Seasonal Allergic Rhinitis
Conditions
Keywords
Hay Fever, Hayfever, Pollen Allergy, Pollinosis, Seasonal Allergic Rhinitis
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.
Interventions
DEVICEacupressure pellets
The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only) | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Measures | 8 weeks | Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune Biomarkers | 8 weeks | Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis. | 9 |
| Sham 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.
acupressure pellets: 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. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Sham | Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 36.9 years STANDARD_DEVIATION 12.1 | 41.9 years STANDARD_DEVIATION 12.1 | 39.4 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
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.
Time frame: 8 weeks
Population: Enrollment targets were not met for both arms/groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only) | 2.36 units on a scale | Standard Deviation 0.89 |
| Sham | Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only) | 2.07 units on a scale | Standard Deviation 1.31 |
Secondary
Psychological Measures
Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.
Time frame: 8 weeks
Population: Since the immune biomarker frozen blood samples were not analyzed (due to not meeting recruitment goals), the effects of ear accupressure based upon psychological differences could not be analyzed.
Other Pre-specified
Immune Biomarkers
Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks.
Time frame: 8 weeks
Population: Blood samples were collected and frozen for batch analysis, but not analyzed for data since recruitment goals were not met.