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Trial record 71 of 1180 for:    acupuncture

The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function

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ClinicalTrials.gov Identifier: NCT02603588
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Luo Zhang, Beijing Tongren Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Procedure: active sphenopalatine ganglion acupuncture Procedure: sham sphenopalatine ganglion acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Sphenopalatine Ganglion Acupuncture on Nasal Ventilation and Autonomic Nervous Activity in Healthy Volunteers
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: active acupuncture
intervention: subjects in the active acupuncture group received active 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 and temporal process. The needle was rotated until the participant felt "de-qi" sensations.

Sham Comparator: sham acupuncture
intervention: subjects in the sham acupuncture group received sham sphenopalatine ganglion acupuncture
Procedure: 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 Outcome Measures :
  1. The change of subjective perception nasal ventilation [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    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 :
  1. The change of exhaled nasal nitric oxide assessed by nitric oxide analyser [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    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.

  2. The change of nasal patency assessed by acoustic rhinometry [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³).

  3. The change of substance P in nasal secretions were analysed by Enzyme linked immunosorbent assay [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    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.

  4. The change of nasal patency assessed by Rhinomanometer [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    Rhinomanometer was used to measure unilateral nasal airway resistance (Pa·cm⁻³·s⁻1) and the total nasal airway resistance.

  5. The change of vasoactive intestinal peptide in nasal secretions were analysed by Enzyme linked immunosorbent assay [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    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.

  6. The change of neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay [ Time Frame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603588


Locations
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China, Beijing
Beijing Tongren Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
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Principal Investigator: Luo Zhang Beijing Institute of Otolaryngology

Publications:
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Responsible Party: Luo Zhang, Director, Beijing Institute of Otolaryngology., Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT02603588     History of Changes
Other Study ID Numbers: TR-acupuncture-1
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Luo Zhang, Beijing Tongren Hospital:
Acupuncture
Sphenopalatine ganglion
Nasal ventilation
Neuropeptides

Additional relevant MeSH terms:
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Ganglion Cysts
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases