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Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis

Primary Purpose

Seasonal Allergic Rhinitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture group
Placebo acupuncture group
Rescue medication group
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years and ≤ 75 years;
  2. History of moderate to severe SAR symptoms (Visual analog scale(VAS) >50 mm, range, 0 cm[not at all bothersome] to 100 mm[extremely bothersome]) for more than 4 days/weeks, and more than 4 consecutive weeks with at least two years' duration;
  3. Positive skin prick test to grass and birch pollen or/and serum-specific IgE test;
  4. Ability to complete the medical information form and sign a written informed consent.

Exclusion Criteria:

  1. History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia; autoimmune disorders, or severe chronic inflammatory diseases;
  2. History of nasal rhinopolypus or abnormalities;
  3. Intake of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics during the 1 month prior to beginning the study;
  4. History of systemically administered corticosteroids within 6 months or specific immunotherapy, allergy desensitization therapy within 1 year before enrollment;
  5. Serious uncontrolled blood coagulation disorder, cardiovascular disorder, severe hepatic/renal insufficiency or mental disorder;
  6. Pregnancy or planning for pregnancy;
  7. Known allergy, or contraindication to rescue medication or related drugs;
  8. Known phobia to acupuncture or having received acupuncture treatment, or sphenopalatine ganglion stimulation or other complementary and alternative medicine within 1 months prior to enrollment.

Sites / Locations

  • No.731 Hospital of China Aerospace Science and Industry CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Acupuncture group

Placebo acupuncture group

Rescue medication

Arm Description

Outcomes

Primary Outcome Measures

The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.

Secondary Outcome Measures

The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 5- 8 and the first week following symptoms onset in the second year
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Change in the average daily symptom score (dSS) and daily medication score (dMS) from baseline over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
The daily symptom score (dSS) contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The daily medication score (dMS) will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
The proportion of participants with a minimum of 23% improvement in average daily Combined Symptoms and Medication Score (CSMS) from baseline over weeks 1-4, weeks 5-8 in the first year and at the first week following symptoms onset in the second year.
A difference of 23% on the average daily Combined Symptoms and Medication Score (CSMS) was chosen to demonstrate a minimum clinically important difference.
Change in the Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ) total score and subscale scores from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
The RQLQ is a well-established and validated questionnaire consisted of 28 questions covering 7 domains: sleep (3 items), practical problems (3 items), non-nasal and eye symptoms (7 items), nasal symptoms (4 items), eye symptoms (4 items), activities that have been limited by nose or eye symptoms (3 items), and emotional function (4 items). Each item will be evaluated on a 7-point rating scale ranging from 0 (no impairment) to 6 (severe impairment) during the previous week.
Change in the Visual analog scale score for the overall allergic symptoms severity from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Patients will be asked to grade the severity of allergic symptoms using the self-rated 0-100mm Visual analog scale (0, no symptoms, to 100, worst-ever symptoms, in 1-point increment).
A global evaluation in comparison to previous years by each participant at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Each participant will be asked the following question: ''Compared to your symptoms in previous grass pollen seasons, how have you felt overall in this grass pollen season? (Tick only one)". The possible answers are coded as follows:1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse".
Patient global evaluation of improvement at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Patient global evaluation of improvement will be rated by the participants using a 7-point Likert scale with the following options: 1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse" at each study visit.
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year.
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year.
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups

