Seasonal Allergic RhinitisNCT01921348
Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis
A study testing acupressure pellets in people with Seasonal Allergic Rhinitis, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- acupressure pellets
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- use of systemic corticosteroids within past 3 months period,
- active asthma,
- hearing aid usage,
- history of adhesive tape allergy,
- history of metal allergy,
- HIV,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
Jackson, Mississippi, 39216
About this study
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.
Read the 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
- Being tested
- acupressure pellets
- Keywords
- Hay Fever, Hayfever, Pollen Allergy, Pollinosis, Seasonal Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure pelletsDevice
Also called Magrain Ion Pellets
The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
acupressure pelletsDevice
Also called Magrain Ion 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: acupressure pellets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Psychological Measures
Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Target enrollment not met within specific time period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center
- Investigators
- Gailen D Marshall, MD, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921348
- Sponsor's protocol ID
- 2013-0165
- Status last verified
- May 2017
- First submitted
- 8 Aug 2013
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20447156Shiue 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.
PubMed 18637763Rao 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.
PubMed 16941973Petti 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.
PubMed 12125480Lee 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.
PubMed 19441597Finniss 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.
PubMed 15733625Benedetti 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.
PubMed 22654931Zheng 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01921348
- Acronym / sponsor ID
- 2013-0165
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Hay Fever, Hayfever, Pollen Allergy, Pollinosis, Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target enrollment not met within specific time period.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: acupressure pellets34 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 | Device: acupressure pellets33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- use of systemic corticosteroids within past 3 months period,
- active asthma,
- hearing aid usage,
- history of adhesive tape allergy,
- history of metal allergy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure pelletsAlso: Magrain Ion PelletsThe treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis. | Device | Treatment |
| acupressure pelletsAlso: Magrain Ion PelletsThe sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis. | Device | Sham |
Primary outcome
Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only)
Time frame: 8 weeks
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.
1 secondary outcome
Psychological Measures
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20447156Zhang 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.
- Background: PubMed 18637763Shiue 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.
- Background: PubMed 16941973Rao 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.
- Background: PubMed 12125480Petti 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.
- Background: PubMed 19441597Lee 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.
- Background: PubMed 15733625Finniss 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.
- Background: PubMed 22654931Benedetti 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.
- BackgroundZheng 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gailen D Marshall, MD, PhD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure pellets in people with Seasonal Allergic Rhinitis, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01921348, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.