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Completed

NCT Number: NCT02603588

The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

active sphenopalatine ganglion acupuncture

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 sphenopalatine ganglion acupuncture

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.

Primary outcomes

  1. The change of subjective perception nasal ventilation

    Time frame: 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 outcomes

  1. The change of exhaled nasal nitric oxide assessed by nitric oxide analyser

    Time frame: 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.

  2. The change of nasal patency assessed by acoustic rhinometry

    Time frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture

    Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³).

  3. The change of substance P in nasal secretions were analysed by Enzyme linked immunosorbent assay

    Time frame: 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.

  4. The change of nasal patency assessed by Rhinomanometer

    Time frame: 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.

  5. The change of vasoactive intestinal peptide in nasal secretions were analysed by Enzyme linked immunosorbent assay

    Time frame: 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.

  6. The change of neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2015
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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