Full Information

First Posted
March 23, 2021
Last Updated
September 12, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Aerospace 731 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04815668
Brief Title
Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis
Official Title
Effect of Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Aerospace 731 Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies. The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive. We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants who agreed to randomization will be allocated to the acupuncture group, sham acupuncture group or rescue medication group in a 1:1:1 ratio
Masking
InvestigatorOutcomes Assessor
Masking Description
the participants in acupuncture group and SA group, outcome evaluators and statistician in the two acupuncture groups will be blinded to the group allocation throughout the entire trial. Participants in the rescue medication group and acupuncturists will not be blinded.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Title
Placebo acupuncture group
Arm Type
Placebo Comparator
Arm Title
Rescue medication
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Acupuncture group
Intervention Description
Sterile single-use stainless steel needles (size 0.35 mm × 55 mm) (YiDaiFu brand, Suzhou Tianyi Acupuncture Instrument Co., Ltd., Suzhou, China) will be utilized. Participants in lateral position, the acupoints area will be sterilized with 75% alcohol. To stimulate SPG, the needles will be inserted in the medial superior anterior direction to a depth of approximately 55 mm33 until the participants report a special sensation radiating toward the nose or the upper teeth. After that, the needle will be withdrew slightly. The needles will be retained for 30 minutes after three stimulation. Rescue medication are permitted when participants feel that their symptoms are intolerable.
Intervention Type
Other
Intervention Name(s)
Placebo acupuncture group
Intervention Description
The acupuncture procedure will be similar to that of the acupuncture group. After sterilizing the skin, the 0.35 × 25 mm disposable needle will be vertically inserted at SPG acupoint about 3-5 mm. No needle manipulation will be conducted to avoid the deqi response. Rescue medication are permitted when participants feel that their symptoms are intolerable.
Intervention Type
Other
Intervention Name(s)
Rescue medication group
Intervention Description
Participants in the rescue medication group do not receive acupuncture treatment during the study period. They will be only allowed to use rescue medication. They have the option of 4 weeks (up to 8 sessions) of acupuncture free of charge at the end of the follow-up period.
Primary Outcome Measure Information:
Title
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 1- 4
Description
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Time Frame
weeks 1-4
Secondary Outcome Measure Information:
Title
The change from baseline in the average daily Combined Symptoms and Medication Score (CSMS) over weeks 5- 8 and the first week following symptoms onset in the second year
Description
The average daily Combined Symptoms and Medication Score (CSMS) is the sum of the daily symptom score (dSS) plus daily medication score (dMS) . The dSS contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The dMS will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Time Frame
over weeks 5- 8 and the first week following symptoms onset in the second year
Title
Change in the average daily symptom score (dSS) and daily medication score (dMS) from baseline over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
Description
The daily symptom score (dSS) contains a 6-item scale referring to nasal symptoms (4 items) and ocular symptoms (2 items), with each item scored using a Likert scale of 0 to 3. The dSS will be calculated as a mean of all non-missing dSS divided by the number of individual symptoms (range, o to 3). The daily medication score (dMS) will again be calculated as an average of daily symptom relief medication score, with a range of 0 to 3.
Time Frame
over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
Title
The proportion of participants with a minimum of 23% improvement in average daily Combined Symptoms and Medication Score (CSMS) from baseline over weeks 1-4, weeks 5-8 in the first year and at the first week following symptoms onset in the second year.
Description
A difference of 23% on the average daily Combined Symptoms and Medication Score (CSMS) was chosen to demonstrate a minimum clinically important difference.
Time Frame
over weeks 1- 4, weeks 5-8 in the first year and the first week following symptoms onset in the second year.
Title
Change in the Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ) total score and subscale scores from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Description
The RQLQ is a well-established and validated questionnaire consisted of 28 questions covering 7 domains: sleep (3 items), practical problems (3 items), non-nasal and eye symptoms (7 items), nasal symptoms (4 items), eye symptoms (4 items), activities that have been limited by nose or eye symptoms (3 items), and emotional function (4 items). Each item will be evaluated on a 7-point rating scale ranging from 0 (no impairment) to 6 (severe impairment) during the previous week.
Time Frame
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Title
Change in the Visual analog scale score for the overall allergic symptoms severity from baseline to the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Description
Patients will be asked to grade the severity of allergic symptoms using the self-rated 0-100mm Visual analog scale (0, no symptoms, to 100, worst-ever symptoms, in 1-point increment).
Time Frame
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Title
A global evaluation in comparison to previous years by each participant at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Description
Each participant will be asked the following question: ''Compared to your symptoms in previous grass pollen seasons, how have you felt overall in this grass pollen season? (Tick only one)". The possible answers are coded as follows:1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse".
Time Frame
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Title
Patient global evaluation of improvement at the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year.
Description
Patient global evaluation of improvement will be rated by the participants using a 7-point Likert scale with the following options: 1, "Very much better"; 2, "Much better"; 3, "A little better"; 4, "No change"; 5, "A little worse"; 6, "Much worse"; and 7, "Very much worse" at each study visit.
Time Frame
At the end of weeks 4 and 8 in the first year and the first week following symptoms onset in the second year
Title
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year.
Description
The average weekly number of medication-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups
Time Frame
during weeks 1-4, weeks 5-8 in the first year
Title
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year.
Description
The average weekly number of symptom-free days during weeks 1-4, weeks 5-8 in the first year will be compared among three groups
Time Frame
during weeks 1-4, weeks 5-8 in the first year
Other Pre-specified Outcome Measures:
Title
Participants' expectation about therapeutic benefits from acupuncture
Description
Participants in the acupuncture and placebo acupuncture groups will be asked the following question: "How helpful you believe the acupuncture modality you received would be for your allergic rhinitis?"
Time Frame
At baseline
Title
The proportion of participants remained blinded to treatment arm in acupuncture and placebo acupuncture groups.
Description
Each participant in the acupuncture and placebo acupuncture groups will be asked the following question: "Which treatment do you think you have received (acupuncture or placebo acupuncture)?"
Time Frame
Five minutes after the end of the last treatment in the fourth week,
Title
Incidence of adverse events
Description
Any potential adverse events (AEs) will be monitored and documented in the CRFs within 24 hours after their occurrence during the treatment and follow-up period. According to their potential association with acupuncture, AEs will be categorized as acupuncture-associated AEs (e.g., subcutaneous hemorrhage, dizziness, fainting, serious pain, and local infection fainting, localized hematoma), and non-treatment-related AEs.
Time Frame
during weeks 1-8 in the first year and the first week following symptoms onset in the second year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years and ≤ 75 years; History of moderate to severe SAR symptoms (Visual analog scale(VAS) >50 mm, range, 0 cm[not at all bothersome] to 100 mm[extremely bothersome]) for more than 4 days/weeks, and more than 4 consecutive weeks with at least two years' duration; Positive skin prick test to grass and birch pollen or/and serum-specific IgE test; Ability to complete the medical information form and sign a written informed consent. Exclusion Criteria: History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia; autoimmune disorders, or severe chronic inflammatory diseases; History of nasal rhinopolypus or abnormalities; Intake of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics during the 1 month prior to beginning the study; History of systemically administered corticosteroids within 6 months or specific immunotherapy, allergy desensitization therapy within 1 year before enrollment; Serious uncontrolled blood coagulation disorder, cardiovascular disorder, severe hepatic/renal insufficiency or mental disorder; Pregnancy or planning for pregnancy; Known allergy, or contraindication to rescue medication or related drugs; Known phobia to acupuncture or having received acupuncture treatment, or sphenopalatine ganglion stimulation or other complementary and alternative medicine within 1 months prior to enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiming Wang, MD, PhD
Phone
010-88001830
Email
wangweiming1a1@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiming Wang, MD,PhD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.731 Hospital of China Aerospace Science and Industry Corporation
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Chen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis

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