<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/NCT04424823</url>
  </required_header>
  <id_info>
    <org_study_id>108-088-F</org_study_id>
    <nct_id>NCT04424823</nct_id>
  </id_info>
  <brief_title>LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses</brief_title>
  <official_title>Light -Emitting Diode Photobiomodulation Therapy for Non-specific Low Back Pain in Working Nurses: A Single-center, Double-blind, Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital Hsin-Chu Branch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital Hsin-Chu Branch</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>
      Background: Low back pain (LBP) affects approximately 51-57% of hospital nurses and nurses'&#xD;
      aides in Europe. New high-risk groups include home- and long-term-care nurses and&#xD;
      physiotherapists. A number of European countries are experiencing a shortage of healthcare&#xD;
      workers. Light therapy has been shown to be an effective treatment for various&#xD;
      musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain,&#xD;
      carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and&#xD;
      meta-analysis demonstrated that low-level laser therapy is an effective method for relieving&#xD;
      non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode&#xD;
      (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy&#xD;
      on NSCLBP.&#xD;
&#xD;
      Methods and analysis: The investigators conducted a prospective, double-blind, randomized&#xD;
      placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to&#xD;
      two groups: intervention group, where patients received LED photobiomodulation therapy three&#xD;
      times a week for 2 weeks, and the control group, where patients had sham treatment only three&#xD;
      times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain,&#xD;
      lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures&#xD;
      included a Multidimensional Fatigue Inventory, Fear-Avoidance Beliefs Questionnaire, and the&#xD;
      Oswestry Disability Index. The outcome measures were assessed before therapy and 2 weeks, 4&#xD;
      weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.&#xD;
&#xD;
      Discussion: This study is a prospective, single-center, double-blind, randomized, controlled&#xD;
      study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working&#xD;
      nurse. The results will be useful for patients, working nurses, nurses' aides, and other&#xD;
      healthcare workers with chronic low back pain.&#xD;
&#xD;
      Trial registration number: This protocol was registered in ClinicalTrials.gov, under the&#xD;
      number 108-088-F.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 18, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 18, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measure assessing change of Lumbar active range of motion between baseline to every time points</measure>
    <time_frame>baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months</time_frame>
    <description>Including forward flexion, extension, and right and left rotations and were measured in degrees using a back range of motion instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measure assessing change of 100-mm visual analog scale (VAS) between baseline to every time points</measure>
    <time_frame>2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months</time_frame>
    <description>A 100-mm visual analog scale (VAS), which was used for low back pain assessment. The anchor terms of the VAS were 0 (no pain) and 10 (maximum pain imaginable). Higher VAS scores indicate greater pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measure assessing change of Chair-rising time between baseline to every time points</measure>
    <time_frame>2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months</time_frame>
    <description>Chair-rising time, wherein the time required for participants to rise five times from a seated position in a standard chair to a standing position as quickly as possible, without using their arms for support, was measured. A longer chair-rising time represents greater physical function limitations.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">148</enrollment>
  <condition>Conditions for Lower Back Pain Working Nurse</condition>
  <arm_group>
    <arm_group_label>LED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LED photobiomodulation therapy for the non-specific LBP working nurse</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Shame group. The all procedure was same as the LED group but the LED ped was upside down without direct treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LED photobiomodulation</intervention_name>
    <description>Patients were submitted to photobiomodulation therapy with wavelengths of both 630-nm and 850-nm for RED and near-infrared LEDs, with power density set to 8.5 mW/cm2 and 12.5 mW/cm2, respectively. The LED device (name of device, Applied BioPhotonics) was designed in Silicon Valley, United States, and was approved by the United States Food and Drug Administration for the treatment of minor muscle and joint pain. LED therapy was applied by placing the device on the skin at a 90° angle. Both groups underwent six times therapy sessions (i.e., three times a week for 2 weeks), and during the therapy, only the researcher in charge of programming the LED device was aware of the treatment employed; the programmer did not participate in the execution of the treatments, evaluations, or data analysis.</description>
    <arm_group_label>LED</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female registered nurses aged 18-65 years with non-specific chronic LBP, which&#xD;
             is defined as pain or discomfort between the costal margins and inferior gluteal folds&#xD;
             with or without referred pain to the lower limbs, and persistent LBP for at least 3&#xD;
             months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis,&#xD;
             severe psoriasis, and severe hives lupus)&#xD;
&#xD;
          -  LBP associated with nerve root compromise (measured by clinical examination of&#xD;
             dermatomes, myotomes, and reflexes)&#xD;
&#xD;
          -  serious spinal pathologies, such as fractures, tumors, and inflammatory and infectious&#xD;
             diseases&#xD;
&#xD;
          -  decompensated heart disease or metabolic disorders&#xD;
&#xD;
          -  previous spinal surgery&#xD;
&#xD;
          -  pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital Hsin-Chu Branch</investigator_affiliation>
    <investigator_full_name>Wei-Tso Chia MD PhD</investigator_full_name>
    <investigator_title>Assistant Professor, Deputy Director of Orthopaedics Department</investigator_title>
  </responsible_party>
  <keyword>LED</keyword>
  <keyword>LBP</keyword>
  <keyword>photobiomodulation</keyword>
  <keyword>nurse</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>
  <!-- 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/NCT04424823
org study id: 108-088-F
nct id: NCT04424823
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Low back pain (LBP) affects approximately 51-57% of hospital nurses and nurses'
      aides in Europe. New high-risk groups include home- and long-term-care nurses and
      physiotherapists. A number of European countries are experiencing a shortage of healthcare
      workers. Light therapy has been shown to be an effective treatment for various
      musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain,
      carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and
      meta-analysis demonstrated that low-level laser therapy is an effective method for relieving
      non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode
      (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy
      on NSCLBP.

