NCT02603588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

November 7, 2015

Last Update Submit

November 10, 2015

Conditions

Healthy

Keywords

AcupunctureSphenopalatine ganglionNasal ventilationNeuropeptides

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The change of exhaled nasal nitric oxide assessed by nitric oxide analyser

    at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture

  • The change of nasal patency assessed by acoustic rhinometry

    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

    at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture

  • The change of nasal patency assessed by Rhinomanometer

    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

    at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture

  • +1 more secondary outcomes

Study Arms (2)

active acupuncture

EXPERIMENTAL

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

Procedure: active sphenopalatine ganglion acupuncture

sham acupuncture

SHAM COMPARATOR

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

Procedure: sham sphenopalatine ganglion acupuncture

Interventions

active sphenopalatine ganglion acupuncturePROCEDURE

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.

active acupuncture
sham sphenopalatine ganglion acupuncturePROCEDURE

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.

sham acupuncture

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (7)

  • Shakeel M, Trinidade A, Ah-See KW. Complementary and alternative medicine use by otolaryngology patients: a paradigm for practitioners in all surgical specialties. Eur Arch Otorhinolaryngol. 2010 Jun;267(6):961-71. doi: 10.1007/s00405-009-1098-1. Epub 2009 Sep 22.

    PMID: 19771443BACKGROUND

  • Pletcher SD, Goldberg AN, Lee J, Acquah J. Use of acupuncture in the treatment of sinus and nasal symptoms: results of a practitioner survey. Am J Rhinol. 2006 Mar-Apr;20(2):235-7.

    PMID: 16686397BACKGROUND

  • Sertel S, Bergmann Z, Ratzlaff K, Baumann I, Greten HJ, Plinkert PK. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study. Am J Rhinol Allergy. 2009 Nov-Dec;23(6):e23-8. doi: 10.2500/ajra.2009.23.3380. Epub 2009 Sep 18.

    PMID: 19769799BACKGROUND

  • Zhang L, Yang W, Wang KJ. [Acupuncture at ganglion pterygoplatinum for 71 cases of chronic simple rhinitis]. Zhongguo Zhen Jiu. 2013 Jun;33(6):495-6. No abstract available. Chinese.

    PMID: 23967633BACKGROUND

  • Baraniuk JN, Merck SJ. Neuroregulation of human nasal mucosa. Ann N Y Acad Sci. 2009 Jul;1170:604-9. doi: 10.1111/j.1749-6632.2009.04481.x.

    PMID: 19686200BACKGROUND

  • Loehrl TA. Autonomic dysfunction, allergy and the upper airway. Curr Opin Otolaryngol Head Neck Surg. 2007 Aug;15(4):264-7. doi: 10.1097/MOO.0b013e32826fbcc9.

    PMID: 17620901BACKGROUND

  • McDonald JL, Cripps AW, Smith PK, Smith CA, Xue CC, Golianu B. The anti-inflammatory effects of acupuncture and their relevance to allergic rhinitis: a narrative review and proposed model. Evid Based Complement Alternat Med. 2013;2013:591796. doi: 10.1155/2013/591796. Epub 2013 Feb 14.

    PMID: 23476696BACKGROUND

Study Officials

  • Luo Zhang

    Beijing Institute of Otolaryngology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Beijing Institute of Otolaryngology.

Study Record Dates

First Submitted

November 7, 2015

First Posted

November 13, 2015

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

CN(1)