Patients with chronic rhinosinusitis without nasal polyps and without indication for surgical intervention Rhinosinusitis Acupuncture
Conditions
Interventions
Participants in the experimental group will receive thread embedding acupuncture in addition to conventional treatment for chronic rhinosinusitis. Absorbable threads will be embedded at selected acupo
Experimental Procedure/Surgery,Placebo Comparator Procedure/Surgery
Thread embedding acupuncture,Sham thread embedding acupuncture
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with chronic rhinosinusitis (CRS) according to the EPOS 2020 diagnostic criteria, with symptoms lasting for at least 12 weeks, confirmed by nasal endoscopy. 2. Willing and able to participate, having provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of nasal polyps detected on nasal endoscopy. 2. Indication for surgical management of chronic rhinosinusitis. 3. Currently experiencing an acute exacerbation of CRS or active acute rhinosinusitis. 4. Red-flag signs or symptoms, including high fever, severe headache, meningeal signs, significant or recurrent epistaxis, or orbital symptoms (such as preseptal or orbital cellulitis, enophthalmos, tearing, diplopia, proptosis, vision loss, or optic neuropathy). 5. History of sinonasal surgery. 6. Use of antibiotics or corticosteroids within the previous four weeks, or use of biologic agents or immunosuppressants within the previous three months. 7. Presence of other conditions currently requiring treatment with antibiotics, corticosteroids, or immunosuppressive drugs. 8. Presence of severe or unstable comorbidities that, in the investigator's opinion, could pose a risk or interfere with the evaluation of treatment efficacy (for example: NYHA class IV heart failure, severe hepatic impairment, end-stage renal disease, respiratory failure, uncontrolled diabetes mellitus, progressive malignancy, neuropsychiatric disorders, severe active infection, or high risk of infection due to immunosuppression or immunosuppressive therapy). 9. Coagulation disorders or current use of anticoagulant therapy. 10. Pregnant or breastfeeding women. 11. Allergy to absorbable surgical sutures, local infection or skin lesion at the acupoint area, or any contraindication to thread embedding acupuncture according to the Vietnam Ministry of Health guidelines. 12. Previous experience with thread embedding acupuncture for any condition or acupuncture treatment for rhinosinusitis. 13. Contraindications to standard background therapy, including isotonic saline irrigation, intranasal glucocorticosteroids, or their excipients as assessed by the investigator. 14. Participation in another clinical trial or completion of an interventional study within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Sinonasal Outcome Test-22 score at baseline and every two weeks over eight weeks Patient reported outcome using Sinonasal Outcome Test-22 (SNOT-22) questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in severity of nasal congestion at baseline and every two weeks over eight weeks 100mm Visual Analog Scale (VAS),Change in severity of nasal discharge at baseline and every two weeks over eight weeks 100mm Visual Analog Scale (VAS),Change in severity of facial pain at baseline and every two weeks over eight weeks 100mm Visual Analog Scale (VAS),Change in severity of facial pressure at baseline and every two weeks over eight weeks 100mm Visual Analog Scale (VAS),Change in severity of loss of smell at baseline and every two weeks over eight weeks 100mm Visual Analog Scale (VAS),Change in Modified Lund-Kennedy score at baseline and every two weeks over eight weeks Nasal endoscopy,Need for additional medications during eight weeks Medical records,Acute exacerbation during eight weeks Medical records,Adverse event related to the procedure during eight weeks Patient interviews, medical records, and clinical observations | — |
Countries
Vietnam
Contacts
Public ContactAn Tran
University of Medicine and Pharmacy at Ho Chi Minh City
Outcome results
None listed