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

May 23, 2017 updated by: Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Magrain Ion Pellets
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 Names:
  • 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 treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
Other Names:
  • Magrain Ion Pellets
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 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)
Time Frame: 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.
8 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Biomarkers
Time Frame: 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Gailen D Marshall, MD, PhD, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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