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

Not Applicable
Terminated
Conditions
Seasonal Allergic Rhinitis
Interventions
Device: acupressure pellets
Registration Number
NCT01921348
Lead Sponsor
University of Mississippi Medical Center
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
18
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatmentacupressure pellets34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
Shamacupressure pellets33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Psychological Measures8 weeks

Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.

Trial Locations

Locations (1)

University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic

🇺🇸

Jackson, Mississippi, United States

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