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HealthyNCT02603588

The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

A study testing active sphenopalatine ganglion acupuncture in people with Healthy, run by Beijing Tongren Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
active sphenopalatine ganglion acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteChina
Study dates
Feb 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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

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.

Conditions
Healthy
Being tested
active sphenopalatine ganglion acupuncture, sham sphenopalatine ganglion acupuncture
Keywords
Acupuncture, Sphenopalatine ganglion, Nasal ventilation, Neuropeptides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active sphenopalatine ganglion acupunctureProcedure or surgery

    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 acupunctureProcedure or surgery

    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.

Study groups in NCT02603588
Study groupRoleWhat they receive
active acupunctureExperimentalintervention: subjects in the active acupuncture group received active sphenopalatine ganglion acupuncture
Receives: Procedure: active sphenopalatine ganglion acupuncture
sham acupunctureSham comparatorintervention: subjects in the sham acupuncture group received sham sphenopalatine ganglion acupuncture
Receives: Procedure: sham sphenopalatine ganglion acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. 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.

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

  2. The change of nasal patency assessed by acoustic rhinometry

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

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionMar 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603588
Sponsor's protocol ID
TR-acupuncture-1
Status last verified
Nov 2015
First submitted
7 Nov 2015
Last updated
13 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19771443

  • 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.

    PubMed 16686397

  • 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.

    PubMed 19769799

  • 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.

    PubMed 23967633

  • 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.

    PubMed 19686200

  • 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.

    PubMed 17620901

  • 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.

    PubMed 23476696

Questions about this trial

What is this clinical trial studying?

A study testing active sphenopalatine ganglion acupuncture in people with Healthy, run by Beijing Tongren Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of subjective perception nasal ventilation (time frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02603588, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.

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