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Trial registered on ANZCTR


Registration number
ACTRN12610001052022
Ethics application status
Approved
Date submitted
26/05/2009
Date registered
30/11/2010
Date last updated
5/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture and mucosal immunity in the upper respiratory tract
Scientific title
The effect of acupuncture on mucosal immunity in the upper respiratory tract in allergic rhinitis patients
Secondary ID [1] 253155 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 4856 0
Condition category
Condition code
Respiratory 237205 237205 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each acupuncture session will last for approximately 30 minutes including 20 minutes of needle retention time between the insertion and withdrawal of the needles. These 30 minute sessions will occur twice weekly for 8 weeks.
Manipulation refers to a broad range of traditional Chinese acupuncture techniques. In this study the real acupuncture group will receive a manipulation known as “ping bu ping xie” (even supplementation and draining) which is a combination of simultaneous lift and thrust (ti cha bu xie) and twist and rotate (nian zhuan bu xie). This technique involves minute changes to the depth of the needle combined with minute rotation of the needle handle (less than 180o). Manipulation does not refer to either the insertion or withdrawal of the needle, but is confined to techniques applied to the needle between insertion and withdrawal.
The 8 sites for the real acupuncture group will be: GV 23, Yintang (both on the midline); LI 20, LI 4, ST 36 will be needled bilaterally. All real acupuncture points will be located according to the WHO Standard Acupuncture Point Locations in the Western Pacific Region published by the World Health Organisation, Western Pacific Regional Office.
Intervention code [1] 236640 0
Treatment: Other
Intervention code [2] 257659 0
Not applicable
Comparator / control treatment
Each acupuncture session will last for approximately 30 minutes including 20 minutes of needle retention time between the insertion and withdrawal of the needles. These 30 minute sessions will occur twice weekly for 8 weeks.
Sham acupuncture protocols currently used in acupuncture research typically use either non-invasive simulations of acupuncture on real acupuncture points (such as the Streitberger/Kleinhenz, Park or Takamura “placebo acupuncture needle” devices) or skin-penetrating acupuncture with a normal acupuncture needle at points which are either real acupuncture points which are regarded as clinically irrelevant to the condition treated, or else at sites which do not correspond to real acupuncture points and which do not lie on known acupuncture channels/meridians. In this trial, skin-penetrating acupuncture (with 0.25 x 40 mm needles, the same needles as the real acupuncture group) at “non-channel points” will be used. The sham acupuncture group will be needled at a total of 8 non-channel points, and to match the real acupuncture group, these points will also be located on the head, face, hands and legs
Control group
Placebo

Outcomes
Primary outcome [1] 238017 0
Modulation of the immune response in the upper respiratory tract by acupuncture in patients with allergic rhinitis
Timepoint [1] 238017 0
Clinical assessment will occur at weeks 0, 9 and 13 after the commencement of treatment.
Daily symptom and medication diary.
Rhinmanometry at weeks 0, 9 and 13.
Immune parameters in salia samples at weeks 0, 3, 6, 9 and 13.
Immune paraameters in blood samples at weeks 0, 9 and 13.
Secondary outcome [1] 242160 0
Reduction in markers of mucosal inflammation. Mucosal inflammation with be assessed by measuring cytokines in saliva.
Timepoint [1] 242160 0
Immune parameters in saliva samples at weeks 0, 3, 6, 9 and 13 Immune parameters in blood samples at weeks 0, 9 and 13
Secondary outcome [2] 242309 0
Improved quality of life scores
Timepoint [2] 242309 0
A Rhinoconjunctivitis Qualify of Life Questionnare (RQLQ) will be conducted at weeks 0, 9 and 13

