<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/NCT03282630</url>
  </required_header>
  <id_info>
    <org_study_id>TR-acupuncture-2</org_study_id>
    <nct_id>NCT03282630</nct_id>
  </id_info>
  <brief_title>The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis</brief_title>
  <official_title>The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren 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>
      Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in&#xD;
      treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG&#xD;
      acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind,&#xD;
      controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants&#xD;
      will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group.&#xD;
      All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of&#xD;
      4 week.&#xD;
&#xD;
      Primary trial outcomes are change in symptoms and change in need for medication. The primary&#xD;
      outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.&#xD;
      Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal&#xD;
      cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in&#xD;
      neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory&#xD;
      cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis&#xD;
      factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal&#xD;
      secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1,&#xD;
      week4 and week 8.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2016</start_date>
  <completion_date type="Actual">February 20, 2017</completion_date>
  <primary_completion_date type="Actual">January 16, 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>The change of symptoms</measure>
    <time_frame>The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.</time_frame>
    <description>The participants will document the four nasal symptoms (nasal obstruction, rhinorrhea, sneezing, and itching) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a four-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The weekly TNSS will be calculated and compared between the groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of need for medication</measure>
    <time_frame>The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.</time_frame>
    <description>Participants will be asked not to use drugs as much as possible. If drugs are used to relieve symptoms, Medication need will be measured using rescue medication score (RMS), comprising the weekly sum of daily assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of nasal patency</measure>
    <time_frame>The outcomes will be measured in baseline, week1, week4 and week 8.</time_frame>
    <description>Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³) and Rhinomanometer was used to measure the total nasal airway resistance (Pa·cm-³·s-1) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of exhaled nasal nitric oxide</measure>
    <time_frame>The outcomes will be measured in baseline, week1, week4 and week 8.</time_frame>
    <description>The change of exhaled nasal nitric oxide assessed by nitric oxide analyser. A nitric oxide analyser was used to measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions</measure>
    <time_frame>The outcomes will be measured in baseline, week1, week4 and week 8.</time_frame>
    <description>The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of substance P(pg/ml), vasoactive intestinal peptide (ng/ml) and neuropeptide Y (pg/ml) were analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of inflammatory cytokines in nasal secretions</measure>
    <time_frame>The outcomes will be measured in baseline, week1, week4 and week 8.</time_frame>
    <description>The change of inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of inflammatory cytokines (pg/ml) were analysed using the Luminex System.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Patients</condition>
  <arm_group>
    <arm_group_label>active acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure/Surgery: active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process and temporal process. The needle was rotated until the participant felt &quot;de-qi&quot; sensations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Procedure/Surgery: Sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sphenopalatine ganglion acupuncture</intervention_name>
    <description>active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process&#xD;
sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.</description>
    <arm_group_label>active acupuncture</arm_group_label>
    <arm_group_label>sham acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a history of at least 2 years of seasonal allergic rhinitis&#xD;
&#xD;
          -  no smoking&#xD;
&#xD;
          -  without history of nasal polyps, nasal septum deviation and history of nose surgery)&#xD;
             or lung disease (asthma, chronic obstructive pulmonary disease and fibrosis)&#xD;
&#xD;
          -  free of upper and lower respiratory tract infections for at least 4 weeks before&#xD;
             beginning the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had received acupuncture within the last four weeks before the study&#xD;
&#xD;
          -  history of diabetes mellitus, autonomic neuropathy, coronary heart disease or&#xD;
             hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chengshuo Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tongren Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013 Mar;68(3):365-74. doi: 10.1111/all.12053. Epub 2012 Dec 18.</citation>
    <PMID>23253122</PMID>
  </reference>
  <reference>
    <citation>Xue CC, Zhang AL, Zhang CS, DaCosta C, Story DF, Thien FC. Acupuncture for seasonal allergic rhinitis: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Oct;115(4):317-324.e1. doi: 10.1016/j.anai.2015.05.017. Epub 2015 Jun 11.</citation>
    <PMID>26073163</PMID>
  </reference>
  <reference>
    <citation>Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.</citation>
    <PMID>23420231</PMID>
  </reference>
  <reference>
    <citation>Wang K, Chen L, Wang Y, Wang C, Zhang L. Sphenopalatine Ganglion Acupuncture Improves Nasal Ventilation and Modulates Autonomic Nervous Activity in Healthy Volunteers: A Randomized Controlled Study. Sci Rep. 2016 Jul 18;6:29947. doi: 10.1038/srep29947.</citation>
    <PMID>27425415</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Sphenopalatine ganglion</keyword>
  <keyword>Allergic rhinitis</keyword>
  <keyword>Randomized Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Ganglion Cysts</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</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/NCT03282630
org study id: TR-acupuncture-2
nct id: NCT03282630
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in
      treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG
      acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind,
      controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants
      will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group.
