The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

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, but the mechanisms remain largely unknown. Investigators aimed to assess the effects of SPG acupuncture for nasal ventilation function and autonomic nervous system in health volunteers. The randomized, double-blind, controlled clinical trial enrolled healthy volunteers.Healthy subjects were randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All subjects were assessed for self-reported nasal ventilation, nasal patency (nasal airway resistance (NAR) and nasal cavity volume (NVC)), exhaled nasal nitric oxide (nNO) before and after acupuncture. Meanwhile, in order to explore underlying mechanisms of SPG acupuncture, the changes in neuropeptides (substance P (SP), vasoactive intestinal peptide (VIP) and neuropeptide Y (NPY)) in nasal secretions were investigated at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture.

Official Title
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Effects of Sphenopalatine Ganglion Acupuncture on Nasal Ventilation and Autonomic Nervous Activity in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Procedure: active sphenopalatine ganglion acupuncture
* Procedure: sham sphenopalatine ganglion acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-smoking volunteers without history of nasal disease (allergic rhinitis, sinusitis, 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. negative skin prick test for allergy Exclusion Criteria: had received acupuncture within the last four weeks before the start of the study no 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: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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>intervention: subjects in the active acupuncture group received active sphenopalatine ganglion acupuncture | Procedure: active sphenopalatine ganglion acupuncture<br>* 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.<br>|
| Sham Comparator: sham acupuncture<br>intervention: subjects in the sham acupuncture group received sham sphenopalatine ganglion acupuncture | Procedure: sham sphenopalatine ganglion acupuncture<br>* 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 subjective perception nasal ventilation | The subjective perception of nasal ventilation was self-assessed by participants according to three categories: unchanged, better, and worse. Number of participants reported unchanged or better was analysed. | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 
| The change of nasal patency assessed by acoustic rhinometry | Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³). | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 
| The change of substance P 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) were analysed. | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 
| The change of nasal patency assessed by Rhinomanometer | Rhinomanometer was used to measure unilateral nasal airway resistance (Pa·cm-³·s-1) and the total nasal airway resistance. | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 
| The change of vasoactive intestinal peptide 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 vasoactive intestinal peptide (ng/ml) were analysed. | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 
| The change of 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 neuropeptide Y (pg/ml) were analysed. | at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Sphenopalatine ganglion, Nasal ventilation, Neuropeptides