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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
No.731 Hospital of China Aerospace Science and Industry Corporation
RECRUITING
Beijing
Contact Information
Primary
Weiming Wang, MD, PhD
wangweiming1a1@163.com
010-88001830
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Acupuncture group
Placebo_comparator: Placebo acupuncture group
Other: Rescue medication
Sponsors
Leads: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: Aerospace 731 Hospital

This content was sourced from clinicaltrials.gov