<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/NCT03274713</url>
  </required_header>
  <id_info>
    <org_study_id>2017BL-020-01</org_study_id>
    <nct_id>NCT03274713</nct_id>
  </id_info>
  <brief_title>Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis</brief_title>
  <official_title>Efficacy of Electro-acupuncture Versus Manual Acupuncture for Knee Osteoarthritis: a Randomized Controlled Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>zhouping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Jishuitan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Hospital of Traditional Chinese Medicine</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>
      Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common&#xD;
      bone and joint diseases in clinic. It often occurs in middle-aged people, especially women.&#xD;
      It was estimated to affect more than 9 million individuals in the United States in 2005 and&#xD;
      is a leading cause of disability and medical costs. Most elderly people over the age of 65&#xD;
      have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which&#xD;
      can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or&#xD;
      disability.According to the papers published in the past years, we find that acupuncture&#xD;
      therapy for the treatment of knee osteoarthritis include manual acupuncture,&#xD;
      electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual&#xD;
      acupuncture and electro-acupuncture are most commonly used.The aim of this study is to&#xD;
      compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and&#xD;
      improving function in patients with KOA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomly allocated to one of two groups. Those in the first group&#xD;
      receive electro-acupuncture, which involves having needles inserted into acupuncture points&#xD;
      (locations on the body affected by acupuncture) which are stimulated manually for 10 seconds&#xD;
      to create &quot;De Qi&quot; sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator,&#xD;
      Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) was then connected to the&#xD;
      needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10.&#xD;
      The stimulus intensity will be increased until the patient reported a strong but comfortable&#xD;
      intensity. Those in the second group have the same schedule as the electro-acupuncture group&#xD;
      except that the electrical apparatus has working power indicator and sound without actual&#xD;
      current output. Both groups will receive 30-minute, 24 sessions intervention over eight&#xD;
      weeks. Moreover, a number of questionnaires at the start of the study and then again after 4,&#xD;
      8, 12 and 16 week will be completed by participants.&#xD;
&#xD;
      It is expected that participants will benefit from a decrease in pain and improved function.&#xD;
      The risks of participation are minimal. Occasionally, acupuncture can make people feel&#xD;
      nauseous or experience a temporary increase in pain either during or after treatment. Rare&#xD;
      side effects during acupuncture treatment include fainting, infection and subcutaneous&#xD;
      hematoma (pooling of blood under the skin). Participants will be warned of these potential&#xD;
      side-effects before consenting to have acupuncture.&#xD;
&#xD;
      Participants will be allowed, or required, to withdraw from the trial based on the following:&#xD;
&#xD;
        1. A major protocol violation;&#xD;
&#xD;
        2. Development of a serious disease preventing continuation in the trial;&#xD;
&#xD;
        3. Adverse events related to acupuncture;&#xD;
&#xD;
        4. Request to be withdrawn from the trial. The purpose is to accumulate clinical data,&#xD;
           obtain the outcome data of the intervention method and prove the feasibility of the&#xD;
           study protocol. Sixty patients will be selected as the sample size according to clinical&#xD;
           experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">February 28, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>Success Rate</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks</time_frame>
    <description>using WOMAC pain subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stiffness</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks</time_frame>
    <description>using WOMAC stiffness subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee-joint function</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks</time_frame>
    <description>using WOMAC functional subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks</time_frame>
    <description>using the 12-Item Short Form Health Survey (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency analgesics (Celebrex/Loxonin) used</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks</time_frame>
    <description>using Drug Use Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Luminex liquid chip method (LuminexxMAP, Technology, USA) Bio-plex200 system high throughput analysis platform (Bio-Rad) will be used to detect the expression of free protein in serum. Patients will receive fasting blood samples in the morning and then be centrifuged with 3000r/min, 15min in two hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility/expectancy questionnaires</measure>
    <time_frame>baseline</time_frame>
    <description>Credibility/expectancy questionnaires are used to assess the credibility and expectancy of the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>using Adverse Event Form</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Osteoarthritis Of Knee</condition>
  <arm_group>
    <arm_group_label>Electro-acupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After recruiting, patients are assigned to the electro-acupuncture group by randomization,and then receive electro-acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual acupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After recruiting, patients are assigned to the manual acupuncture group by randomization,and then receive manual acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electro-acupuncture</intervention_name>
    <description>Patients in this group will be treated by use of 6-7 local acupuncture points (ST34, ST35, ST36, EX-LE2, EX-LE5, GB33, GB34, SP9, SP10, LR7, LR8 and Ashi) and 2-3 distal points (GB31, GB36, GB39, GB41, ST40, ST41, LR3, BL60, SP6 and KI3). Needles will be stimulated manually for 10 seconds to achieve &quot;De Qi&quot; sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) will be then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity.</description>
    <arm_group_label>Electro-acupuncture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manual acupuncture</intervention_name>
    <description>Participants in the group have the same schedule as the electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output.</description>
    <arm_group_label>Manual acupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 45-75 years old, male or female&#xD;
&#xD;
          -  Single / bilateral knee pain, duration of more than 6 months&#xD;
&#xD;
          -  KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ&#xD;
&#xD;
          -  VAS ≥ 40mm&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)&#xD;
&#xD;
          -  History of arthroscopy within 1 year or intra-articular injection within 4 months&#xD;
&#xD;
          -  Knee pain caused by other diseases (such as joint bodies, severe effusion of joint&#xD;
             cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.)&#xD;
&#xD;
          -  Severe acute/chronic organic or mental diseases&#xD;
&#xD;
          -  Coagulation disorders (such as hemophilia, etc.)&#xD;
&#xD;
          -  Pregnant women, pregnant and lactating women&#xD;
&#xD;
          -  History of receiving acupuncture or massage treatment within one month&#xD;
&#xD;
          -  Participation in another clinical study in the past 3 months&#xD;
&#xD;
          -  With a cardiac pacemaker, metal allergy or needle phobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cunzhi Liu, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cunzhi Liu, M.D</last_name>
    <phone>010-52176043</phone>
    <email>lcz623780@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yongting Li, Postgraduate Student</last_name>
    <phone>15210518799</phone>
    <email>liyong_ting@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>zhouping</investigator_full_name>
    <investigator_title>Postgraduate Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_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/NCT03274713
org study id: 2017BL-020-01
nct id: NCT03274713
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common
      bone and joint diseases in clinic. It often occurs in middle-aged people, especially women.
      It was estimated to affect more than 9 million individuals in the United States in 2005 and
      is a leading cause of disability and medical costs. Most elderly people over the age of 65
      have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which
      can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or
      disability.According to the papers published in the past years, we find that acupuncture
      therapy for the treatment of knee osteoarthritis include manual acupuncture,
      electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual
      acupuncture and electro-acupuncture are most commonly used.The aim of this study is to
      compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and
      improving function in patients with KOA.
Participants will be randomly allocated to one of two groups. Those in the first group
      receive electro-acupuncture, which involves having needles inserted into acupuncture points
      (locations on the body affected by acupuncture) which are stimulated manually for 10 seconds
      to create "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator,
      Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) was then connected to the
      needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10.
      The stimulus intensity will be increased until the patient reported a strong but comfortable
      intensity. Those in the second group have the same schedule as the electro-acupuncture group
      except that the electrical apparatus has working power indicator and sound without actual
      current output. Both groups will receive 30-minute, 24 sessions intervention over eight
      weeks. Moreover, a number of questionnaires at the start of the study and then again after 4,
      8, 12 and 16 week will be completed by participants.

      It is expected that participants will benefit from a decrease in pain and improved function.
      The risks of participation are minimal. Occasionally, acupuncture can make people feel
      nauseous or experience a temporary increase in pain either during or after treatment. Rare
      side effects during acupuncture treatment include fainting, infection and subcutaneous
      hematoma (pooling of blood under the skin). Participants will be warned of these potential
      side-effects before consenting to have acupuncture.

      Participants will be allowed, or required, to withdraw from the trial based on the following:

        1. A major protocol violation;

        2. Development of a serious disease preventing continuation in the trial;

        3. Adverse events related to acupuncture;

        4. Request to be withdrawn from the trial. The purpose is to accumulate clinical data,
           obtain the outcome data of the intervention method and prove the feasibility of the
           study protocol. Sixty patients will be selected as the sample size according to clinical
           experience.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Success Rate
time frame: baseline, 8 weeks
description: a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks.
measure: Pain
time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
description: using WOMAC pain subscale
measure: Stiffness
time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
description: using WOMAC stiffness subscale
measure: Knee-joint function
time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
description: using WOMAC functional subscale
measure: Quality of life
time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
description: using the 12-Item Short Form Health Survey (SF-12)
measure: Number of emergency analgesics (Celebrex/Loxonin) used
time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
description: using Drug Use Form
measure: Inflammatory markers
time frame: baseline, 8 weeks
description: Luminex liquid chip method (LuminexxMAP, Technology, USA) Bio-plex200 system high throughput analysis platform (Bio-Rad) will be used to detect the expression of free protein in serum. Patients will receive fasting blood samples in the morning and then be centrifuged with 3000r/min, 15min in two hours.
measure: Credibility/expectancy questionnaires
time frame: baseline
description: Credibility/expectancy questionnaires are used to assess the credibility and expectancy of the patients
measure: Adverse events
time frame: up to 16 weeks
description: using Adverse Event Form
arm group label: Electro-acupuncture group
arm group type: Experimental
description: After recruiting, patients are assigned to the electro-acupuncture group by randomization,and then receive electro-acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
arm group label: Manual acupuncture group
arm group type: Experimental
description: After recruiting, patients are assigned to the manual acupuncture group by randomization,and then receive manual acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
intervention type: Device
intervention name: Electro-acupuncture
description: Patients in this group will be treated by use of 6-7 local acupuncture points (ST34, ST35, ST36, EX-LE2, EX-LE5, GB33, GB34, SP9, SP10, LR7, LR8 and Ashi) and 2-3 distal points (GB31, GB36, GB39, GB41, ST40, ST41, LR3, BL60, SP6 and KI3). Needles will be stimulated manually for 10 seconds to achieve "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) will be then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity.
arm group label: Electro-acupuncture group
intervention type: Device
intervention name: Manual acupuncture
description: Participants in the group have the same schedule as the electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output.
arm group label: Manual acupuncture group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Cunzhi Liu, M.D
role: Study Director
affiliation: Beijing Hospital of Traditional Chinese Medicine
last name: Cunzhi Liu, M.D
phone: 010-52176043
email: lcz623780@126.com
last name: Yongting Li, Postgraduate Student
phone: 15210518799
email: liyong_ting@126.com
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Beijing Hospital of Traditional Chinese Medicine
investigator full name: zhouping
investigator title: Postgraduate Student
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided