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PatientsNCT03282630

The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis

A study testing Sphenopalatine ganglion acupuncture in people with Patients, 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. Investigators aimed to assess the effects of SPG acupuncture in patients with seasonal allergic rhinitis. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Patients
What is being tested?
Sphenopalatine ganglion acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteChina
Study dates
16 Jan 2016to 20 Feb 2017
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients with a history of at least 2 years of seasonal allergic rhinitis
  • no smoking
  • without history of 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.

Who cannot join

  • had received acupuncture within the last four weeks before the study
  • 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: The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial

Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind, controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of 4 week.

Primary trial outcomes are change in symptoms and change in need for medication. The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1, week4 and week 8.

Conditions
Patients
Being tested
Sphenopalatine ganglion acupuncture
Keywords
Acupuncture, Sphenopalatine ganglion, Allergic rhinitis, Randomized Trial
Medical subject headings
Rhinitis, Allergic

What participants receive

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

  • Sphenopalatine ganglion acupunctureProcedure or surgery

    • 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
    • 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.
Study groups in NCT03282630
Study groupRoleWhat they receive
active acupunctureExperimentalProcedure/Surgery: 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.
Receives: Procedure: Sphenopalatine ganglion acupuncture
sham acupunctureSham comparatorProcedure/Surgery: 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.
Receives: Procedure: Sphenopalatine ganglion acupuncture

What is being measured

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

  1. The change of symptoms

    The participants will document the four nasal symptoms (nasal obstruction, rhinorrhea, sneezing, and itching) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a four-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The weekly TNSS will be calculated and compared between the groups.

    Measured: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.

  2. The change of need for medication

    Participants will be asked not to use drugs as much as possible. If drugs are used to relieve symptoms, Medication need will be measured using rescue medication score (RMS), comprising the weekly sum of daily assessments.

    Measured: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.

Secondary outcomes (4)

  1. The change of nasal patency

    Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³) and Rhinomanometer was used to measure the total nasal airway resistance (Pa·cm-³·s-1) .

    Measured: The outcomes will be measured in baseline, week1, week4 and week 8.

  2. The change of exhaled nasal nitric oxide

    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: The outcomes will be measured in baseline, week1, week4 and week 8.

  3. The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions

    The change of substance P, vasoactive intestinal peptide and 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 substance P(pg/ml), vasoactive intestinal peptide (ng/ml) and neuropeptide Y (pg/ml) were analysed.

    Measured: The outcomes will be measured in baseline, week1, week4 and week 8.

  4. The change of inflammatory cytokines in nasal secretions

    The change of inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. 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 inflammatory cytokines (pg/ml) were analysed using the Luminex System.

    Measured: The outcomes will be measured in baseline, week1, week4 and week 8.

Timeline

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

  1. First posted14 Sep 2017
  2. Study start16 Jan 2016
  3. Primary completion16 Jan 2017
  4. Study completion20 Feb 2017

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282630
Sponsor's protocol ID
TR-acupuncture-2
Status last verified
Sep 2017
First submitted
6 Sep 2017
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013 Mar;68(3):365-74. doi: 10.1111/all.12053. Epub 2012 Dec 18.

    PubMed 23253122

  • Xue CC, Zhang AL, Zhang CS, DaCosta C, Story DF, Thien FC. Acupuncture for seasonal allergic rhinitis: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Oct;115(4):317-324.e1. doi: 10.1016/j.anai.2015.05.017. Epub 2015 Jun 11.

    PubMed 26073163

  • Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.

    PubMed 23420231

  • Wang K, Chen L, Wang Y, Wang C, Zhang L. Sphenopalatine Ganglion Acupuncture Improves Nasal Ventilation and Modulates Autonomic Nervous Activity in Healthy Volunteers: A Randomized Controlled Study. Sci Rep. 2016 Jul 18;6:29947. doi: 10.1038/srep29947.

    PubMed 27425415

Questions about this trial

What is this clinical trial studying?

A study testing Sphenopalatine ganglion acupuncture in people with Patients, 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 14 Sep 2017. 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 symptoms (time frame: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.). The study lists 2 primary outcomes in all. 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 NCT03282630, which also lists 4 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 14 Sep 2017.

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