocol and the number of exercises. Due to the difficulty of stabilizing exercises and the emphasis on doing the exercises correctly, patients in both groups are given a period of time to learn basic and basic exercises with the help of compression biofeedback, and then a 4-week treatment protocol with one month of follow-up. begins. In both groups, people first do some general stretching exercises to warm up before the main exercises; In the case of neurodynamic exercises, 4 exercises are considered that will be used only for patients with chronic low back pain who have pain referred to the lower extremities. Each neurodynamic exercise is performed one set of 20 per day. In the case of stabilization exercises, each exercise is held for 5 to 10 seconds and repeated 10 times a day (a set of ten). Each session adds one exercise to the patient's exercises so that in the first 4 weeks the patient receives all the relevant exercises and in the next 4 weeks repeats all the exercises; During this period, the number and timing of the exercises are improved. At the end of this section, the exercise schedule is set, but this schedule may change slightly depending on the patient's ability and skills. The patient is asked to do the exercises on a daily basis at home. In the control group, the exercises and tips for taking care of the back are provided through a tutorial booklet with explanations and it is recommended to him to set phone alarm in order to not forget doing home exercises.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Soltani Somee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz, Tavanir, physiotherapy clinic of rehabilitation sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5355116553</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Ab.soltani@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Soltani Somee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz, Tavanir, physiotherapy clinic of rehabilitation sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5355116553</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Ab.soltani@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Low back pain patients aged 18-60 years who have had low back pain for more than 3 months, no specific cause for low back pain has been identified and physiotherapy has been prescribed.
Mild to moderate pain intensity (VAS 2 to 6 )
The Oswestry questionnaire score is above 10 before starting treatment.
Have at least one smartphone in the patient's family.
The person has the ability to read and understand the Persian language.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>cases such as infection and spinal tumors, osteoporosis and vertebral fractures
History of spinal surgery in the last 6 months
injury to the knee and ankle that restricts movement
People whose symptoms are reproduced at the beginning of the slump test during neck flexion
People with spinal deformities and ankylosing spondylitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 duration of interventions is 4 weeks with one month of follow-up. Patients are visited three times a week in the physiotherapy centers of the School of Rehabilitation and the interventions will be performed under the supervision of the project researchers. The duration of each exercise therapy session can vary depending on the stage of the treatment protocol and the number of exercises. Due to the difficulty of stabilizing exercises and the emphasis on doing the exercises correctly, patients in both groups are given a period of time to learn basic and basic exercises with the help of compression biofeedback, and then a 4-week treatment protocol with one month of follow-up. begins. In both groups, people first do some general stretching exercises to warm up before the main exercises; In the case of neurodynamic exercises, 4 exercises are considered that will be used only for patients with chronic low back pain who have pain referred to the lower extremities. Each neurodynamic exercise is performed one set of 20 per day. In the case of stabilization exercises, each exercise is held for 5 to 10 seconds and repeated 10 times a day (a set of ten). Each session adds one exercise to the patient's exercises so that in the first 4 weeks the patient receives all the relevant exercises and in the next 4 weeks repeats all the exercises; During this period, the number and timing of the exercises are improved. At the end of this section, the exercise schedule is set, but this schedule may change slightly depending on the patient's ability and skills. The patient is asked to do the exercises on a daily basis at home. Using the application in the treatment group is to examine the importance of using technology in the field of physiotherapy. In this regard, in order to prevent forgetfulness and doing wrong exercises in the application group, these exercises are provided to people through the application, which includes an instructional video of doing the exercises, teaching tips about back care, contacting the therapist, and sending a reminder message. Doing exercises and the message of doing or not doing exercises by the person is sent to the therapist through the application.</i_keyword>
      <i_keyword>Control group: The duration of interventions is 4 weeks with one month of follow-up. Patients are visited three times a week in the physiotherapy centers of the School of Rehabilitation and the interventions will be performed under the supervision of the project researchers. The duration of each exercise therapy session can vary depending on the stage of the treatment protocol and the number of exercises. Due to the difficulty of stabilizing exercises and the emphasis on doing the exercises correctly, patients in both groups are given a period of time to learn basic and basic exercises with the help of compression biofeedback, and then a 4-week treatment protocol with one month of follow-up. begins. In both groups, people first do some general stretching exercises to warm up before the main exercises; In the case of neurodynamic exercises, 4 exercises are considered that will be used only for patients with chronic low back pain who have pain referred to the lower extremities. Each neurodynamic exercise is performed one set of 20 per day. In the case of stabilization exercises, each exercise is held for 5 to 10 seconds and repeated 10 times a day (a set of ten). Each session adds one exercise to the patient's exercises so that in the first 4 weeks the patient receives all the relevant exercises and in the next 4 weeks repeats all the exercises; During this period, the number and timing of the exercises are improved. At the end of this section, the exercise schedule is set, but this schedule may change slightly depending on the patient's ability and skills. The patient is asked to do the exercises on a daily basis at home. In the control group, the exercises and tips for taking care of the back are provided through a tutorial booklet with explanations and it is recommended to him to set phone alarm in order to not forget doing home exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment. Method of measurement: Oswestry questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Low back  neuromuscular control. Timepoint: At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment. Method of measurement: Double leg lowering test.</sec_outcome>
      <sec_outcome>Neurodynamic. Timepoint: At the beginning of the study (before the intervention) and after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment. Method of measurement: Straight leg raise test.</sec_outcome>
      <sec_outcome>Patient satisfaction with treatment. Timepoint: after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment. Method of measurement: Special satisfaction questionnaire for this study.</sec_outcome>
      <sec_outcome>Adherence to home exercise program. Timepoint: after the end of treatment (one month later at the end of physiotherapy sessions), and two months after the start of treatment. Method of measurement: Exercise Adherence 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-03</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Department of Physiotherapy, School of Rehabilitation Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
