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

Official title

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

Overview

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.

Interventions

• Other Acupuncture group
  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 wil
• Other Placebo acupuncture group
  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.
• Other Rescue medication group
  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.

Primary outcome measures

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

Secondary outcome measures (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 [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year]
• A global evaluation in comparison to previous years by each participant at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year. [Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year]
• Patient global evaluation of improvement at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year. [Time frame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year]
• The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year. [Time frame: during weeks 1-4, weeks 5-8 in the first year]
• The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year. [Time frame: during weeks 1-4, weeks 5-8 in the first year]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• No.731 Hospital of China Aerospace Science and Industry Corporation — Beijing

Identifiers

NCT: NCT04815668 · 2020YK14

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