      All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of
      4 week.

      Primary trial outcomes are change in symptoms and change in need for medication. The primary
      outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.
      Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal
      cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in
      neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory
      cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis
      factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal
      secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1,
      week4 and week 8.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The change of symptoms
time frame: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.
description: The participants will document the four nasal symptoms (nasal obstruction, rhinorrhea, sneezing, and itching) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a four-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The weekly TNSS will be calculated and compared between the groups.
measure: The change of need for medication
time frame: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.
description: Participants will be asked not to use drugs as much as possible. If drugs are used to relieve symptoms, Medication need will be measured using rescue medication score (RMS), comprising the weekly sum of daily assessments.
measure: The change of nasal patency
time frame: The outcomes will be measured in baseline, week1, week4 and week 8.
description: Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³) and Rhinomanometer was used to measure the total nasal airway resistance (Pa·cm-³·s-1) .
measure: The change of exhaled nasal nitric oxide
time frame: The outcomes will be measured in baseline, week1, week4 and week 8.
description: The change of exhaled nasal nitric oxide assessed by nitric oxide analyser. A nitric oxide analyser was used to measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s.
measure: The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions
time frame: The outcomes will be measured in baseline, week1, week4 and week 8.
description: The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of substance P(pg/ml), vasoactive intestinal peptide (ng/ml) and neuropeptide Y (pg/ml) were analysed.
measure: The change of inflammatory cytokines in nasal secretions
time frame: The outcomes will be measured in baseline, week1, week4 and week 8.
description: The change of inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of inflammatory cytokines (pg/ml) were analysed using the Luminex System.
arm group label: active acupuncture
arm group type: Experimental
description: Procedure/Surgery: active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process and temporal process. The needle was rotated until the participant felt "de-qi" sensations.
arm group label: sham acupuncture
arm group type: Sham Comparator
description: Procedure/Surgery: Sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.
intervention type: Procedure
intervention name: Sphenopalatine ganglion acupuncture
description: active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process
sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.
arm group label: active acupuncture
arm group label: sham acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Chengshuo Wang
role: Principal Investigator
affiliation: Beijing Tongren Hospital
facility: 
country: China
citation: Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013 Mar;68(3):365-74. doi: 10.1111/all.12053. Epub 2012 Dec 18.
PMID: 23253122
citation: Xue CC, Zhang AL, Zhang CS, DaCosta C, Story DF, Thien FC. Acupuncture for seasonal allergic rhinitis: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Oct;115(4):317-324.e1. doi: 10.1016/j.anai.2015.05.017. Epub 2015 Jun 11.
PMID: 26073163
citation: Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.
PMID: 23420231
citation: Wang K, Chen L, Wang Y, Wang C, Zhang L. Sphenopalatine Ganglion Acupuncture Improves Nasal Ventilation and Modulates Autonomic Nervous Activity in Healthy Volunteers: A Randomized Controlled Study. Sci Rep. 2016 Jul 18;6:29947. doi: 10.1038/srep29947.
PMID: 27425415
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Ganglion Cysts
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal