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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921348
• Other study ID #: 2013-0165
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: November 24, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Benedetti F. The placebo response: science versus ethics and the vulnerability of the patient. World Psychiatry. 2012 Jun;11(2):70-2. — View 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. Epub 2005 Jan 21. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune biomarkers	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	No
Primary	Rhinoconjunctivitis and Rhinitis Quality of Life questionnaire	Changes in rhinitis symptoms from baseline to 8 weeks	8 weeks	No
Secondary	Psychological Measures	Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.	8 weeks	No