<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/NCT04423445</url>
  </required_header>
  <id_info>
    <org_study_id>ECKIRB1071102</org_study_id>
    <nct_id>NCT04423445</nct_id>
  </id_info>
  <brief_title>Laser Acupuncture and Acupressure for Low Back Pain</brief_title>
  <official_title>Laser Acupuncture Combined With Acupressure Improves Low Back Pain and Quality of Life: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>En Chu Kong Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>En Chu Kong Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem&#xD;
      that affects physiological functions and reduces work efficiency in nurses.&#xD;
&#xD;
      Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined&#xD;
      with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital&#xD;
      nurses with LBP.&#xD;
&#xD;
      Methods: This single-blinded randomized controlled trial enrolled a convenience sample of&#xD;
      nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA&#xD;
      group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks,&#xD;
      and a control group (n=38) receiving a similar intervention but without laser energy and&#xD;
      acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF)&#xD;
      and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the&#xD;
      intervention, and Week 2 and Week 4 during the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The enrollment criteria were age more than 20 years, low back pain with visual analogue scale&#xD;
      (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to&#xD;
      participate in this study. Exclusion criteria were open wounds on lower back, tumor on the&#xD;
      back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or&#xD;
      pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">May 22, 2019</completion_date>
  <primary_completion_date type="Actual">May 22, 2019</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>This single-blinded randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>pain intensity and interference</measure>
    <time_frame>Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.</time_frame>
    <description>Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>life dysfunction</measure>
    <time_frame>Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.</time_frame>
    <description>Secondary outcomes were aspects of life dysfunction as measured by the Roland Morris Disability Questionnaire (RMDQ), which measures disability in daily life due to LBP. This questionnaire consists of 24 items, each one a statement that the patient is asked to indicate whether this statement applies to him/her.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Laser acupuncture combined with acupressure (LAA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 4-week LAA intervention included low-level laser acupuncture and auricular acupressure. Six acupuncture points were selected, and three auricular points. Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. After five days, the seed was removed, and a new seed was taped on the other ear.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control participants received a similar intervention, but without laser energy output or acupressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laser acupuncture combined with acupressure</intervention_name>
    <description>Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. The de qi sensation appears to be an established intervention efficacy indicator during auricular acupressure. After five days, the seed was removed, and a new seed was taped on the other ear.</description>
    <arm_group_label>Laser acupuncture combined with acupressure (LAA)</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3&#xD;
&#xD;
          -  no regular treatment for low back pain within six weeks&#xD;
&#xD;
          -  willing to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  open wounds on lower back&#xD;
&#xD;
          -  tumor on the back&#xD;
&#xD;
          -  ankylosing spondylitis&#xD;
&#xD;
          -  previous lumbar surgery&#xD;
&#xD;
          -  coagulopathy or bleeding tendency&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsueh-Hua Yang, MASTER</last_name>
    <role>Principal Investigator</role>
    <affiliation>EN CHU HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>En Chu Kong Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>23702</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>En Chu Kong Hospital</investigator_affiliation>
    <investigator_full_name>Hsueh-Hua Yang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>acupressure</keyword>
  <keyword>low back pain</keyword>
  <keyword>low-level laser</keyword>
  <keyword>life dysfunction</keyword>
  <keyword>hospital nurses</keyword>
  <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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04423445/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04423445
org study id: ECKIRB1071102
nct id: NCT04423445
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem
      that affects physiological functions and reduces work efficiency in nurses.

      Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined
      with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital
      nurses with LBP.

      Methods: This single-blinded randomized controlled trial enrolled a convenience sample of
      nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA
      group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks,
      and a control group (n=38) receiving a similar intervention but without laser energy and
      acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF)
      and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the
      intervention, and Week 2 and Week 4 during the intervention.
The enrollment criteria were age more than 20 years, low back pain with visual analogue scale
      (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to
      participate in this study. Exclusion criteria were open wounds on lower back, tumor on the
      back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or
      pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
masking description: This single-blinded randomized controlled trial
measure: pain intensity and interference
time frame: Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.
description: Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).
measure: life dysfunction
time frame: Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.
description: Secondary outcomes were aspects of life dysfunction as measured by the Roland Morris Disability Questionnaire (RMDQ), which measures disability in daily life due to LBP. This questionnaire consists of 24 items, each one a statement that the patient is asked to indicate whether this statement applies to him/her.
arm group label: Laser acupuncture combined with acupressure (LAA)
arm group type: Experimental
description: A 4-week LAA intervention included low-level laser acupuncture and auricular acupressure. Six acupuncture points were selected, and three auricular points. Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. After five days, the seed was removed, and a new seed was taped on the other ear.
arm group label: Control group
arm group type: No Intervention
description: Control participants received a similar intervention, but without laser energy output or acupressure.
intervention type: Other
intervention name: Laser acupuncture combined with acupressure
description: Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. The de qi sensation appears to be an established intervention efficacy indicator during auricular acupressure. After five days, the seed was removed, and a new seed was taped on the other ear.
arm group label: Laser acupuncture combined with acupressure (LAA)
other name: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hsueh-Hua Yang, MASTER
role: Principal Investigator
affiliation: EN CHU HOSPITAL
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: En Chu Kong Hospital
investigator full name: Hsueh-Hua Yang
investigator title: Principal Investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
provided document: 