Seasonal Allergic RhinitisNCT04052945
Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis
A study testing SPA acupuncture in people with Seasonal Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- SPA acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2020to 31 Dec 2022
- 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
- history of physician-diagnosed SAR with at least 2 years of typical symptoms, and TNSS>=6 at v0.
- positive skin prick test (SPT) and/or positive serum antigen specific IgE to local seasonal pollens (Giant Ragweed, Mugwort, Goosefoot, etc)
Who cannot join
- oral steroids within 4 weeks prior to recruitment
- nasal steroids and/or antihistamine 2 weeks prior to recruitment
- perennial AR
- any respiratory infection within the previous 4 weeks prior to recruitment
- history of nasal polyps, asthma or autoimmune disorders
- previously received acupuncture therapy for AR within 1 month prior to recruitment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hongfei Lou
Beijing, Beijing Municipality, 100730
Hongfei Lou, Doctor
About this study
Official title: Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo Controlled Study
In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.
In conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.
The investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in pollen-induced seasonal AR patients and to explore the potential underlying mechanisms.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- SPA acupuncture, sham acupuncture
- Keywords
- Acupuncture, sphenopalatine ganglion, seasonal allergic rhinitis, neuropeptides, inflammatory cytokines, neuro-immune interactions
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPA acupunctureProcedure or surgery
For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt "de-qi" sensations .
The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4) within first two weeks, and then followed-up for a further 2 weeks (visit 5 and visit 6 ).
sham acupunctureProcedure or surgery
For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle.
The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4) with first two weeks, and then followed-up for a further 2 weeks (visit 5 and visit 6).
| Study group | Role | What they receive |
|---|---|---|
| SPA acupuncture | Active comparator | active SPG acupuncture plus rescue medication (AA group) Receives: Procedure: SPA acupuncture |
| sham acupuncture | Sham comparator | sham-SPG acupuncture plus rescue medication (SA group) Receives: Procedure: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline symptom scores at visit 4
Patients recorded nasal and ocular symptom severity during the trial. Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were individually graded on a ten-point scale (0, no symptoms; 1-3, mild symptoms; 4-7, moderate symptoms; 8-10, severe symptoms). Our primary outcome is TNSS change from baseline at the end of four-acupuncture treatment at Visit 4 (15 minutes after the fourth acupuncture ). The investigator will compare the symptom scores between the active acupuncture group and the sham acupuncture group.
Measured: Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is within 15 minutes after the fourth acupuncture.
Secondary outcomes (6)
Rescue medication score
when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication. The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)
Measured: RMS will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks after the fourth acupuncture. There is no acupuncture during both V5 and V6
SNOT-22
SNOT-22 is assessed to evaluate the quality of life of the SAR patients.
Measured: SNOT-22 will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks later. There is no acupuncture during both V5 and V6.
nasal patency
Eccovision acoustic rhinometry (Hood Labs, Pembroke, USA) was used to measure the total nasal cavity volume (NCV) and minimum cross-sectional area (MCA). The ATMO 300 Rhinomanometer (ATMOS MedizinTechnikGmbH\&Co., Feldkirch, Germany) was used to measure the nasal airway resistance (NAR) by anterior active rhinomanometry.
Measured: NCV, NAR and MCA will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks after the fourth acupuncture.
neuropeptides in nasal secretions
The levels of neuropeptides; including substance P, vasoactive intestinal peptide (VIP) , neuropeptide Y (NPY)) will be analysed using ELISA.
Measured: Nasal secretions can be obtained at each visit. V1 to V4 is within two weeks. V5 is one week later and V6 is two weeks later. There is no acupuncture during both V5 and V6.
inflammatory cytokines in nasal secretions
The levels of inflammatory cytokines; including interferon-γ (IFN-γ), tumor necrosis factor-α(TNF-α), interleukin (IL)-5, IL-8, IL-17A, and eotaxin in the supernatants will be analyzed using the Luminex System.
Measured: Nasal secretions can be obtained at each visit. V1 to V4 is within two weeks. V5 is one week later and V6 is two weeks later. There is no acupuncture during both V5 and V6.
adverse events
Any adverse event following acupuncture was assessed by physicians and patients. Patients were instructed to record any unexpected signs, symptoms, and feelings during the entire trial period. the pain score will be recorded during V1-V4.
Measured: adverse events will be recorded at V1 to V4. V1, V2, V3, and V4 is within two weeks. V5 is one week after fourth treatment and V6 is two weeks later. There is no acupuncture during both V5 and V6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start25 Mar 2020
- Primary completion31 Oct 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Zhang, Beijing Tongren Hospital
- Investigators
- Luo Zhang, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052945
- Sponsor's protocol ID
- SPA acupuncture for SAR
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 23253122Xue 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 26073163Wang 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 27425415Brinkhaus 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04052945
- Acronym / sponsor ID
- SPA acupuncture for SAR
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Acupuncture, sphenopalatine ganglion, seasonal allergic rhinitis, neuropeptides, inflammatory cytokines, neuro-immune interactions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.
In conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.
The investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in pollen-induced seasonal AR patients and to explore the potential underlying mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPA acupuncture | Active comparator | Procedure: SPA acupunctureactive SPG acupuncture plus rescue medication (AA group) |
| sham acupuncture | Sham comparator | Procedure: sham acupuncturesham-SPG acupuncture plus rescue medication (SA group) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- history of physician-diagnosed SAR with at least 2 years of typical symptoms, and TNSS>=6 at v0.
- positive skin prick test (SPT) and/or positive serum antigen specific IgE to local seasonal pollens (Giant Ragweed, Mugwort, Goosefoot, etc)
Key exclusion criteria (6 listed)
- oral steroids within 4 weeks prior to recruitment
- nasal steroids and/or antihistamine 2 weeks prior to recruitment
- perennial AR
- any respiratory infection within the previous 4 weeks prior to recruitment
- history of nasal polyps, asthma or autoimmune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPA acupunctureFor patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt "de-qi" sensations . The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4) within first two weeks, and then followed-up for a further 2 weeks (visit 5 and visit 6 ). | Procedure or surgery | SPA acupuncture |
| sham acupunctureFor patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle. The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4) with first two weeks, and then followed-up for a further 2 weeks (visit 5 and visit 6). | Procedure or surgery | sham acupuncture |
Primary outcome
Change from baseline symptom scores at visit 4
Time frame: Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is within 15 minutes after the fourth acupuncture.
Patients recorded nasal and ocular symptom severity during the trial. Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were individually graded on a ten-point scale (0, no symptoms; 1-3, mild symptoms; 4-7, moderate symptoms; 8-10, severe symptoms). Our primary outcome is TNSS change from baseline at the end of four-acupuncture treatment at Visit 4 (15 minutes after the fourth acupuncture ). The investigator will compare the symptom scores between the active acupuncture group and the sham acupuncture group.
6 secondary outcomes
Rescue medication score
Time frame: RMS will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks after the fourth acupuncture. There is no acupuncture during both V5 and V6
SNOT-22
Time frame: SNOT-22 will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks later. There is no acupuncture during both V5 and V6.
nasal patency
Time frame: NCV, NAR and MCA will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks after the fourth acupuncture.
neuropeptides in nasal secretions
Time frame: Nasal secretions can be obtained at each visit. V1 to V4 is within two weeks. V5 is one week later and V6 is two weeks later. There is no acupuncture during both V5 and V6.
inflammatory cytokines in nasal secretions
Time frame: Nasal secretions can be obtained at each visit. V1 to V4 is within two weeks. V5 is one week later and V6 is two weeks later. There is no acupuncture during both V5 and V6.
adverse events
Time frame: adverse events will be recorded at V1 to V4. V1, V2, V3, and V4 is within two weeks. V5 is one week after fourth treatment and V6 is two weeks later. There is no acupuncture during both V5 and V6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 23253122Choi 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.
- Background: PubMed 26073163Xue 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.
- Background: PubMed 27425415Wang 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.
- Background: PubMed 23420231Brinkhaus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luo Zhang principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPA acupuncture in people with Seasonal Allergic Rhinitis, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongfei Lou ((8610)58268375, louhongfei@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline symptom scores at visit 4 (time frame: Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is within 15 minutes after the fourth 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 NCT04052945, 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 22 Aug 2022.