<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/NCT03816787</url>
  </required_header>
  <id_info>
    <org_study_id>NIRS for Cupping Therapy</org_study_id>
    <nct_id>NCT03816787</nct_id>
  </id_info>
  <brief_title>Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain</brief_title>
  <official_title>Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
      This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on&#xD;
      low back pain. 50 patients with low back pain as experimental group and 50 healthy people as&#xD;
      control group are treated by DCT. They will receive four consecutive WCT application in one&#xD;
      month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin&#xD;
      ([HbO2]), deoxy-hemoglobin ([Hb]) and the derived change in blood volume ([tHb]) in/surround&#xD;
      the cupping sites during treatment. The investigators hope to interpret the curative effect&#xD;
      of DCT from the perspective of modern hemodynamics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2019</start_date>
  <completion_date type="Anticipated">May 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 25, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Δ[HbO2]</measure>
    <time_frame>all groups: up to 4 weeks</time_frame>
    <description>the concentration changes of oxyhemoglobin (higher alternation means better curative effect)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Δ[Hb]</measure>
    <time_frame>all groups: up to 4 weeks</time_frame>
    <description>the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Δ[tHb]</measure>
    <time_frame>all groups: up to 4 weeks</time_frame>
    <description>the concentration changes of blood volume (higher alternation means better curative effect)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS</measure>
    <time_frame>experimental group: up to 4 weeks</time_frame>
    <description>Numeric Rating Scale for pain (lower score means better curative effect)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Oxygen Metabolism</condition>
  <condition>Muscle Spasticity</condition>
  <arm_group>
    <arm_group_label>dry cupping for patients of low back pain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive four consecutive dry cupping therapy application in one month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dry cupping for health people</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health people will receive four consecutive dry cupping therapy application in one month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Negative pressure therapy</intervention_name>
    <description>Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks</description>
    <arm_group_label>dry cupping for health people</arm_group_label>
    <arm_group_label>dry cupping for patients of low back pain</arm_group_label>
    <other_name>Dry cupping therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have had non-specific low back pains at least 12 weeks now.&#xD;
&#xD;
          -  Healthy people who are interested in dry cupping therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had non-specific low back pains at least 12 weeks now.&#xD;
&#xD;
          -  Healthy people who are interested in dry cupping therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have low back pain due to specific and known etiological causes&#xD;
             (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory&#xD;
             process, radicular syndrome, cauda equinal syndrome).&#xD;
&#xD;
          -  Patients who are inappropriate to the wet cupping treatment.&#xD;
&#xD;
               -  AIDS, Active Hepatitis, Tuberculosis, Syphilis&#xD;
&#xD;
               -  Patients who regularly take anticoagulants, antiplatelet drugs&#xD;
&#xD;
               -  Anemia, thrombocytopenia&#xD;
&#xD;
               -  Hemorrhagic disease like hemophilia&#xD;
&#xD;
               -  Diabetes&#xD;
&#xD;
               -  Severe cardiovascular disease&#xD;
&#xD;
               -  Kidney diseases (renal failure, chronic renal disease)&#xD;
&#xD;
          -  Patients who have experiences of wet cupping treatment during last 3 months.&#xD;
&#xD;
          -  Patients who have had treatment for low back pain during last 2 weeks.&#xD;
&#xD;
          -  Patients who are in pregnancy or have plan to conception.&#xD;
&#xD;
          -  Patients who have vertebra surgery or have plan of surgery.&#xD;
&#xD;
          -  Patients who are inappropriate to join this trial judged by the radiologists or&#xD;
             specialists.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ting Li</last_name>
    <phone>18002127296</phone>
    <email>t.li619@foxmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chenyang Gao</last_name>
    <phone>16622803399</phone>
    <email>gaocy@bme.cams.cn</email>
  </overall_contact_backup>
  <link>
    <url>https://www.osapublishing.org/boe/abstract.cfm?uri=boe-8-1-223</url>
    <description>Significant and sustaining elevation of blood oxygen induced by Chinese cupping therapy as assessed by near-infrared spectroscopy</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ting Li</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Cupping Therapy</keyword>
  <keyword>Near Infrared Spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <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/NCT03816787
org study id: NIRS for Cupping Therapy
nct id: NCT03816787
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on
      low back pain. 50 patients with low back pain as experimental group and 50 healthy people as
      control group are treated by DCT. They will receive four consecutive WCT application in one
      month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin
      ([HbO2]), deoxy-hemoglobin ([Hb]) and the derived change in blood volume ([tHb]) in/surround
      the cupping sites during treatment. The investigators hope to interpret the curative effect
      of DCT from the perspective of modern hemodynamics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Δ[HbO2]
time frame: all groups: up to 4 weeks
description: the concentration changes of oxyhemoglobin (higher alternation means better curative effect)
measure: Δ[Hb]
time frame: all groups: up to 4 weeks
description: the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)
measure: Δ[tHb]
time frame: all groups: up to 4 weeks
description: the concentration changes of blood volume (higher alternation means better curative effect)
measure: NRS
time frame: experimental group: up to 4 weeks
description: Numeric Rating Scale for pain (lower score means better curative effect)
arm group label: dry cupping for patients of low back pain
arm group type: Experimental
description: Patients will receive four consecutive dry cupping therapy application in one month.
arm group label: dry cupping for health people
arm group type: Active Comparator
description: Health people will receive four consecutive dry cupping therapy application in one month.
intervention type: Procedure
intervention name: Negative pressure therapy
description: Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks
arm group label: dry cupping for health people
arm group label: dry cupping for patients of low back pain
other name: Dry cupping therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ting Li
phone: 18002127296
email: t.li619@foxmail.com
last name: Chenyang Gao
phone: 16622803399
email: gaocy@bme.cams.cn
url: https://www.osapublishing.org/boe/abstract.cfm?uri=boe-8-1-223
description: Significant and sustaining elevation of blood oxygen induced by Chinese cupping therapy as assessed by near-infrared spectroscopy
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Ting Li
investigator title: Director
mesh term: Muscle Spasticity
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No