<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/NCT02983747</url>
  </required_header>
  <id_info>
    <org_study_id>201540379</org_study_id>
    <nct_id>NCT02983747</nct_id>
  </id_info>
  <brief_title>Autologous Platelet Rich Plasma on Low Back Pain</brief_title>
  <official_title>Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Changzheng Hospital</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>
      The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma&#xD;
      (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce&#xD;
      the pain feeling and benefit for restore of the intervertebral disk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale(VAS)</measure>
    <time_frame>1 year</time_frame>
    <description>Pain relief evaluated using change from baseline in Visual Analog Scale (VAS):baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>1 year</time_frame>
    <description>Pain relief and functions evaluated using change from baseline in Oswestry Disability Index (ODI): baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Rating Index</measure>
    <time_frame>1 year</time_frame>
    <description>Spinal functions evaluated using change from baseline by Functional Rating Index: baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the Quality of life using SF-36 questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Functions evaluated using change from baseline in SF-36:baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Imaging change</measure>
    <time_frame>1 year</time_frame>
    <description>Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with side effect</measure>
    <time_frame>Within 1 year after injection therapy</time_frame>
    <description>Record how many patients had side effects after intervention (eg.aggravation of pain*(VAS change increased more than 3 from baseline),anaphylaxis,sensory/motion disturbances).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>PRP Treatment(P)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medication Treatment(M)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NSAIDs medication(Loxoprofen Sodium tablets) therapy only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRP Treatment(P)</intervention_name>
    <description>Ultrasound(Philips® iU22 ultrasound system) guided intra-disk injection using 2 ml of platelet rich plasma, containing 0.2 ml of calcium chloride(SINE®, SHANGHAI XINYI PHARMACEUTIAL Co . Ltd .) per treatment</description>
    <arm_group_label>PRP Treatment(P)</arm_group_label>
    <other_name>Platelet Rich Plasma</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medication Treatment(Loxoprofen Sodium tablets,M)</intervention_name>
    <description>Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day</description>
    <arm_group_label>Medication Treatment(M)</arm_group_label>
    <arm_group_label>PRP Treatment(P)</arm_group_label>
    <other_name>LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic low back pain more than 2months&#xD;
&#xD;
          -  Visual analog scale score more than 4&#xD;
&#xD;
          -  Positive X-ray, MRI or CT scan findings&#xD;
&#xD;
          -  Pfirrmann grading I-III&#xD;
&#xD;
          -  Well understanding and communication ability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy&#xD;
&#xD;
          -  Hemorrhagic trend or use of anticoagulant therapy&#xD;
&#xD;
          -  Mental diseases&#xD;
&#xD;
          -  Active infection or recent infectious diseases within 3 months&#xD;
&#xD;
          -  Local skin infection near the puncture location&#xD;
&#xD;
          -  Severe lumbar spinal stenosis, lumbar spondylolisthesis, ossification of posterior&#xD;
             longitudinal&#xD;
&#xD;
          -  Ligament and lumbar disc herniation（more than 5mm）&#xD;
&#xD;
          -  Immunologic diseases&#xD;
&#xD;
          -  Tumors&#xD;
&#xD;
          -  Metastatic disease&#xD;
&#xD;
          -  Recent surgery less than 3 months)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xuhua Lu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Changzheng Hospotal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xuhua Lu, M.D.</last_name>
    <phone>86-21-81885793</phone>
    <email>xuhualu@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hai-bin Wang, M.D.</last_name>
    <phone>86-21-81885793</phone>
    <email>wanghb0222@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoguang Li, M.D.</last_name>
      <phone>86-21-81885045</phone>
      <email>Chzhhospital@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Xuhua Lu</investigator_full_name>
    <investigator_title>Vice Director of Spine Surgery</investigator_title>
  </responsible_party>
  <keyword>Platelet Rich Plasma</keyword>
  <keyword>Intervertebral Disk Injection Therapy</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Ultrasound Guided</keyword>
  <keyword>Degenerative Spinal Disease</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loxoprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02983747
org study id: 201540379
nct id: NCT02983747
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma
      (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce
      the pain feeling and benefit for restore of the intervertebral disk.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Visual Analog Scale(VAS)
time frame: 1 year
description: Pain relief evaluated using change from baseline in Visual Analog Scale (VAS):baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
measure: Oswestry Disability Index (ODI)
time frame: 1 year
description: Pain relief and functions evaluated using change from baseline in Oswestry Disability Index (ODI): baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
measure: Functional Rating Index
time frame: 1 year
description: Spinal functions evaluated using change from baseline by Functional Rating Index: baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
measure: Measuring the Quality of life using SF-36 questionnaire
time frame: 1 year
description: Functions evaluated using change from baseline in SF-36:baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
measure: Imaging change
time frame: 1 year
description: Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.
measure: Number of patients with side effect
time frame: Within 1 year after injection therapy
description: Record how many patients had side effects after intervention (eg.aggravation of pain*(VAS change increased more than 3 from baseline),anaphylaxis,sensory/motion disturbances).
arm group label: PRP Treatment(P)
arm group type: Experimental
description: PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
arm group label: Medication Treatment(M)
arm group type: Active Comparator
description: NSAIDs medication(Loxoprofen Sodium tablets) therapy only.
intervention type: Other
intervention name: PRP Treatment(P)
description: Ultrasound(Philips® iU22 ultrasound system) guided intra-disk injection using 2 ml of platelet rich plasma, containing 0.2 ml of calcium chloride(SINE®, SHANGHAI XINYI PHARMACEUTIAL Co . Ltd .) per treatment
arm group label: PRP Treatment(P)
other name: Platelet Rich Plasma
intervention type: Drug
intervention name: Medication Treatment(Loxoprofen Sodium tablets,M)
description: Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
arm group label: Medication Treatment(M)
arm group label: PRP Treatment(P)
other name: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Xuhua Lu, M.D.
role: Principal Investigator
affiliation: Shanghai Changzheng Hospotal
last name: Xuhua Lu, M.D.
phone: 86-21-81885793
email: xuhualu@hotmail.com
last name: Hai-bin Wang, M.D.
phone: 86-21-81885793
email: wanghb0222@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Xuhua Lu
investigator title: Vice Director of Spine Surgery
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Loxoprofen
sharing ipd: Undecided