xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970419</url>
    </required_header>
    <id_info>
      <org_study_id>Tasnim Mohamed Elfeky</org_study_id>
      <nct_id>NCT05970419</nct_id>
    </id_info>
    <brief_title>Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain</brief_title>
    <official_title>Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will be conducted to answer the following question: Does high power laser&#xD;
        acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue&#xD;
        and level of satisfaction in chronic nonspecific low back pain patients?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aims of this study are:&#xD;
  &#xD;
          1. To investigate the effect of high power laser acupuncture on pain in chronic nonspecific&#xD;
             low back pain patients&#xD;
  &#xD;
          2. To investigate the effect of high power laser acupuncture on back range of motion&#xD;
             (flexion, extension, side bending and rotation) in chronic nonspecific low back pain&#xD;
             patients.&#xD;
  &#xD;
          3. To investigate the effect of high power laser acupuncture on function in chronic&#xD;
             nonspecific low back pain patients.&#xD;
  &#xD;
          4. To investigate the effect of high power laser acupuncture on quality of life in chronic&#xD;
             nonspecific low back pain patients.&#xD;
  &#xD;
          5. To investigate the effect of high power laser acupuncture on back muscle fatigue in&#xD;
             chronic nonspecific low back pain patients.&#xD;
  &#xD;
          6. To investigate the effect of high power laser acupuncture on level of satisfaction in&#xD;
             chronic nonspecific low back pain patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessing the change in intensity of pain</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>By using visual analoge scale (VAS). It is a valid and reliable measure to assess pain intensity level by patients by making a mark determining a decimal number from 0 to 100 (mm) on line with 'no pain' to the left and severe pain could be to the right. The subjects will rate their perception of pain by making a mark on the VAS line. The distance from the left to the mark will be measured and the accuracy will be adjusted to one decimal place.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the change in Back Range of Motion</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>By using the Back Range of Motion Instrument (BROM). It is a valid and reliable measure to assess back range of motion (flexion, extension, side bending and rotation) The BROM is uses a patented inclinometer based instrument for measuring lateral side bend in the preferred upright position. The magnetic inclinometer and reference eliminate hip substitution errors. The BROM Basic includes two Universal Inclinometers for measuring flexion and extension of the lumbar spine.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the change in Quality of Life</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>By using the short version of the WHO Quality of Life Instrument in Arabic. It will be used to assess quality of life.&#xD;
  The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domains scores are scaled in a positive direction higher score denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the change in endurance of the trunk extensor muscles</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>By using Biering-Sorensen test. The Sorensen test allows for a rapid, simple, and reproducible evaluation of the isometric endurance of the trunk extensor muscles. It discriminates between healthy individuals and patients with low back pain and may predict the occurrence of low back pain in the near future. The test consists in measuring the amount of time a person can hold the unsupported upper body in a horizontal prone position with the lower body fixed to the examining table.&#xD;
  The Biering-Sørensen test for measuring back muscle fatigue is valid and provides reliable measures of position-holding time and can discriminate between subjects with and without nonspecific low back pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the change in patient satisfaction</measure>
      <time_frame>at baseline and after 4 weeks of intervention</time_frame>
      <description>By using The MedRisk Instrument for Measuring Patient Satisfaction (MRPS). A Self-report measures that sample a variety of items provide clinicians with an array of information that may assist in assessing patient satisfaction. The MRPS questionnaire is valid and reliable for measuring patient satisfaction. It has a 2-factor structure: &quot;internal,&quot; relating to the patient-therapist interaction, and &quot;external,&quot; describing no therapist issues such as admissions and clinic environment.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>High power laser acupuncture group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive high power laser acupuncture (HPLA) +conventional therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional treatment group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>high power laser acupuncture (HPLA)</intervention_name>
      <description>HPLA will be provided in Wave length 1064 (nm) Energy Density (0.510-0.1780 J/cm 2) Power Average (3000 W) pulsed Time per Point (14s) for acupoints. Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t</description>
      <arm_group_label>High power laser acupuncture group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>conventional treatment</intervention_name>
      <description>Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE).&#xD;
  General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.</description>
      <arm_group_label>Conventional treatment group</arm_group_label>
      <arm_group_label>High power laser acupuncture group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sham laser</intervention_name>
      <description>sham laser (Not active)</description>
      <arm_group_label>Conventional treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects will be included in this study will be having all of the following criteria:&#xD;
  &#xD;
            1. Age over 18 years of age.&#xD;
  &#xD;
            2. Both genders (males and females).&#xD;
  &#xD;
            3. Normal BMI ranges between 18.5:24.9 kg/m2.&#xD;
  &#xD;
            4. Patients will be referred from an orthopedist with diagnosis of chronic low back pain&#xD;
               without underlying pathological causes. The patients with chronic nonspecific low back&#xD;
               pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale&#xD;
               (VAS) for pain, which ranges from 0 to 100 mm.&#xD;
  &#xD;
          6) CNSLBP patients will be diagnosed based on the standard criteria, including pain and&#xD;
          tenderness on lower back and a negative result for all special tests for lumber&#xD;
          neurological examination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of any surgical procedure in the back or the lower extremities.&#xD;
  &#xD;
            2. Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis,&#xD;
               fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or&#xD;
               cauda equine syndrome).&#xD;
  &#xD;
            3. Patient with lumbar instability including spondylolisthesis.&#xD;
  &#xD;
            4. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to&#xD;
               lower limb, bowel and bladder dysfunction).&#xD;
  &#xD;
            5. Pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tasnim Mohamed</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tasnim Mohamed</last_name>
      <phone>+20 106 800 3447</phone>
      <email>eth.com@pt.cu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Outpatient clinic faculty of physical therapy cairo university</name>
        <address>
          <city>Dokki</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Tasnim Mohamed Elfeky</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970419
  org study id: Tasnim Mohamed Elfeky
  nct id: NCT05970419
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study will be conducted to answer the following question: Does high power laser
        acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue
        and level of satisfaction in chronic nonspecific low back pain patients?
  The aims of this study are:
  
