<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/NCT03822273</url>
  </required_header>
  <id_info>
    <org_study_id>201701455A3</org_study_id>
    <nct_id>NCT03822273</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Acupuncture for Patients With Rib Fractures</brief_title>
  <official_title>Analgesic Effect of Acupuncture for Patients With Rib Fractures: a Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Traumatic rib fractures are common, resulting from significant forces impacting on the chest,&#xD;
      and are associated with significant morbidity and mortality. Acute pain management in&#xD;
      inpatients with traumatic rib fractures has been highly emphasized by practitioners.&#xD;
      Inappropriate analgesia may cause respiratory complications, including pneumonia,&#xD;
      atelectasis, acute respiratory distress syndrome, and prolonged hospital stay. These may be&#xD;
      prevented or reduced by good analgesic therapy. This study is aimed to investigate the&#xD;
      analgesic effect of acupuncture on traumatic rib fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This open-label, randomized controlled trial will involve 150 patients who have traumatic rib&#xD;
      fractures. Subjects are randomly assigned to acupuncture group, laser acupuncture group or&#xD;
      sham laser acupuncture group with a 1:1:1 ratio. The intervention will be performed on the&#xD;
      consecutive three day after allocation. Bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli)&#xD;
      and GB34 (Yanglingquan) are used for each group. The traditional acupuncture group will be&#xD;
      performed by inserting needles to a depth of 15-35 mm and last for 15 min. The laser&#xD;
      acupuncture will be performed with the gallium aluminum arsenide LaserPen, which delivered&#xD;
      0.375 J of energy at each of the acupoints. Subjects in the control group underwent sham&#xD;
      laser acupuncture treatment without any laser output. The acupuncture points, application&#xD;
      duration, and total number of treatments were similar to those in the laser acupuncture&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>
    <intervention_model_description>Acupuncture group&#xD;
Laser acupuncture group&#xD;
Sham laser acupuncture group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All the patients are told that they will receive one kind of acupuncture treatment in addition to the original oral analgesics and assess the efficacy of acupuncture. The patients are randomly assigned to three groups after providing written informed consent, without being mentioned which kind of acupuncture treatment is applied as control. Patients are not blinded to TA or LA treatment, but they can be blinded to LA or SLA treatment. The outcome assessor is also blinded to the group assignments and is trained to apply the pain scales and conduct physical tests. To avoid unblinding of the assessment of outcomes, the patients are instructed not to discuss any aspect related to their treatment with the assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of pain relief</measure>
    <time_frame>The NRS will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. Primary outcome is the change of NRS score on DAY 1 pretreatment and DAY 3 post treatment.</time_frame>
    <description>Maximal pain intensity (Numerical Rating Scale; NRS: 0-10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained maximal inspiration lung volumes</measure>
    <time_frame>The sustained maximal inspiration lung volumes will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.</time_frame>
    <description>Sustained maximal inspiration lung volumes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases with pulmonary complications</measure>
    <time_frame>Follow-up for one month</time_frame>
    <description>Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva cortisol level</measure>
    <time_frame>The saliva cortisol level will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.</time_frame>
    <description>Saliva cortisol level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variation</measure>
    <time_frame>The heart rate variation will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.</time_frame>
    <description>Heart rate variation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The dose of narcotic and non-narcotic analgesics used</measure>
    <time_frame>Record the medication use for 2 weeks after participant enrolled</time_frame>
    <description>Record the use of narcotic and non narcotic analgesics based on chart reviews. Narcotic drugs include codeine, tramadol, and morphine. Non narcotic drugs include acetaminophen, ibuprofen, diclofenac, ketoprofen, mefenamic acid, and parecoxib.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Rib Fractures</condition>
  <condition>Acute Pain</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Traditional acupuncture (TA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subject will receive real acupuncture treatment once per day for 3 days after enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser acupuncture (LA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham laser acupuncture (SLA)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional acupuncture (TA)</intervention_name>
    <description>Procedure: real acupuncture.&#xD;
Eight disposable, single use, sterilized, stainless steel needles are inserted at each session, and the bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for acupuncture treatment. The acupuncture needles are to be inserted to a depth of 15-35 mm. All needles are rotated manually at least once at each session to elicit needle sensation (De qi). The needle retention time is 15 min.</description>
    <arm_group_label>Traditional acupuncture (TA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser acupuncture (LA)</intervention_name>
    <description>Procedure: laser acupuncture.&#xD;
Participants allocated to the LA group receive laser acupuncture treatment at the same acupoints used in acupuncture group. The laser acupuncture therapy will be performed with the gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz]; RJ-Laser, Reimers &amp; Janssen GmbH, Waldkirch, Germany). The laser will be applied to each point for 5 seconds, which delivered 0.375 J of energy at each of the acupoints: LI4 (Hegu, B3), SJ6 (Zhigou, B3), ST36 (Zusanli, B2) and GB34 (Yanglingquan, B2).</description>
    <arm_group_label>Laser acupuncture (LA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham laser acupuncture (SLA)</intervention_name>
    <description>Procedure: sham laser acupuncture.&#xD;
Subjects in the control group receive sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the LA group.</description>
    <arm_group_label>Sham laser acupuncture (SLA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Chest trauma&#xD;
&#xD;
          -  Presence of one or more, unilateral or bilateral rib fractures diagnosed with chest&#xD;
             X-ray&#xD;
&#xD;
          -  Maximal rib pain score of more than 5 obtained using the numerical rating scale (NRS:&#xD;
             0-10)&#xD;
&#xD;
          -  Ability to describe the sites of pain and evaluate the pain intensity accurately&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to describe the sites of pain and evaluate the pain intensity accurately&#xD;
&#xD;
          -  There are open wounds on the sites of acupuncture points&#xD;
&#xD;
          -  Severe multiple trauma or any poorly controlled diseases such as atelectasis,&#xD;
             pneumonia, or other infectious diseases, immune system dysfunction, bleeding tendency,&#xD;
             psychiatric disorders, and skin problems&#xD;
&#xD;
          -  Receive surgical management of rib fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chun-Ting Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chun-Ting Liu</investigator_full_name>
    <investigator_title>Attending doctor</investigator_title>
  </responsible_party>
  <keyword>Traumatic rib fractures</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Rib Fractures</mesh_term>
  </condition_browse>
  <!-- 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/NCT03822273
org study id: 201701455A3
nct id: NCT03822273
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traumatic rib fractures are common, resulting from significant forces impacting on the chest,
      and are associated with significant morbidity and mortality. Acute pain management in
      inpatients with traumatic rib fractures has been highly emphasized by practitioners.
      Inappropriate analgesia may cause respiratory complications, including pneumonia,
      atelectasis, acute respiratory distress syndrome, and prolonged hospital stay. These may be
      prevented or reduced by good analgesic therapy. This study is aimed to investigate the
      analgesic effect of acupuncture on traumatic rib fractures.
This open-label, randomized controlled trial will involve 150 patients who have traumatic rib
      fractures. Subjects are randomly assigned to acupuncture group, laser acupuncture group or
      sham laser acupuncture group with a 1:1:1 ratio. The intervention will be performed on the
      consecutive three day after allocation. Bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli)
      and GB34 (Yanglingquan) are used for each group. The traditional acupuncture group will be
      performed by inserting needles to a depth of 15-35 mm and last for 15 min. The laser
      acupuncture will be performed with the gallium aluminum arsenide LaserPen, which delivered
      0.375 J of energy at each of the acupoints. Subjects in the control group underwent sham
      laser acupuncture treatment without any laser output. The acupuncture points, application
      duration, and total number of treatments were similar to those in the laser acupuncture
      group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Acupuncture group
Laser acupuncture group
Sham laser acupuncture group
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All the patients are told that they will receive one kind of acupuncture treatment in addition to the original oral analgesics and assess the efficacy of acupuncture. The patients are randomly assigned to three groups after providing written informed consent, without being mentioned which kind of acupuncture treatment is applied as control. Patients are not blinded to TA or LA treatment, but they can be blinded to LA or SLA treatment. The outcome assessor is also blinded to the group assignments and is trained to apply the pain scales and conduct physical tests. To avoid unblinding of the assessment of outcomes, the patients are instructed not to discuss any aspect related to their treatment with the assessor.
measure: Efficacy of pain relief
time frame: The NRS will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. Primary outcome is the change of NRS score on DAY 1 pretreatment and DAY 3 post treatment.
description: Maximal pain intensity (Numerical Rating Scale; NRS: 0-10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed.
measure: Sustained maximal inspiration lung volumes
time frame: The sustained maximal inspiration lung volumes will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.
description: Sustained maximal inspiration lung volumes
measure: Number of cases with pulmonary complications
time frame: Follow-up for one month
description: Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.
measure: Saliva cortisol level
time frame: The saliva cortisol level will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.
description: Saliva cortisol level
measure: Heart rate variation
time frame: The heart rate variation will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.
description: Heart rate variation
measure: The dose of narcotic and non-narcotic analgesics used
time frame: Record the medication use for 2 weeks after participant enrolled
description: Record the use of narcotic and non narcotic analgesics based on chart reviews. Narcotic drugs include codeine, tramadol, and morphine. Non narcotic drugs include acetaminophen, ibuprofen, diclofenac, ketoprofen, mefenamic acid, and parecoxib.
arm group label: Traditional acupuncture (TA)
arm group type: Experimental
description: The subject will receive real acupuncture treatment once per day for 3 days after enrollment.
arm group label: Laser acupuncture (LA)
arm group type: Active Comparator
description: The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.
arm group label: Sham laser acupuncture (SLA)
arm group type: Placebo Comparator
description: The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.
intervention type: Procedure
intervention name: Traditional acupuncture (TA)
description: Procedure: real acupuncture.
Eight disposable, single use, sterilized, stainless steel needles are inserted at each session, and the bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for acupuncture treatment. The acupuncture needles are to be inserted to a depth of 15-35 mm. All needles are rotated manually at least once at each session to elicit needle sensation (De qi). The needle retention time is 15 min.
arm group label: Traditional acupuncture (TA)
intervention type: Procedure
intervention name: Laser acupuncture (LA)
description: Procedure: laser acupuncture.
Participants allocated to the LA group receive laser acupuncture treatment at the same acupoints used in acupuncture group. The laser acupuncture therapy will be performed with the gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz]; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser will be applied to each point for 5 seconds, which delivered 0.375 J of energy at each of the acupoints: LI4 (Hegu, B3), SJ6 (Zhigou, B3), ST36 (Zusanli, B2) and GB34 (Yanglingquan, B2).
arm group label: Laser acupuncture (LA)
intervention type: Procedure
intervention name: Sham laser acupuncture (SLA)
description: Procedure: sham laser acupuncture.
Subjects in the control group receive sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the LA group.
arm group label: Sham laser acupuncture (SLA)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
last name: Chun-Ting Liu, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chun-Ting Liu
investigator title: Attending doctor
mesh term: Acute Pain
mesh term: Fractures, Bone
mesh term: Rib Fractures