Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis by changing the immune parameters and the psychological impact factors are associated with ear acupressure treatment outcome.

Detailed Description
-----------------
The purpose of the study is to investigate the clinical potential of ear acupressure in treating seasonal allergic rhinitis. We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis by changing the immune parameters and the psychological impact factors such as expectation, stress, depression, and anxiety can moderate the ear acupressure treatment effectiveness in allergic rhinitis by influencing the immune parameters.

Official Title
-----------------
Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Device: acupressure pellets
* Device: acupressure pellets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seasonal allergic rhinitis was diagnosed both by history and clinical examination and by the presence at positive skin prick tests All participants need to have at least 2 years of seasonal allergic rhinitis symptoms and a positive skin prick test to one or more pollen allergens Exclusion Criteria: use of systemic corticosteroids within past 3 months period, active asthma, hearing aid usage, history of adhesive tape allergy, history of metal allergy, HIV, hepatitis B or C, history of hematologic, autoimmune, or malignant disease, pregnancy or lactation, ear acupressure (EAP) or acupuncture for respiratory disease within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. | Device: acupressure pellets<br>* The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.<br>* Other names: Magrain Ion Pellets;|
| Sham Comparator: Sham<br>33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel. | Device: acupressure pellets<br>* The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.<br>* Other names: Magrain Ion Pellets;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only) | RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment). In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum. Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Measures | Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hayfever, Pollen Allergy, Pollinosis, Seasonal Allergic Rhinitis, Hay Fever