<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/NCT02983201</url>
  </required_header>
  <id_info>
    <org_study_id>UW13-348</org_study_id>
    <nct_id>NCT02983201</nct_id>
  </id_info>
  <brief_title>A Clinical Study of Acupuncture Comprehensive Therapy on Common Orthopedic Pain Syndromes</brief_title>
  <official_title>A Clinical Study of Acupuncture Comprehensive Therapy on Common Orthopedic Pain Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this trial is to further confirm and assess the efficacy of filiform needle&#xD;
      therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack&#xD;
      needle therapy could further enhance the clinical efficacy and pain healing effect of the&#xD;
      filiform needle therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thumbtack Intra-dermal Needle is a type of intra-dermal needle with a round thumbtack like&#xD;
      needle head that is perpendicular to the needle and its sharp end. It is also named as&#xD;
      Push-pin Intra-dermal Needle. The Thumbtack Intra-dermal Needle is designed to be embedded in&#xD;
      the dermal part of the patients'body for a prolong period to provide continuous stimulation,&#xD;
      it is a further development of the treatment method of retaining the filiform needle in the&#xD;
      patients'body. The main purpose of embedding the needle in the patients' body for a prolong&#xD;
      period of time is to enhance the effect of acupuncture, and improve its clinical efficacy.&#xD;
      After the Thumbtack Intra-dermal Needle is applied to the acupuncture point, the needle will&#xD;
      be fastened by adhesive tape on the skin surface, and embedded in the dermal part of the&#xD;
      patient's body for a period of time. Currently, Thumbtack Intra-dermal Needle is widely used&#xD;
      in clinical application. On April 23, 2008, the State Administration of Quality Supervision,&#xD;
      Inspection and Quarantine of the People's Republic of China, together with the China National&#xD;
      Standardization Management Committee, released the GB standard of applying Intra-dermal&#xD;
      Needle: The national standard of the People's Republic of China - Acupuncture and Practices,&#xD;
      Part 8: Intra-dermal Needle (GB/T 21709. 8-2008).&#xD;
&#xD;
      Filiform needle is the most common needle used for acupuncture, and it is commonly accepted&#xD;
      as the primary tool to perform acupuncture. Traditional Acupuncture (using filiform needle)is&#xD;
      proven to be effective in pain management. In 2003, World Health Organization(WHO) confirmed&#xD;
      that &quot;There is significant neurophysiological evidence that supports the the notion that&#xD;
      acupuncture is capable of modulating pain sensation&quot;. Relatively fewer research and study has&#xD;
      been done on efficacy of Intra-dermal needle in pain management.&#xD;
&#xD;
      The objective of this trial is to further confirm and assess the efficacy of filiform needle&#xD;
      therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack&#xD;
      needle therapy could further enhance the clinical efficacy and pain healing effect of the&#xD;
      filiform needle therapy.&#xD;
&#xD;
      150 outpatients diagnosed with common orthopedic pain syndromes (Coracoiditis, External&#xD;
      humeral epicondylitis, Radial styloid process stenosing tenosynovitis, Flexor tendon&#xD;
      stenosing tenosynovitis, Costochondritis and Supraspinal ligament injury) will be recruited.&#xD;
      The recruited patient will be divided randomly into (i)Filiform Needle Group (75 cases) and&#xD;
      (ii)Filiform Needle supplemented by Thumbtack Intra-dermal Needle Group (75cases) by using&#xD;
      computer generated random number.&#xD;
&#xD;
      During the study period, a maximum of two courses of acupuncture therapy, consisting of 7&#xD;
      sessions each, will be administered. Treatment will be given twice per week. After completing&#xD;
      the first course of 7 sessions, there will be a break of one week, at the end of which the&#xD;
      second course will commence. Treatment will come to a halt as soon as the pain has totally&#xD;
      subsided. The aim of treatment is to relieve the pain associated with the common orthopedic&#xD;
      syndrome within the shortest period of time.&#xD;
&#xD;
      Questionnaire incorporating The Short-form McGill Pain Form and selected life efficacy&#xD;
      questions will be used in this study to quantify the level of pain. Traditional Chinese&#xD;
      Medicine(TCM) Syndrome Diagnostic Efficacy Standards and The Guiding Rules of Clinical&#xD;
      Research of New Chinese Medicine will be adopted as the standard to observe and evaluate the&#xD;
      efficacy of treatment. Patients will be observed and evaluate before and after each treatment&#xD;
      and each treatment course. The subjects' level and intensity of pain will be recorded&#xD;
      together with the improvement of body mobility and symptoms related to the pain. Follow up&#xD;
      will take place 3 months, 6 months and 12 months after treatment completed through phone&#xD;
      interview.&#xD;
&#xD;
      Data collected will be analysed by Statistical Product and Service Solutions(SPSS)&#xD;
      statistical software, The efficacy of Filiform Needle Therapy and Thumbtack Needle Therapy on&#xD;
      Common Orthopedic Pain Syndromes will be objectively assessed and compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Change of score on Mcgill pain form (SF)</measure>
    <time_frame>1 week</time_frame>
    <description>The change of Score on Mcgill pain form (SF) between baseline and after the 7th treatment will be measured and compared between groups. Should the patient terminate treatment before the 7th treatment, (due to any reason including cure and drop out), the score of the last treatment will be used for analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of pain intensity on visual analogue scale (VAS) (1-10)</measure>
    <time_frame>1 week</time_frame>
    <description>The change of pain score on VAS scale between baseline and after the 7th treatment will be measured and compared between groups. Should the patient terminate treatment before the 7th treatment, (due to any reason including cure and drop out), the score of the last treatment will be used for analysis. Follow up phone call will be conducted 3 months after the treatment completed for all patients. The VAS score of the treatment position will be recorded to understand the pain remission pattern between groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The improvement of clinical signs and symptoms</measure>
    <time_frame>1 week</time_frame>
    <description>The improvement of clinical signs and symptoms will be compared between groups. The following standard is used to classify improvement of clinical signs and symptoms&#xD;
Clinically cured: the overall improvement rate of the main symptoms and signs≧95%, normal joint movement.&#xD;
Significantly improved: the overall improvement rate of the main symptoms and signs≧70%, the joint activities are not limited.&#xD;
Improved: the overall improvement rate of the main symptoms and signs≧30%, &lt;70%，the Joint activities have been improved.&#xD;
Inefficacy: the overall improvement rate of the main symptoms and signs &lt;30%, the Joint activities have not been improved.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>filiform needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>thumbtack needle+filiform needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>filiform needle</intervention_name>
    <description>Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.</description>
    <arm_group_label>filiform needle</arm_group_label>
    <arm_group_label>thumbtack needle+filiform needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>thumbtack needle</intervention_name>
    <description>Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.</description>
    <arm_group_label>thumbtack needle+filiform needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a. Age:&gt;18 years old&#xD;
&#xD;
          -  b. Gender: male or female&#xD;
&#xD;
          -  c. Duration: not restricted&#xD;
&#xD;
          -  d. Comply with Western medicine diagnostic criteria.&#xD;
&#xD;
          -  e. Signed the Patient/Subject Consent Form for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a. The disease is not comply with Western diagnostic criteria.&#xD;
&#xD;
          -  b. The disease is outside the range of this study.&#xD;
&#xD;
          -  c. Acute disease activity phase.&#xD;
&#xD;
          -  d. Skin swelling, skin infection, skin active ulcer disease, or local purpura and&#xD;
             scar.&#xD;
&#xD;
          -  e. Patients with skin allergies, bleeding disorders&#xD;
&#xD;
          -  f. Pregnancy, lactating women.&#xD;
&#xD;
          -  g. Application of other therapy, the disease has been or is gradually improving.&#xD;
&#xD;
          -  h. Chronic wasting disease.&#xD;
&#xD;
          -  i. Severe primary diseases of the liver, kidney, hematopoietic system and -endocrine&#xD;
             system,&#xD;
&#xD;
          -  j. Mental illness.&#xD;
&#xD;
          -  k. With other severe diseases, it is difficult to exact evaluate the efficacy and&#xD;
             safety of acupuncture.&#xD;
&#xD;
          -  l. Not signed the Patient/Subject Consent Form for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li</last_name>
    <phone>852-39176424</phone>
    <email>llie@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Clara Chan</last_name>
    <phone>852-98323934</phone>
    <email>patcla@netvigator.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>School of Chinese Medicine, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clara Chan</last_name>
      <phone>852-98323934</phone>
      <email>patcla@netvigator.com</email>
    </contact>
    <investigator>
      <last_name>Lei Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Orthopedic Pain Syndromes</keyword>
  <keyword>Thumbtack Intra-dermal Needle</keyword>
  <keyword>Filiform needle</keyword>
  <keyword>Acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT02983201
org study id: UW13-348
nct id: NCT02983201
lead sponsor: 
has dmc: Yes
The objective of this trial is to further confirm and assess the efficacy of filiform needle
      therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack
      needle therapy could further enhance the clinical efficacy and pain healing effect of the
      filiform needle therapy.
Thumbtack Intra-dermal Needle is a type of intra-dermal needle with a round thumbtack like
      needle head that is perpendicular to the needle and its sharp end. It is also named as
      Push-pin Intra-dermal Needle. The Thumbtack Intra-dermal Needle is designed to be embedded in
      the dermal part of the patients'body for a prolong period to provide continuous stimulation,
      it is a further development of the treatment method of retaining the filiform needle in the
      patients'body. The main purpose of embedding the needle in the patients' body for a prolong
      period of time is to enhance the effect of acupuncture, and improve its clinical efficacy.
      After the Thumbtack Intra-dermal Needle is applied to the acupuncture point, the needle will
      be fastened by adhesive tape on the skin surface, and embedded in the dermal part of the
      patient's body for a period of time. Currently, Thumbtack Intra-dermal Needle is widely used
      in clinical application. On April 23, 2008, the State Administration of Quality Supervision,
      Inspection and Quarantine of the People's Republic of China, together with the China National
      Standardization Management Committee, released the GB standard of applying Intra-dermal
      Needle: The national standard of the People's Republic of China - Acupuncture and Practices,
      Part 8: Intra-dermal Needle (GB/T 21709. 8-2008).

