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Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT04052945
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Luo Zhang, Beijing Tongren Hospital

Brief Summary:

In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.

In conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.

The investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in pollen-induced seasonal AR patients and to explore the potential underlying mechanisms.


Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Procedure: SPA acupuncture Procedure: sham acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo Controlled Study
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SPA acupuncture
active SPG acupuncture plus rescue medication (AA group)
Procedure: SPA acupuncture

For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt "de-qi" sensations .

The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).


Sham Comparator: sham acupuncture
sham-SPG acupuncture plus rescue medication (SA group)
Procedure: sham acupuncture

For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle.

The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).





Primary Outcome Measures :
  1. Change from baseline symptom scores at visit 4 [ Time Frame: Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is at the second week 30minutes after the fourth acupuncture. ]
    Patients recorded nasal and ocular symptom severity during the trial. Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were individually graded on a ten-point scale (0, no symptoms; 1-3, mild symptoms; 4-7, moderate symptoms; 8-10, severe symptoms). Our primary outcome is total nasal symptom scores at Visit 4 (30 minutes after the fourth acupuncture ). The investigator will compare the symptom scores between the active acupuncture group and the sham acupuncture group.


Secondary Outcome Measures :
  1. Rescue medication score [ Time Frame: RMS will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6 ]
    when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication. The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)

  2. SNOT-22 [ Time Frame: SNOT-22 will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6. ]
    SNOT-22 is assessed to evaluate the quality of life of the SAR patients.

  3. nasal patency [ Time Frame: NCV, NAR and MCA will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively. V5 is at the third week and V6 is at the fourth week. There is no acupunc ]
    Eccovision acoustic rhinometry (Hood Labs, Pembroke, USA) was used to measure the total nasal cavity volume (NCV) and minimum cross-sectional area (MCA). The ATMO 300 Rhinomanometer (ATMOS MedizinTechnikGmbH&Co., Feldkirch, Germany) was used to measure the nasal airway resistance (NAR) by anterior active rhinomanometry.

  4. fractional exhaled nasal nitric oxide (FeNO) [ Time Frame: FeNO is assessed at baseline (V0), and each visit. V1, V2,V3,V4 are four visits for acupunctures during the first and the second weeks. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6. ]
    FeNO is assessed by nitric oxide analyzer and this endpoint is a marker of eosinophilic inflammation in the nose.

  5. neuropeptides in nasal secretions [ Time Frame: Nasal secretions can be obtained at baseline (V0), V4,V5 and V6. V4 is at the second week. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6. ]
    The levels of neuropeptides; including substance P, vasoactive intestinal peptide (VIP) , neuropeptide Y (NPY)) will be analysed using ELISA.

  6. inflammatory cytokines in nasal secretions [ Time Frame: Nasal secretions can be obtained at baseline (V0), V4 ,V5 and V6. V4 is at the second week. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6. ]
    The levels of inflammatory cytokines; including interferon-γ (IFN-γ), tumor necrosis factor-α(TNF-α), interleukin (IL)-5, IL-8, IL-17A, and eotaxin in the supernatants will be analyzed using the Luminex System.

  7. adverse events [ Time Frame: adverse events will be recorded at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6. ]
    Any adverse event following acupuncture was assessed by physicians and patients. Patients were instructed to record any unexpected signs, symptoms, and feelings during the entire trial period.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. history of physician-diagnosed SAR with at least 2 years of typical symptoms
  2. positive skin prick test (SPT) and/or positive serum antigen specific IgE to local seasonal pollens (Giant Ragweed, Mugwort, Goosefoot, etc)

Exclusion Criteria:

  1. oral steroids within 4 weeks prior to recruitment
  2. nasal steroids and/or antihistamine 2 weeks prior to recruitment
  3. perennial AR
  4. any respiratory infection within the previous 4 weeks prior to recruitment
  5. history of nasal polyps, nasal septum deviation, asthma or autoimmune disorders
  6. previously received acupuncture therapy for AR within 1 month prior to recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052945


Contacts
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Contact: Hongfei Lou (8610)58268375 louhongfei@yahoo.com
Contact: Chengshuo Wang (8610)58265801 wangcs830@126.com

Locations
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China, Beijing
Hongfei Lou Recruiting
Beijing, Beijing, China, 100730
Contact: Hongfei Lou, Doctor         
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
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Principal Investigator: Luo Zhang Beijing Tongren Hospital

Publications:
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Responsible Party: Luo Zhang, Vice president, Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT04052945     History of Changes
Other Study ID Numbers: SPA acupuncture for SAR
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luo Zhang, Beijing Tongren Hospital:
Acupuncture
sphenopalatine ganglion
seasonal allergic rhinitis
neuropeptides
inflammatory cytokines
neuro-immune interactions
Additional relevant MeSH terms:
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Ganglion Cysts
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases