Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis

NCT04815668 | Recruiting

• 1 other identifier: 2020YK14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies. The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive. We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4

  The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.

  weeks 1-4

Secondary Outcomes (9)

• The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 5- 8 and the first week following symptoms onset in the second year

  over weeks 5- 8 and the first week following symptoms onset in the second year

• Change in the average daily symptom score (dSS) and daily medication score (dMS) from baseline over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.

  over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.

• The proportion of participants with a minimum of 23% improvement in average daily Combined Symptoms and Medication Score (CSMS) from baseline over weeks 1-4, weeks 5-8 in the first year and at the first week following symptoms onset in the second year.

  over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.

• Change in the Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ) total score and subscale scores from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.

  At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year

• Change in the Visual analog scale score for the overall allergic symptoms severity from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.

  At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year

Other Outcomes (3)

• Participants' expectation about therapeutic benefits from acupuncture

  At baseline

• The proportion of participants remained blinded to treatment arm in acupuncture and placebo acupuncture groups.

  Five minutes after the end of the last treatment in the fourth week,

• Incidence of adverse events

  during weeks 1-8 in the first year and the first week following symptoms onset in the second year

Study Arms (3)

Acupuncture group

EXPERIMENTAL

Other: Acupuncture group

Placebo acupuncture group

PLACEBO COMPARATOR

Other: Placebo acupuncture group

Rescue medication

OTHER

Other: Rescue medication group

Interventions

Acupuncture group OTHER

Sterile single-use stainless steel needles (size 0.35 mm × 55 mm) (YiDaiFu brand, Suzhou Tianyi Acupuncture Instrument Co., Ltd., Suzhou, China) will be utilized. Participants in lateral position, the acupoints area will be sterilized with 75% alcohol. To stimulate SPG, the needles will be inserted in the medial superior anterior direction to a depth of approximately 55 mm33 until the participants report a special sensation radiating toward the nose or the upper teeth. After that, the needle will be withdrew slightly. The needles will be retained for 30 minutes after three stimulation. Rescue medication are permitted when participants feel that their symptoms are intolerable.

Acupuncture group

Placebo acupuncture group OTHER

The acupuncture procedure will be similar to that of the acupuncture group. After sterilizing the skin, the 0.35 × 25 mm disposable needle will be vertically inserted at SPG acupoint about 3-5 mm. No needle manipulation will be conducted to avoid the deqi response. Rescue medication are permitted when participants feel that their symptoms are intolerable.

Placebo acupuncture group

Rescue medication group OTHER

Participants in the rescue medication group do not receive acupuncture treatment during the study period. They will be only allowed to use rescue medication. They have the option of 4 weeks (up to 8 sessions) of acupuncture free of charge at the end of the follow-up period.

Rescue medication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤ 75 years;
• History of moderate to severe SAR symptoms (Visual analog scale(VAS) \>50 mm, range, 0 cm\[not at all bothersome\] to 100 mm\[extremely bothersome\]) for more than 4 days/weeks, and more than 4 consecutive weeks with at least two years' duration;
• Positive skin prick test to grass and birch pollen or/and serum-specific IgE test;
• Ability to complete the medical information form and sign a written informed consent.

You may not qualify if:

• History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia; autoimmune disorders, or severe chronic inflammatory diseases;
• History of nasal rhinopolypus or abnormalities;
• Intake of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics during the 1 month prior to beginning the study;
• History of systemically administered corticosteroids within 6 months or specific immunotherapy, allergy desensitization therapy within 1 year before enrollment;
• Serious uncontrolled blood coagulation disorder, cardiovascular disorder, severe hepatic/renal insufficiency or mental disorder;
• Pregnancy or planning for pregnancy;
• Known allergy, or contraindication to rescue medication or related drugs;
• Known phobia to acupuncture or having received acupuncture treatment, or sphenopalatine ganglion stimulation or other complementary and alternative medicine within 1 months prior to enrollment.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Aerospace 731 Hospital: collaborator

Study Sites (1)

No.731 Hospital of China Aerospace Science and Industry Corporation

Beijing, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Weiming Wang, MD,PhD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Wang, MD, PhD

CONTACT

010-88001830; wangweiming1a1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the participants in acupuncture group and SA group, outcome evaluators and statistician in the two acupuncture groups will be blinded to the group allocation throughout the entire trial. Participants in the rescue medication group and acupuncturists will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants who agreed to randomization will be allocated to the acupuncture group, sham acupuncture group or rescue medication group in a 1:1:1 ratio

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)