<?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>IRCT20250508065647N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-22</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of exercise and laser therapy on the muscle function and pain in People with low back pain from muscle weakness</public_title>
      <acronym></acronym>
      <scientific_title>The effects of dynamic neuromuscular stability (DNS) and low-level laser therapy on the muscle function and pain in People with low back pain from muscle weakness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83666</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Pairing of participants: First, a VAS pre-test will be administered to all(with chronic non-specific low back pain, without discopathy) and based on the participants' pre-test scores, they will be divided into pairs with similar pain intensity scores between 3 and 6 on the visual analogue scale.
Random assignment: Each pair will be randomly assigned to one of 4 groups: exercise and low-level laser, exercise group, laser group, and control group(10 people in each group. The intervention (exercise and low-level laser) will not be applied to the control group. Finally, a post-test will be administered and the data will be analyzed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:  Exercise; Ten female subjects will perform dynamic neuromuscular stability (DNS) exercises with myofascial release for 8 weeks, 3 sessions per week, each session lasting 90 minutes, as follows: First, 25 minutes of myofascial release exercises and 15 minutes of stretching exercises, then 40 minutes of DNS exercises with breathing exercises, and finally 10 minutes of cool-down exercises. Intervention 2: Intervention group 2: Low-level laser; Ten female subjects will undergo low-level laser on specific days and for a specific number of sessions. Also, the following model power meter will be used to measure the optical power of the device every two weeks (by a researcher who is not involved) and the type of laser device PHOTONCARE model Moonlight and Starlight (2020) made in Germany. Intervention 3: Intervention group 3:  Exercise and  low-level laser; Ten female subjects will perform dynamic neuromuscular stability (DNS) exercises with myofascial release for 8 weeks, 3 sessions per week, each session lasting 90 minutes, as follows: First, 25 minutes of myofascial release exercises and 15 minutes of stretching exercises, then 40 minutes of DNS exercises with breathing exercises, and finally 10 minutes of cool-down exercises and also subjects will undergo low-level laser on specific days and for a specific number of sessions. Also, the following model power meter will be used to measure the optical power of the device every two weeks (by a researcher who is not involved) and the type of laser device PHOTONCARE model Moonlight and Starlight (2020) made in Germany. Intervention 4: Control group 4: No intervention; Ten female subjects will be given control without Exercise and without low-level laser.</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 After finishing the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Rafieeamjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>U 2,  No. 8, Aseman De, Roshan Aly, Moshtagh Aval Ave, Bozorgmehr Sq, Isfahan, 8153687813</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8153687813</zip>
        <telephone>+98 31 3267 1146</telephone>
        <email>atefe.rafieeamjad@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Rafieeamjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>U 2,  No. 8, Aseman De, Roshan Aly, Moshtagh Aval Ave, Bozorgmehr Sq, Isfahan, 8153687813</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8153687813</zip>
        <telephone>+98 31 3267 1146</telephone>
        <email>atefe.rafieeamjad@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female gender
Non-Specific low back pain from muscle weakness
Confirmation of the type of low back pain with clinical examination and paraclinical evidence
Duration of low back pain more than three months
Age range 40 to 50 years
Pain intensity between 3 and 6 on the visual pain scale</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Aggravation of pain and disability with exercise
Trauma or surgery during exercise
Participation in regular weekly exercise activity
Medical prohibition against participation in exercise activity
Use of anti-inflammatory and analgesic medications</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>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:  Exercise; Ten female subjects will perform dynamic neuromuscular stability (DNS) exercises with myofascial release for 8 weeks, 3 sessions per week, each session lasting 90 minutes, as follows: First, 25 minutes of myofascial release exercises and 15 minutes of stretching exercises, then 40 minutes of DNS exercises with breathing exercises, and finally 10 minutes of cool-down exercises.</i_keyword>
      <i_keyword>Intervention group 2: Low-level laser; Ten female subjects will undergo low-level laser on specific days and for a specific number of sessions. Also, the following model power meter will be used to measure the optical power of the device every two weeks (by a researcher who is not involved) and the type of laser device PHOTONCARE model Moonlight and Starlight (2020) made in Germany</i_keyword>
      <i_keyword>Intervention group 3:  Exercise and  low-level laser; Ten female subjects will perform dynamic neuromuscular stability (DNS) exercises with myofascial release for 8 weeks, 3 sessions per week, each session lasting 90 minutes, as follows: First, 25 minutes of myofascial release exercises and 15 minutes of stretching exercises, then 40 minutes of DNS exercises with breathing exercises, and finally 10 minutes of cool-down exercises and also subjects will undergo low-level laser on specific days and for a specific number of sessions. Also, the following model power meter will be used to measure the optical power of the device every two weeks (by a researcher who is not involved) and the type of laser device PHOTONCARE model Moonlight and Starlight (2020) made in Germany</i_keyword>
      <i_keyword>Control group 4: No intervention; Ten female subjects will be given control without Exercise and without low-level laser</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring muscle pain intensity using a visual analog scale.</prim_outcome>
      <prim_outcome>Endurance of trunk flexor muscles. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring trunk flexor muscle endurance with modified sit-up tes.</prim_outcome>
      <prim_outcome>Endurance of trunk extensor muscles. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring the endurance of the trunk extensor muscles using the trunk lift test (extensor endurance).</prim_outcome>
      <prim_outcome>Strength of trunk flexor muscles. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring the strength of trunk flexor muscles with a dynamometer.</prim_outcome>
      <prim_outcome>Strength of trunk extensor muscles. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring the strength of trunk extensor muscles with a dynamometer.</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring the flexibility of the back and hamstring muscles with the Sit and Reach test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring quality of life with the SF36 quality of life questionnaire.</sec_outcome>
      <sec_outcome>Depression Inventory. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring depression Inventory using the modified version of the Beck Depression Inventory.</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring functional disability with Oswestry Disability Index.</sec_outcome>
      <sec_outcome>Range of motion of the lumbar spine. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Measuring the range of motion of the lumbar spine with the modified-modified schober test.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-15</approval_date>
        <contact_name>Ethics committee on Research Islamic Azad University - Marvdasht Branch</contact_name>
        <contact_address>Marvdasht: Three kilometers of Persepolis Boulevard. Islamic Azad University of Marvdasht Marvdasht Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
