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

This study is currently recruiting participants.
Verified February 2014 by University of Mississippi Medical Center
Sponsor:
Information provided by (Responsible Party):
Gailen D. Marshall, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01921348
First received: August 8, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Seasonal Allergic Rhinitis
Device: acupressure pellets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Rhinoconjunctivitis and Rhinitis Quality of Life questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Changes in rhinitis symptoms from baseline to 8 weeks


Secondary Outcome Measures:
  • Psychological Measures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.


Other Outcome Measures:
  • Immune biomarkers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
33 participants will be randomized to not wear acupressure pellets and not apply pressure to the ear.
Experimental: Treatment
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
The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
Other Name: Magrain Ion Pellets
Sham Comparator: 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.
Device: 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.
Other Name: Magrain Ion Pellets

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01921348

Contacts
Contact: Denise D Montgomery, MT 601-815-5374 ddmontgomery@umc.edu
Contact: Kristina E Rehm, PhD 601-815-5527 krehm@umc.edu

Locations
United States, Mississippi
University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Denise D Montgomery, MT    601-815-5374    ddmontgomery@umc.edu   
Principal Investigator: Gailen D Marshall, MD, PhD         
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Gailen D Marshall, MD, PhD University of Mississippi Medical Center
  More Information

Publications:
Responsible Party: Gailen D. Marshall, Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01921348     History of Changes
Other Study ID Numbers: 2013-0165
Study First Received: August 8, 2013
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Hay Fever
Hayfever
Pollen Allergy
Pollinosis
Seasonal Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014