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

NCT ID: NCT01921348

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

acupressure pellets

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

acupressure pellets

Intervention Type: DEVICE

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.

Interventions

acupressure pellets

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Magrain Ion Pellets; Magrain Ion Pellets

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gailen D. Marshall Jr., MD PhD

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gailen D Marshall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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

Jackson, Mississippi, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20447156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18637763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16941973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12125480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19441597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15733625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22654931 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

2013-0165

Identifier Type: -

Identifier Source: org_study_id