The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind, controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of 4 week. Primary trial outcomes are change in symptoms and change in need for medication. The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1, week4 and week 8.

Official Title
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The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial

Conditions
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Patients

Intervention / Treatment
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* Procedure: Sphenopalatine ganglion acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a history of at least 2 years of seasonal allergic rhinitis no smoking without history of nasal polyps, nasal septum deviation and history of nose surgery) or lung disease (asthma, chronic obstructive pulmonary disease and fibrosis) free of upper and lower respiratory tract infections for at least 4 weeks before beginning the study. Exclusion Criteria: had received acupuncture within the last four weeks before the study history of diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active acupuncture<br>Procedure/Surgery: active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process and temporal process. The needle was rotated until the participant felt de-qi sensations. | Procedure: Sphenopalatine ganglion acupuncture<br>* active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.<br>|
| Sham Comparator: sham acupuncture<br>Procedure/Surgery: Sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment. | Procedure: Sphenopalatine ganglion acupuncture<br>* active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of symptoms | The participants will document the four nasal symptoms (nasal obstruction, rhinorrhea, sneezing, and itching) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a four-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The weekly TNSS will be calculated and compared between the groups. | The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. | 
| The change of need for medication | Participants will be asked not to use drugs as much as possible. If drugs are used to relieve symptoms, Medication need will be measured using rescue medication score (RMS), comprising the weekly sum of daily assessments. | The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of nasal patency | Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³) and Rhinomanometer was used to measure the total nasal airway resistance (Pa·cm-³·s-1) . | The outcomes will be measured in baseline, week1, week4 and week 8. | 
| The change of exhaled nasal nitric oxide | The change of exhaled nasal nitric oxide assessed by nitric oxide analyser. A nitric oxide analyser was used to measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s. | The outcomes will be measured in baseline, week1, week4 and week 8. | 
| The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions | The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of substance P(pg/ml), vasoactive intestinal peptide (ng/ml) and neuropeptide Y (pg/ml) were analysed. | The outcomes will be measured in baseline, week1, week4 and week 8. | 
| The change of inflammatory cytokines in nasal secretions | The change of inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of inflammatory cytokines (pg/ml) were analysed using the Luminex System. | The outcomes will be measured in baseline, week1, week4 and week 8. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Sphenopalatine ganglion, Allergic rhinitis, Randomized Trial