Clinical trial NCT04815668: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Aerospace 731 Hospital
First posted: 2021-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤ 75 years;
2. 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;
3. Positive skin prick test to grass and birch pollen or/and serum-specific IgE test;
4. Ability to complete the medical information form and sign a written informed consent.

Exclusion Criteria:

1. History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia; autoimmune disorders, or severe chronic inflammatory diseases;
2. History of nasal rhinopolypus or abnormalities;
3. Intake of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics during the 1 month prior to beginning the study;
4. History of systemically administered corticosteroids within 6 months or specific immunotherapy, allergy desensitization therapy within 1 year before enrollment;
5. Serious uncontrolled blood coagulation disorder, cardiovascular disorder, severe hepatic/renal insufficiency or mental disorder;
6. Pregnancy or planning for pregnancy;
7. Known allergy, or contraindication to rescue medication or related drugs;
8. 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.

Primary outcomes:
measure: The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4
timeFrame: weeks 1-4
Secondary outcomes:
measure: 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
timeFrame: over weeks 5- 8 and the first week following symptoms onset in the second year
measure: 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.
timeFrame: over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
measure: 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.
timeFrame: over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
measure: 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.
timeFrame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
measure: 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.
timeFrame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
measure: 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.
timeFrame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
measure: 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.
timeFrame: At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
measure: The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year.
timeFrame: during weeks 1-4, weeks 5-8 in the first year
measure: The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year.
timeFrame: during weeks 1-4, weeks 5-8 in the first year
Other outcomes:
measure: Participants' expectation about therapeutic benefits from acupuncture
timeFrame: At baseline
measure: The proportion of participants remained blinded to treatment arm in acupuncture and placebo acupuncture groups.
timeFrame: Five minutes after the end of the last treatment in the fourth week,
measure: Incidence of adverse events
timeFrame: during weeks 1-8 in the first year and the first week following symptoms onset in the second year
Locations:
city: Beijing
country: China
facility: No.731 Hospital of China Aerospace Science and Industry Corporation
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Weiming Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: