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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupressure pellets | Device | The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Measures | Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gailen D Marshall, MD, PhD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20447156 | Background | 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. | |
| 18637763 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | normal individuals with symptomatic allergic rhinitis whose total symptom scores were assessed before and after the intervention |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Enrollment targets were not met for both arms/groups. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis. |
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The target number of participants needed to achieve target power and statistically reliable results was not met.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gailen D. Marshall, Jr., MD, PhD, Director, Division of Clinical Immunology and Allergy | University of MS Medical Center | 6018155527 | gmarshall@umc.edu |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| acupressure pellets | 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. |
|
|
| 16941973 | Background | 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. |
| 12125480 | Background | 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. |
| 19441597 | Background | 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. |
| 15733625 | Background | 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. |
| 22654931 | Background | 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. |
| Background | 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 |
| 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. 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. |
| BG002 | Total | Total of all reporting groups |
There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group. |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
|
| Secondary | Psychological Measures | Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry. | Since the immune biomarker frozen blood samples were not analyzed (due to not meeting recruitment goals), the effects of ear accupressure based upon psychological differences could not be analyzed. | Posted | 8 weeks |
|
|
| Other Pre-specified | 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. | Blood samples were collected and frozen for batch analysis, but not analyzed for data since recruitment goals were not met. | Posted | 8 weeks |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |