search
Back to results

The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active sphenopalatine ganglion acupuncture
sham sphenopalatine ganglion acupuncture
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Acupuncture, Sphenopalatine ganglion, Nasal ventilation, Neuropeptides

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active acupuncture

sham acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The change of nasal patency assessed by acoustic rhinometry
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
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
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
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
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.

Full Information

First Posted
November 7, 2015
Last Updated
November 10, 2015
Sponsor
Beijing Tongren Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02603588
Brief Title
The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function
Official Title
Effects of Sphenopalatine Ganglion Acupuncture on Nasal Ventilation and Autonomic Nervous Activity in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Acupuncture, Sphenopalatine ganglion, Nasal ventilation, Neuropeptides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active acupuncture
Arm Type
Experimental
Arm Description
intervention: subjects in the active acupuncture group received active sphenopalatine ganglion acupuncture
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
intervention: subjects in the sham acupuncture group received sham sphenopalatine ganglion acupuncture
Intervention Type
Procedure
Intervention Name(s)
active sphenopalatine ganglion acupuncture
Intervention Description
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
Intervention Name(s)
sham sphenopalatine ganglion acupuncture
Intervention Description
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 Outcome Measure Information:
Title
The change of subjective perception nasal ventilation
Description
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.
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Secondary Outcome Measure Information:
Title
The change of exhaled nasal nitric oxide assessed by nitric oxide analyser
Description
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.
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Title
The change of nasal patency assessed by acoustic rhinometry
Description
Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³).
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Title
The change of substance P in nasal secretions were analysed by Enzyme linked immunosorbent assay
Description
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.
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Title
The change of nasal patency assessed by Rhinomanometer
Description
Rhinomanometer was used to measure unilateral nasal airway resistance (Pa·cm-³·s-1) and the total nasal airway resistance.
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Title
The change of vasoactive intestinal peptide in nasal secretions were analysed by Enzyme linked immunosorbent assay
Description
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.
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Title
The change of neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay
Description
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.
Time Frame
at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Organizational Affiliation
Beijing Institute of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19771443
Citation
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.
Results Reference
background
PubMed Identifier
16686397
Citation
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.
Results Reference
background
PubMed Identifier
19769799
Citation
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.
Results Reference
background
PubMed Identifier
23967633
Citation
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.
Results Reference
background
PubMed Identifier
19686200
Citation
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.
Results Reference
background
PubMed Identifier
17620901
Citation
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.
Results Reference
background
PubMed Identifier
23476696
Citation
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.
Results Reference
background

Learn more about this trial

The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

We'll reach out to this number within 24 hrs