      Filiform needle is the most common needle used for acupuncture, and it is commonly accepted
      as the primary tool to perform acupuncture. Traditional Acupuncture (using filiform needle)is
      proven to be effective in pain management. In 2003, World Health Organization(WHO) confirmed
      that "There is significant neurophysiological evidence that supports the the notion that
      acupuncture is capable of modulating pain sensation". Relatively fewer research and study has
      been done on efficacy of Intra-dermal needle in pain management.

      The objective of this trial is to further confirm and assess the efficacy of filiform needle
      therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack
      needle therapy could further enhance the clinical efficacy and pain healing effect of the
      filiform needle therapy.

      150 outpatients diagnosed with common orthopedic pain syndromes (Coracoiditis, External
      humeral epicondylitis, Radial styloid process stenosing tenosynovitis, Flexor tendon
      stenosing tenosynovitis, Costochondritis and Supraspinal ligament injury) will be recruited.
      The recruited patient will be divided randomly into (i)Filiform Needle Group (75 cases) and
      (ii)Filiform Needle supplemented by Thumbtack Intra-dermal Needle Group (75cases) by using
      computer generated random number.

      During the study period, a maximum of two courses of acupuncture therapy, consisting of 7
      sessions each, will be administered. Treatment will be given twice per week. After completing
      the first course of 7 sessions, there will be a break of one week, at the end of which the
      second course will commence. Treatment will come to a halt as soon as the pain has totally
      subsided. The aim of treatment is to relieve the pain associated with the common orthopedic
      syndrome within the shortest period of time.

      Questionnaire incorporating The Short-form McGill Pain Form and selected life efficacy
      questions will be used in this study to quantify the level of pain. Traditional Chinese
      Medicine(TCM) Syndrome Diagnostic Efficacy Standards and The Guiding Rules of Clinical
      Research of New Chinese Medicine will be adopted as the standard to observe and evaluate the
      efficacy of treatment. Patients will be observed and evaluate before and after each treatment
      and each treatment course. The subjects' level and intensity of pain will be recorded
      together with the improvement of body mobility and symptoms related to the pain. Follow up
      will take place 3 months, 6 months and 12 months after treatment completed through phone
      interview.

      Data collected will be analysed by Statistical Product and Service Solutions(SPSS)
      statistical software, The efficacy of Filiform Needle Therapy and Thumbtack Needle Therapy on
      Common Orthopedic Pain Syndromes will be objectively assessed and compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of score on Mcgill pain form (SF)
time frame: 1 week
description: The change of Score on Mcgill pain form (SF) between baseline and after the 7th treatment will be measured and compared between groups. Should the patient terminate treatment before the 7th treatment, (due to any reason including cure and drop out), the score of the last treatment will be used for analysis.
measure: Change of pain intensity on visual analogue scale (VAS) (1-10)
time frame: 1 week
description: The change of pain score on VAS scale between baseline and after the 7th treatment will be measured and compared between groups. Should the patient terminate treatment before the 7th treatment, (due to any reason including cure and drop out), the score of the last treatment will be used for analysis. Follow up phone call will be conducted 3 months after the treatment completed for all patients. The VAS score of the treatment position will be recorded to understand the pain remission pattern between groups
measure: The improvement of clinical signs and symptoms
time frame: 1 week
description: The improvement of clinical signs and symptoms will be compared between groups. The following standard is used to classify improvement of clinical signs and symptoms
Clinically cured: the overall improvement rate of the main symptoms and signs≧95%, normal joint movement.
Significantly improved: the overall improvement rate of the main symptoms and signs≧70%, the joint activities are not limited.
Improved: the overall improvement rate of the main symptoms and signs≧30%, <70%，the Joint activities have been improved.
Inefficacy: the overall improvement rate of the main symptoms and signs <30%, the Joint activities have not been improved.
arm group label: filiform needle
arm group type: Active Comparator
description: Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
arm group label: thumbtack needle+filiform needle
arm group type: Experimental
description: Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
intervention type: Other
intervention name: filiform needle
description: Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
arm group label: filiform needle
arm group label: thumbtack needle+filiform needle
intervention type: Other
intervention name: thumbtack needle
description: Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
arm group label: thumbtack needle+filiform needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lei Li
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Lei Li
phone: 852-39176424
email: llie@hku.hk
last name: Clara Chan
phone: 852-98323934
email: patcla@netvigator.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Syndrome
sharing ipd: Undecided