<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/NCT02260284</url>
  </required_header>
  <id_info>
    <org_study_id>2014LBP01</org_study_id>
    <nct_id>NCT02260284</nct_id>
  </id_info>
  <brief_title>The Effect of Acupuncture in Treating Chronic Low-back Pain</brief_title>
  <official_title>The Effect of Acupuncture in Treating Chronic Low-back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic&#xD;
      low-back pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We want to know if the Yaotong points penetration or standardized acupuncture mode are more&#xD;
      effective than medical care alone for CLBP; and if Yaotong points penetration is more&#xD;
      effective than standardized acupuncture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">October 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks</time_frame>
    <description>This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks</time_frame>
    <description>It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline on short-form 36 health survey (SF-36)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks</time_frame>
    <description>Physical and mental health component summary scores of the medical outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline on Visual Analog Scale at 24 weeks</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks</time_frame>
    <description>This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from &quot;no painat all&quot; to &quot;pain as bad as it could be.&quot; This scale has been found to be an excellent measure of self-reported pain</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Yaotong points acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients under the treatment of Yaotong ponts penetration mode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standardized acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients under the treatment of standardized acupuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yaotong points acupuncture</intervention_name>
    <description>Patients receive the treatments of Yaotong points penetration</description>
    <arm_group_label>Yaotong points acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the usual care</intervention_name>
    <description>participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))</description>
    <arm_group_label>the usual care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standardized acupuncture</intervention_name>
    <description>Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.</description>
    <arm_group_label>standardized acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with CLBP&#xD;
&#xD;
          -  without taking any other medication for the treatment of CLBP in at least 2 last&#xD;
             weeks;&#xD;
&#xD;
          -  aged from 18 to 50 years;&#xD;
&#xD;
          -  without conflict to the written, informed consent signed prior to the enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis&#xD;
             and infections);&#xD;
&#xD;
          -  complicated back problems (such as scoliologic &gt;40° curvature, chronic spondylitis,&#xD;
             sciatica, prior back surgery and other medicolegal issues);&#xD;
&#xD;
          -  with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation&#xD;
             disfunctions, being in pregnancy, seizure disorder);&#xD;
&#xD;
          -  conditions making treatment difficult (e.g., paralysis, psychoses);&#xD;
&#xD;
          -  conditions that might confound treatment effects or interpretation of results (e.g.,&#xD;
             severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);&#xD;
&#xD;
          -  previous acupuncture treatment for any condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital of Chengdu Military Area Command PLA</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Yang Min</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT02260284
org study id: 2014LBP01
nct id: NCT02260284
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic
      low-back pain
We want to know if the Yaotong points penetration or standardized acupuncture mode are more
      effective than medical care alone for CLBP; and if Yaotong points penetration is more
      effective than standardized acupuncture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
time frame: at 0 week, 12 weeks, 24 weeks
description: This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
measure: Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
time frame: at 0 week, 12 weeks, 24 weeks
description: It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.
measure: Changes from baseline on short-form 36 health survey (SF-36)
time frame: at 0 week, 12 weeks, 24 weeks
description: Physical and mental health component summary scores of the medical outcomes
measure: Changes from baseline on Visual Analog Scale at 24 weeks
time frame: at 0 week, 12 weeks, 24 weeks
description: This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no painat all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain
arm group label: Yaotong points acupuncture
arm group type: Experimental
description: patients under the treatment of Yaotong ponts penetration mode
arm group label: standardized acupuncture
arm group type: Active Comparator
description: patients under the treatment of standardized acupuncture
arm group label: the usual care
arm group type: Other
description: In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)).
intervention type: Other
intervention name: Yaotong points acupuncture
description: Patients receive the treatments of Yaotong points penetration
arm group label: Yaotong points acupuncture
intervention type: Other
intervention name: the usual care
description: participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))
arm group label: the usual care
intervention type: Other
intervention name: standardized acupuncture
description: Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.
arm group label: standardized acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chengdu PLA General Hospital
investigator full name: Yang Min
investigator title: Ph.D
mesh term: Spondylitis
mesh term: Spondylitis, Ankylosing
mesh term: Back Pain
mesh term: Low Back Pain