      Methods and analysis: The investigators conducted a prospective, double-blind, randomized
      placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to
      two groups: intervention group, where patients received LED photobiomodulation therapy three
      times a week for 2 weeks, and the control group, where patients had sham treatment only three
      times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain,
      lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures
      included a Multidimensional Fatigue Inventory, Fear-Avoidance Beliefs Questionnaire, and the
      Oswestry Disability Index. The outcome measures were assessed before therapy and 2 weeks, 4
      weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.

      Discussion: This study is a prospective, single-center, double-blind, randomized, controlled
      study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working
      nurse. The results will be useful for patients, working nurses, nurses' aides, and other
      healthcare workers with chronic low back pain.

      Trial registration number: This protocol was registered in ClinicalTrials.gov, under the
      number 108-088-F.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: measure assessing change of Lumbar active range of motion between baseline to every time points
time frame: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
description: Including forward flexion, extension, and right and left rotations and were measured in degrees using a back range of motion instrument.
measure: measure assessing change of 100-mm visual analog scale (VAS) between baseline to every time points
time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
description: A 100-mm visual analog scale (VAS), which was used for low back pain assessment. The anchor terms of the VAS were 0 (no pain) and 10 (maximum pain imaginable). Higher VAS scores indicate greater pain intensity.
measure: measure assessing change of Chair-rising time between baseline to every time points
time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
description: Chair-rising time, wherein the time required for participants to rise five times from a seated position in a standard chair to a standing position as quickly as possible, without using their arms for support, was measured. A longer chair-rising time represents greater physical function limitations.
arm group label: LED
arm group type: Experimental
description: LED photobiomodulation therapy for the non-specific LBP working nurse
arm group label: Sham
arm group type: Sham Comparator
description: Shame group. The all procedure was same as the LED group but the LED ped was upside down without direct treatment.
intervention type: Procedure
intervention name: LED photobiomodulation
description: Patients were submitted to photobiomodulation therapy with wavelengths of both 630-nm and 850-nm for RED and near-infrared LEDs, with power density set to 8.5 mW/cm2 and 12.5 mW/cm2, respectively. The LED device (name of device, Applied BioPhotonics) was designed in Silicon Valley, United States, and was approved by the United States Food and Drug Administration for the treatment of minor muscle and joint pain. LED therapy was applied by placing the device on the skin at a 90° angle. Both groups underwent six times therapy sessions (i.e., three times a week for 2 weeks), and during the therapy, only the researcher in charge of programming the LED device was aware of the treatment employed; the programmer did not participate in the execution of the treatments, evaluations, or data analysis.
arm group label: LED
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital Hsin-Chu Branch
investigator full name: Wei-Tso Chia MD PhD
investigator title: Assistant Professor, Deputy Director of Orthopaedics Department
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No