Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000149369
Ethics application status
Approved
Date submitted
17/03/2008
Date registered
28/03/2008
Date last updated
3/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Ear-acupressure for hay fever
Scientific title
Evaluation of efficacy and safety of ear-acupressure in treating adult patients with allergic rhinitis: A multi-centre, randomised, sham-controlled clinical trial (EAAR)
Secondary ID [1] 259722 0
None.
Universal Trial Number (UTN)
Trial acronym
EAAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 2932 0
Condition category
Condition code
Inflammatory and Immune System 3071 3071 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ear-acupressure, once a week, eight weeks. The ear-acupressure is achieved by using commercial stainless steel press-pellet tapes. The pellet measures 1.2 mm in diameter and is attached to a round adhesive tape 7 mm in diameter in a tan colour which is close to skin colour. During the treatment, five pellets will be taped on the real or sham ear points on one of the participant’s ears. Once taped, the practitioner will press each pellet for 10 seconds or until the ear become red or slightly sore. There is no skin penetration in the treatment. In the following treatment session, the other ear will be used for taping. Thus, the two ears will be used alternately on a weekly basis. The participants will be instructed in the technique of how to press the five pellets three times a day. The pressing technique is to promote the desired stimulation on the AR-specific points in order to achieve the therapeutic effects. The real ear-acupressure treatment will be conducted on five specific ear points for AR. They are Shenmen (TF4), Neibi (TG4), Fei (CO14), Fengxi (SF1,2i) and Shenshangxian (TG2p). These five ear points are recommended to be used for the treatment of AR by the Chinese Standard of Auricular Points.
Intervention code [1] 2664 0
Treatment: Other
Intervention code [2] 2706 0
Treatment: Other
Comparator / control treatment
Sham ear-acupressure, use non-specific points as sham points.
The procedure of the sham ear-acupressure treatment is same as the real treatment. However, the sham ear-acupressure treatment will be conducted five non-AR-specific ear points. They are Lun2 (HX10), Jian (SF4,5), Suogu (SF6), Zhen (AT3), Ya (LO1). These five ear points are not specifically indicated for AR management according to the Chinese Standard of Auricular Points.
Control group
Placebo

Outcomes
Primary outcome [1] 3674 0
Non-nasal symptoms: eye symptoms, throat symptoms, chronic cough, ear symptoms, headache and mental function.
These outcomes will be recorded by participants in a daily diary.
Timepoint [1] 3674 0
Week 0,2,4,6,8 of the treatment,
During and at the end of follow-up.
Primary outcome [2] 3954 0
Changes in the severity of nasal symptoms: sneezing, runny nose, nasal congestion, itchy nose and postnasal drip.
These outcomes will be recorded by participants in a daily diary.
Timepoint [2] 3954 0
Week 0,2,4,6,8 of the treatment,
During and at the end of follow-up.
Secondary outcome [1] 6205 0
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) questionnaire
Timepoint [1] 6205 0
Week 0,2,4,6,8 of the treatment,
During and at the end of follow-up.
Secondary outcome [2] 6206 0
Relief medication usage score
Timepoint [2] 6206 0
Week 0,2,4,6,8 of the treatment,
During and at the end of follow-up.
Secondary outcome [3] 6207 0
Medical expenses related to AR
Timepoint [3] 6207 0
Week 0,2,4,6,8 of the treatment,
During and at the end of follow-up.
Secondary outcome [4] 6208 0
Participants opinion about ear-acupressure.
This opinion will be recorded by participants through a self-administered questionnaire survey.
Timepoint [4] 6208 0
Week 2 and the end of treatment period.
Secondary outcome [5] 6647 0
Quality-of-life assessment of rhinitis severity questionnaire
Timepoint [5] 6647 0
Week 0,2,4,6,8 of the treatment,
During and at the end of follow-up.

Eligibility
Key inclusion criteria
Aged between 18 and 70 years (inclusive); history of at least two years of typical symptoms of AR; positive skin prick test to one or more of the following allergens: Seven-grass mix, Perennial Rye, Ragweed, House mite, Animal’s dander or Mould (RMIT site), or positive serum specific IgE test (GPHCM site); currently not involved in other clinical trials for the treatment of AR; agree to make themselves available for the period of the study; and provide written consent for participation.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current with systematic corticosteroid therapy; other current active respiratory disease such as asthma; nasal polyposis; other structural defects of the upper respiratory tract; wearing a hearing aid; have a history of being allergic to adhesive tape; history of HIV, Hepatitis B or C; pregnancy; used ear-acupressure for respiratory diseases within the last six months; or do not read or understand English (RMIT site).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation codes for all the subjects will be put into sealed, opaque envelopes, which are allocated by a central officer who is unaware of subjects’ characteristics. The subject will be asked to pick one envelop right before the first treatment and pass it to the acupuncturist to open. The acupuncturist will provide either real or sham treatment to the subject following the information in the envelop. The subjects, the data entry personnel and data analyst will not be aware of grouping details.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by an independent statistician using MINITAB Statistical Package. The randomisation outcomes will be kept in a password-secured computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
232
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 718 0
China
State/province [1] 718 0
Guangdong Province

Funding & Sponsors
Funding source category [1] 3184 0
University
Name [1] 3184 0
Charlie Xue
Country [1] 3184 0
Australia
Primary sponsor type
University
Name
Charlie Xue
Address
PO Box 71, Plenty Road, Division of Chinese Medicine, RMIT University, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 2854 0
Hospital
Name [1] 2854 0
Yu Bo Lu
Address [1] 2854 0
111 Dade Road, Guangzhou, Guangdong Province 510120
Country [1] 2854 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5168 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 5168 0
PO Box 71, Plenty Road, Research and Innovation, RMIT University, Bundoora, VIC 3083
Ethics committee country [1] 5168 0
Australia
Date submitted for ethics approval [1] 5168 0
Approval date [1] 5168 0
25/02/2008
Ethics approval number [1] 5168 0
Project No 29/07 Zhang
Ethics committee name [2] 258264 0
Guangdong Provincial Hospital of Chinese Medicine Ethics Committee
Ethics committee address [2] 258264 0
111 Dade Road, Guangzhou, Guangdong Province 510120
Ethics committee country [2] 258264 0
China
Date submitted for ethics approval [2] 258264 0
Approval date [2] 258264 0
09/05/2009
Ethics approval number [2] 258264 0
2008GL-22

Summary
Brief summary
This study proposes to evaluate the efficacy and safety of ear-acupressure in the treatment of adult patients with allergic rhinitis by conducting a multi-centre, randomised, sham-controlled clinical trial.
A pilot study will be conducted in Australia prior to the main trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28271 0
Address 28271 0
Country 28271 0
Phone 28271 0
Fax 28271 0
Email 28271 0
Contact person for public queries
Name 11428 0
Charlie Xue
Address 11428 0
PO Box 71, Plenty Road, Division of Chinese Medicine, Royal Melbourne Institute of Technology (RMIT University), Bundoora, VIC 3083
Country 11428 0
Australia
Phone 11428 0
+(61 3) 9925 7745
Fax 11428 0
+(61 3) 9925 7178
Email 11428 0
[email protected]
Contact person for scientific queries
Name 2356 0
Charlie Xue
Address 2356 0
PO Box 71, Plenty Road, Division of Chinese Medicine, RMIT University, Bundoora, VIC 3083
Country 2356 0
Australia
Phone 2356 0
+(61 3) 9925 7745
Fax 2356 0
+(61 3) 9925 7178
Email 2356 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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