The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function
- Conditions
- Healthy
- Interventions
- Procedure: active sphenopalatine ganglion acupunctureProcedure: sham sphenopalatine ganglion acupuncture
- Registration Number
- NCT02603588
- Lead Sponsor
- Beijing Tongren Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active acupuncture active sphenopalatine ganglion acupuncture intervention: subjects in the active acupuncture group received active sphenopalatine ganglion acupuncture sham acupuncture sham sphenopalatine ganglion acupuncture intervention: subjects in the sham acupuncture group received sham sphenopalatine ganglion acupuncture
- Primary Outcome Measures
Name Time Method The change of subjective perception nasal ventilation at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture 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.
- Secondary Outcome Measures
Name Time Method The change of exhaled nasal nitric oxide assessed by nitric oxide analyser at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture 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 change of nasal patency assessed by acoustic rhinometry at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³).
The change of substance P in nasal secretions were analysed by Enzyme linked immunosorbent assay at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture 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.
The change of nasal patency assessed by Rhinomanometer at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture Rhinomanometer was used to measure unilateral nasal airway resistance (Pa·cm-³·s-1) and the total nasal airway resistance.
The change of vasoactive intestinal peptide in nasal secretions were analysed by Enzyme linked immunosorbent assay at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture 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.
The change of neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture 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.
Trial Locations
- Locations (1)
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China