NCT01921348

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

August 8, 2013

Results QC Date

March 6, 2017

Last Update Submit

May 23, 2017

Conditions

Seasonal Allergic Rhinitis

Keywords

Hay FeverHayfeverPollen AllergyPollinosisSeasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (1)

  • Psychological Measures

    8 weeks

Other Outcomes (1)

  • Immune Biomarkers

    8 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Interventions

acupressure pelletsDEVICE

The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.

Also known as: Magrain Ion Pellets
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jackson, Mississippi, 39216, United States

Location

Related Publications (8)

  • 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.

    PMID: 20447156BACKGROUND

  • 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.

    PMID: 18637763BACKGROUND

  • 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.

    PMID: 16941973BACKGROUND

  • 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.

    PMID: 12125480BACKGROUND

  • 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.

    PMID: 19441597BACKGROUND

  • 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.

    PMID: 15733625BACKGROUND

  • 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.

    PMID: 22654931BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

The target number of participants needed to achieve target power and statistically reliable results was not met.

Results Point of Contact

Title
Gailen D. Marshall, Jr., MD, PhD, Director, Division of Clinical Immunology and Allergy
Organization
University of MS Medical Center
gmarshall@umc.edu
6018155527

Study Officials

  • Gailen D Marshall, MD, PhD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 27, 2017

Results First Posted

June 27, 2017

Record last verified: 2017-05

Locations

US(1)