Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis

NCT06323304 | Completed

• 1 other identifier: 701/HDDD-DHYD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression. Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy. This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR.

Conditions

Itching; Runny Nose; Sneezing; Nasal Congestion

Keywords

Allergic rhinitis; Auricular acupressure therapy; Traditional medicine

Outcome Measures

Primary Outcomes (1)

• The change of nasal and non nasal symptom scores

  Symptom scores will be assessed based on a visual analogue scale (VAS). It usually consists of a 100 mm line anchored at each end by descriptors.

  Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

Secondary Outcomes (3)

• The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

  Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

• The change of relief medication usage

  Assessments were conducted after each intervention week throughout the four weeks (Week 1, Week 2, Week 3, Week 4)

• Proportion of intervention-related adverse events

  Up to four weeks

Study Arms (2)

Auricular acupressure + fluticasone propionate nasal spray

EXPERIMENTAL

Auricular acupressure therapy (AAT) once a week on the left ear for a total of four weeks (4 sessions). Fluticasone propionate nasal spray will be used whenever symptoms occur.

Other: Auricular acupressure; Other: Standard treatment

Sham acupressure + fluticasone propionate nasal spray

SHAM COMPARATOR

Sham acupressure therapy (SAT) once a week on the left ear for a total of four weeks (4 sessions). Fluticasone propionate nasal spray will be used whenever symptoms occur.

Other: Sham acupressure; Other: Standard treatment

Interventions

Auricular acupressure OTHER

Auricular acupressure therapy will be performed once a week for 4 weeks using Vaccaria seeds, which is an herb in traditional medicine. The acupoints on the ear that will be treated with auricular acupressure therapy are Shenmen (TF4), Internal nose (TG4), Lung (CO14), Wind stream (SF1,2i), Adrenal gland (TG2p). These acupoints are believed to be effective in the treatment of allergic rhinitis. The patches will be kept on the auricle for one week.

Auricular acupressure + fluticasone propionate nasal spray

Sham acupressure OTHER

Sham acupressure therapy will be performed once a week for 4 weeks using Vaccaria seeds. The acupoints that will be treated with auricular acupressure therapy are Helix 2 (HX10), Shoulder (SF4), Clavicle (SF6), Anus (HX5) and Tooth (LO1). These acupoints are not used to treat allergic immune-related problems or respiratory diseases. The patches will be kept on the auricle for one week.

Sham acupressure + fluticasone propionate nasal spray

Standard treatment OTHER

Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of fluticasone propionate nasal spray as needed, and lifestyle modifications.

Auricular acupressure + fluticasone propionate nasal spray; Sham acupressure + fluticasone propionate nasal spray

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must be diagnosed with allergic rhinitis according to the ARIA 2019 (Allergic Rhinitis and its Impact on Asthma) diagnostic criteria, must be between 18 and 60 years old.
• Must have had typical symptoms of allergic rhinitis for at least 2 years.
• Must provide written informed consent to participate in the study.
• Must be mentally alert and able to communicate effectively.
• Must have vital signs within normal limits (pulse, blood pressure, temperature, respiratory rate, SpO2).
• Must not have any other chronic diseases, including respiratory diseases (asthma, pneumonia, chronic obstructive pulmonary disease, etc.), thyroid disease, autonomic nervous system disorders, hypertension, or diabetes, as determined by medical history.
• Must not have any knowledge of auricular therapy.

You may not qualify if:

• Have used decongestants, antihistamines, anticholinergics, or oral corticosteroids within the past 1 week.
• Have undergone auricular acupuncture, auricular acupressure, or other forms of acupuncture for the treatment of other respiratory diseases within the past 6 months.
• Have used stimulants (alcohol, beer, coffee, tobacco) within 24 hours of the study.
• Lesions (scars, tears, scratches, bites) on the left auricle.
• Allergic rhinitis with secondary infection, acute sinusitis or acute exacerbation of chronic sinusitis, or chronic sinusitis.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medical Center HCMC - Branch no.3

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (11)

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Related Links

• Related Info

MeSH Terms

Conditions

Pruritus; Rhinorrhea; Sneezing; Nasal Obstruction; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Rhinitis; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment. The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: March 13, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

VN (1)