Skip to main content
OpenTrials
Completed

NCT Number: NCT03282630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 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: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • had received acupuncture within the last four weeks before the study
  • history of diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.

Treatment and study plan

Sphenopalatine ganglion acupuncture

Procedure
  • 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.

Primary outcomes

  1. The change of symptoms

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

    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.

  2. The change of need for medication

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

    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.

Secondary outcomes

  1. The change of nasal patency

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

    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) .

  2. The change of exhaled nasal nitric oxide

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

    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.

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

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

    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.

  4. The change of inflammatory cytokines in nasal secretions

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

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 14, 2017
Registry last updated
Sep 14, 2017

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.

Published trials that share one or more normalized conditions with this study.