The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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active acupuncture

intervention: subjects in the active acupuncture group received active sphenopalatine ganglion acupuncture

Group Type EXPERIMENTAL

active sphenopalatine ganglion acupuncture

Intervention Type PROCEDURE

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.

sham acupuncture

intervention: subjects in the sham acupuncture group received sham sphenopalatine ganglion acupuncture

Group Type SHAM_COMPARATOR

sham sphenopalatine ganglion acupuncture

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes