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| ID | Type | Description | Link |
|---|---|---|---|
| 2023YFC2507905 | Other Grant/Funding Number | National Key Research and Development Program of China |
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The present study was a randomised, parallel controlled, open-label, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the conventional drug treatment group (group B). Patients with idiopathic rhinitis (IR) who met the inclusion criteria were included in a 7-day introductory period of nasal spray hormone (Budesonide nasal spray) treatment. Subjects with IR who met the randomization criteria after the introductory period were randomized 1:1 to either group A or group B for a 1-year treatment follow-up study. In group A, subjects will undergo the posterior nasal nerve combined with anterior ethmoid neurotomy. In group B, subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines (Loratadine) or nasal antihistamines (Azelastine Hydrochloride) are preferred, and nasal hormones (Budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases. Participants will be evaluated for safety and efficacy throughout the entire three-year period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior nasal nerve combined with anterior ethmoid neurotomy group | Experimental | Subjects will undergo posterior nasal nerve combined with anterior ethmoid neurotomy under nasal endoscope. |
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| Drug therapy group | Active Comparator | Subjects will be treated with medication according to guideline recommendations when nasal symptoms such as nasal obstruction, rhinorrhea, itching, and sneezing occur. Oral antihistamines (Loratadine) or nasal antihistamines (Azelastine) are preferred, and nasal hormones (Budesonide), or a combination of two or three drugs, may be used in severe cases. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior nasal nerve combined with anterior ethmoid neurotomy | Procedure | First, a vertical incision was made in the posterior portion of the middle nasal turbinate. Dissection was performed along the bone to elevate the mucosal flap to expose the thick orbital process of the vertical plate of the palatine bone and the sphenopalatine foramen. The 3-4 mm of mucosal and submucosal neurovascular bundles surrounding the sphenopalatine foramen were subjected to full radiofrequency ablation, directly to the bone. The mucoperiosteal flap is reposited back. The bilateral nasal cavity was packed with Merocel nasal pack and hemostasis was achieved. The anterior ethmoidal nerves of the lateral nasal branch and septal branch of the nasal cavity were cut off with a plasma treatment needle. Below 30°, the mucous membrane of the posterior lateral wall of the nasal colliculus was cut down to the bone surface using the needle of the nasal endoscope plasma therapy instrument. The contralateral side was then treated in the same way, with an arc cut line and a length of 2cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined symptom and medication score (CSMS) | The combined symptom and medication score (CSMS) is a validated composite metric widely used in clinical research and practice to holistically assess the severity and control of rhinitis. It integrates both subjective symptom burden and objective medication use into a single quantitative score.A questionnaire was used to evaluate the CSMS. | 3rd postoperative months |
| Measure | Description | Time Frame |
|---|---|---|
| Combined symptom and medication score (CSMS) | The combined symptom and medication score (CSMS) is a validated composite metric widely used in clinical research and practice to holistically assess the severity and control of rhinitis. It integrates both subjective symptom burden and objective medication use into a single quantitative score.A questionnaire was used to evaluate the CSMS. | 6th and 12th postoperative months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Xu | Contact | +8615927088198 | xuy@whu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36246705 | Background | Wu R, Dong L, Mao H, Wang J, Ma D, Sun J. Clinical study on the treatment of moderate to severe persistent allergic rhinitis by posterior nasal nerve combined with anterior ethmoid neurotomy. Pak J Med Sci. 2022 Sep-Oct;38(7):1888-1892. doi: 10.12669/pjms.38.7.5561. | |
| 36066203 | Background | Balai E, Gupta KK, Jolly K, Darr A. Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis. Eur Ann Allergy Clin Immunol. 2023 May;55(3):101-114. doi: 10.23822/EurAnnACI.1764-1489.268. Epub 2022 Sep 6. |
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| Drug therapy group | Drug | Subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines or nasal antihistamines are preferred, and nasal hormones (budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases. |
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| Total nasal symptoms score (TNSS) | The total nasal symptoms score (TNSS) is a patient-reported outcome tool widely utilized to quantify the severity of nasal symptoms in allergic rhinitis (AR) and other rhinologic conditions. It provides a standardized, composite assessment of key nasal symptoms including nasal congestion, rhinorrhea, sneezing, and nasal itching. A questionnaire was used to evaluate the TNSS. | 3rd, 6th, and 12th postoperative months |
| Rhinoconjunctivitis quality of life questionnaire (RQLQ) | The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a validated, patient-reported outcome measure specifically designed to assess the impact of rhinoconjunctivitis on patients' daily functioning and overall well-being. It incluges 28 items grouped into 7 domains: nasal symptoms, ocular symptoms, practical problems, activity limitations, emotional impact, sleep disturbances, general health perceptions. | 3rd, 6th, and 12th postoperative months |
| Rhinitis Control Assessment Test (RCAT) | The RCAT is a patient-reported assessment tool designed to evaluate the level of control over rhinitis symptoms, assisting clinicians in evaluating treatment efficacy and adjusting management strategies.It typically consists of six items assessing the frequency of symptoms (such as nasal congestion, rhinorrhea, and sneezing) and their impact on daily life over the past week. For the RCAT, an internationally recognized questionnaire was used for measurement. | 3rd, 6th, and 12th postoperative months |
| Substance P(SP)、Vasoactive Intestinal Peptide(VIP)、Calcitonin Gene-Related Peptide(CGRP)、Neuropeptide Y(NPY) | Neuropeptide substance P (SP), vasoactive intestinal peptide (VIP), calcitonin gene-related peptide (CGRP) and neuropeptide Y (NPY) were measured in nasal secretions using ELISA. | 3rd, 6th, and 12th postoperative months |
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
| 38467330 | Background | Baroody FM, Gevaert P, Smith PK, Ziaie N, Bernstein JA. Nonallergic Rhinopathy: A Comprehensive Review of Classification, Diagnosis, and Treatment. J Allergy Clin Immunol Pract. 2024 Jun;12(6):1436-1447. doi: 10.1016/j.jaip.2024.03.009. Epub 2024 Mar 11. |
| 28474799 | Background | Hellings PW, Klimek L, Cingi C, Agache I, Akdis C, Bachert C, Bousquet J, Demoly P, Gevaert P, Hox V, Hupin C, Kalogjera L, Manole F, Mosges R, Mullol J, Muluk NB, Muraro A, Papadopoulos N, Pawankar R, Rondon C, Rundenko M, Seys SF, Toskala E, Van Gerven L, Zhang L, Zhang N, Fokkens WJ. Non-allergic rhinitis: Position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2017 Nov;72(11):1657-1665. doi: 10.1111/all.13200. Epub 2017 Jun 2. |
| 27083104 | Background | Lieberman PL, Smith P. Nonallergic Rhinitis: Treatment. Immunol Allergy Clin North Am. 2016 May;36(2):305-19. doi: 10.1016/j.iac.2015.12.007. Epub 2016 Feb 26. |