          1. To investigate the effect of high power laser acupuncture on pain in chronic nonspecific
             low back pain patients
  
          2. To investigate the effect of high power laser acupuncture on back range of motion
             (flexion, extension, side bending and rotation) in chronic nonspecific low back pain
             patients.
  
          3. To investigate the effect of high power laser acupuncture on function in chronic
             nonspecific low back pain patients.
  
          4. To investigate the effect of high power laser acupuncture on quality of life in chronic
             nonspecific low back pain patients.
  
          5. To investigate the effect of high power laser acupuncture on back muscle fatigue in
             chronic nonspecific low back pain patients.
  
          6. To investigate the effect of high power laser acupuncture on level of satisfaction in
             chronic nonspecific low back pain patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Assessing the change in intensity of pain
  time frame: at baseline and after 4 weeks of intervention
  description: By using visual analoge scale (VAS). It is a valid and reliable measure to assess pain intensity level by patients by making a mark determining a decimal number from 0 to 100 (mm) on line with 'no pain' to the left and severe pain could be to the right. The subjects will rate their perception of pain by making a mark on the VAS line. The distance from the left to the mark will be measured and the accuracy will be adjusted to one decimal place.
  measure: Assessing the change in Back Range of Motion
  time frame: at baseline and after 4 weeks of intervention
  description: By using the Back Range of Motion Instrument (BROM). It is a valid and reliable measure to assess back range of motion (flexion, extension, side bending and rotation) The BROM is uses a patented inclinometer based instrument for measuring lateral side bend in the preferred upright position. The magnetic inclinometer and reference eliminate hip substitution errors. The BROM Basic includes two Universal Inclinometers for measuring flexion and extension of the lumbar spine.
  measure: Assessing the change in Quality of Life
  time frame: at baseline and after 4 weeks of intervention
  description: By using the short version of the WHO Quality of Life Instrument in Arabic. It will be used to assess quality of life.
  The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domains scores are scaled in a positive direction higher score denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
  measure: Assessing the change in endurance of the trunk extensor muscles
  time frame: at baseline and after 4 weeks of intervention
  description: By using Biering-Sorensen test. The Sorensen test allows for a rapid, simple, and reproducible evaluation of the isometric endurance of the trunk extensor muscles. It discriminates between healthy individuals and patients with low back pain and may predict the occurrence of low back pain in the near future. The test consists in measuring the amount of time a person can hold the unsupported upper body in a horizontal prone position with the lower body fixed to the examining table.
  The Biering-Sørensen test for measuring back muscle fatigue is valid and provides reliable measures of position-holding time and can discriminate between subjects with and without nonspecific low back pain.
  measure: Assessing the change in patient satisfaction
  time frame: at baseline and after 4 weeks of intervention
  description: By using The MedRisk Instrument for Measuring Patient Satisfaction (MRPS). A Self-report measures that sample a variety of items provide clinicians with an array of information that may assist in assessing patient satisfaction. The MRPS questionnaire is valid and reliable for measuring patient satisfaction. It has a 2-factor structure: "internal," relating to the patient-therapist interaction, and "external," describing no therapist issues such as admissions and clinic environment.
  arm group label: High power laser acupuncture group
  arm group type: Experimental
  description: This group will receive high power laser acupuncture (HPLA) +conventional therapy
  arm group label: Conventional treatment group
  arm group type: Active Comparator
  description: This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.
  intervention type: Other
  intervention name: high power laser acupuncture (HPLA)
  description: HPLA will be provided in Wave length 1064 (nm) Energy Density (0.510-0.1780 J/cm 2) Power Average (3000 W) pulsed Time per Point (14s) for acupoints. Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t
  arm group label: High power laser acupuncture group
  intervention type: Other
  intervention name: conventional treatment
  description: Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE).
  General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.
  arm group label: Conventional treatment group
  arm group label: High power laser acupuncture group
  intervention type: Other
  intervention name: Sham laser
  description: sham laser (Not active)
  arm group label: Conventional treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tasnim Mohamed
  role: Principal Investigator
  affiliation: Cairo University
  last name: Tasnim Mohamed
  phone: +20 106 800 3447
  email: eth.com@pt.cu.edu.eg
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Tasnim Mohamed Elfeky
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: Undecided