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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupressure pellets
acupressure pellets
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Hay Fever, Hayfever, Pollen Allergy, Pollinosis, Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2013
Last Updated
May 23, 2017
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01921348
Brief Title
Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis
Official Title
Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Target enrollment not met within specific time period.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Hay Fever, Hayfever, Pollen Allergy, Pollinosis, Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
acupressure pellets
Other Intervention Name(s)
Magrain Ion Pellets
Intervention Description
The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
Intervention Type
Device
Intervention Name(s)
acupressure pellets
Other Intervention Name(s)
Magrain Ion Pellets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only)
Description
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
Secondary Outcome Measure Information:
Title
Psychological Measures
Description
Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Immune Biomarkers
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gailen D Marshall, MD, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20447156
Citation
Zhang CS, Yang AW, Zhang AL, Fu WB, Thien FU, Lewith G, Xue CC. Ear-acupressure for allergic rhinitis: a systematic review. Clin Otolaryngol. 2010 Feb;35(1):6-12. doi: 10.1111/j.1749-4486.2009.02067.x.
Results Reference
background
PubMed Identifier
18637763
Citation
Shiue HS, Lee YS, Tsai CN, Hsueh YM, Sheu JR, Chang HH. DNA microarray analysis of the effect on inflammation in patients treated with acupuncture for allergic rhinitis. J Altern Complement Med. 2008 Jul;14(6):689-98. doi: 10.1089/acm.2007.0669.
Results Reference
background
PubMed Identifier
16941973
Citation
Rao YQ, Han NY. [Therapeutic effect of acupuncture on allergic rhinitis and its effects on immunologic function]. Zhongguo Zhen Jiu. 2006 Aug;26(8):557-60. Chinese.
Results Reference
background
PubMed Identifier
12125480
Citation
Petti FB, Liguori A, Ippoliti F. Study on cytokines IL-2, IL-6, IL-10 in patients of chronic allergic rhinitis treated with acupuncture. J Tradit Chin Med. 2002 Jun;22(2):104-11.
Results Reference
background
PubMed Identifier
19441597
Citation
Lee MS, Pittler MH, Shin BC, Kim JI, Ernst E. Acupuncture for allergic rhinitis: a systematic review. Ann Allergy Asthma Immunol. 2009 Apr;102(4):269-79; quiz 279-81, 307. doi: 10.1016/S1081-1206(10)60330-4.
Results Reference
background
PubMed Identifier
15733625
Citation
Finniss DG, Benedetti F. Mechanisms of the placebo response and their impact on clinical trials and clinical practice. Pain. 2005 Mar;114(1-2):3-6. doi: 10.1016/j.pain.2004.12.012. Epub 2005 Jan 21. No abstract available.
Results Reference
background
PubMed Identifier
22654931
Citation
Benedetti F. The placebo response: science versus ethics and the vulnerability of the patient. World Psychiatry. 2012 Jun;11(2):70-2. doi: 10.1016/j.wpsyc.2012.05.003. No abstract available.
Results Reference
background
Citation
Zheng MF, Lin C, Zheng LP, He FR, Effects of acupuncture-moxibustion on monocyte Th1/Th2 cytokine in peripheral blood of patients with perennial allergic rhinitis, Journal of Acupuncture and Tuina Science 2010;8:85-88
Results Reference
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Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

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