Eligibility
Key inclusion criteria
Males or females aged 18-30 years with more than a 2 year history of moderate to severe allergic rhinitis, positive skin prick test and radio-allergosorbent test to Dermatophagoides. pteronyssinus or Bermunda grass.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non allergic rhinitis; negative on skin prick test and radioallergosorbent test to D. pteronyssinus or Bermuda grass; acupuncture treatment for allergic rhinitis or specific immunotherpy in the previous 2 years; respiratory diseases, such as asthma, nasal polyposis and Chronic Obstructive Pulmonary Disease; infectious diseases; medications which effect salivary flow and components such as systemic corticosteroids, diuretics and antidepressants.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent and the respective entry criteria being met, participants will be randomly assigned to a treatment group using a computer generated, blocked random-allocation sequence by a research officer not associated with the study. This research officer will then inform the researchers of the treatment assignment. As this will be an open study neither participants nor researchers will be blinded to the treatment assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to a treatment group using a computer generated, blocked random-allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 5021 0
Government body
Name [1] 5021 0
National Health and Medical Research Council (NHMRC)
Address [1] 5021 0
GPO BOx 1421
CANBERRA
ACT 2601
Country [1] 5021 0
Australia
Primary sponsor type
University
Name
Professor Allan Cripps
Address
Gold Coast campus
Griffith University QLD 4222
Country
Australia
Secondary sponsor category [1] 4541 0
Individual
Name [1] 4541 0
A/Prof Peter Smith
Address [1] 4541 0
Queensland Allergy Services
5/123 Nerang Street
Southport QLD
4215
Country [1] 4541 0
Australia
Other collaborator category [1] 682 0
University
Name [1] 682 0
A/Prof Caroline Smith
Address [1] 682 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country [1] 682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7119 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 7119 0
Office for Research
Bray Centre
Nathan Campus
Griffith University
Nathan QLD 4111
Ethics committee country [1] 7119 0
Australia
Date submitted for ethics approval [1] 7119 0
17/04/2009
Approval date [1] 7119 0
21/05/2009
Ethics approval number [1] 7119 0
MED/02/09/HREC

Summary
Brief summary
There is evidence to suggest that acupuncture can modulate both non-specific and specific immunity. Published literature suggests that this modulation is most prominent in subjects with chronic inflammatory diseases including allergic rhinitis. Claims are also made regarding the “uniqueness” of acupuncture treatment in that it can have differing effects with an identical stimulus, depending on the starting state of the organism. The overall objective of this research is to investigate the effects of acupuncture on the mucosal immune response in the upper respiratory tract. We will study patients with allergic rhinitis where there is evidence that acupuncture treatment is clinically beneficial. We will also study healthy subjects without allergic disease to investigate any differences in effects that the same acupuncture treatment might have on mucosal immune responses compared to patients with allergic rhinitis.
Trial website
Trial related presentations / publications
1. McDonald, JL,. Cripps, AW, Smith, PK, Smith, CA, Xue, CL, Golianu, B
(2011) The Effects of Acupuncture on Mucosal Immunity in the Upper
Respiratory Tract. (poster) Gold Coast Health and Medical Research
Conference, Seaworld Nara Resort, Gold Coast, Queensland, Australia
2. McDonald, J.L., Cripps, A.W., Smith, P.K., Smith, C.A., Xue, C.C. & Golianu, B. (2013) The Anti-inflammatory Effects of Acupuncture and Their Relevance to Allergic Rhinitis: A Narrative Review and Proposed Model. Evidence-Based Complementary and Alternative Medicine, Vol 2013, Article ID 591796.
3. McDonald, JL,. Cripps, AW, Smith, PK, Smith, CA, Xue, CL, Golianu, B
(2013) The effects of acupuncture on mucosal immunity in perennial
allergic rhinitis: a randomised, subject-and-assessor-blinded, sham-
controlled clinical trial. World Federation of Acupuncture-Moxibustion
Societies 8th World Conference on Acupuncture, Sydney
4. McDonald, J.L., Cripps, A.W., Smith, P.K., Smith, C.A., Xue, C.C. & Golianu, B. (2013) The effects of acupuncture on mucosal immunity in perennial allergic rhinitis: a randomised, subject-and-assessor-blinded, sham-controlled clinical trial [WFAS Sydney 2013 selected peer-reviewed conference abstracts] Australian Journal of Acupuncture and Chinese Medicine 8(2):30-31
5. McDonald, JL,. Cripps, AW, Smith, PK, Smith, CA, Xue, CL, Golianu, B
(2014) The effects of acupuncture on mucosal immunity in persistent allergic rhinitis: a randomised, subject-and-assessor-blinded, sham-controlled clinical trial: final results. Australasian Acupuncture & Chinese Medicine Annual Conference (AACMAC), Melbourne
6. McDonald, JL, Cripps, AW, Smith, PK, Smith, CA, Xue, CL, Golianu, B
(2015) Acupuncture modulates mucosal immunity and improves signs and symptoms and quality of life in persistent allergic rhinitis. Australasian Acupuncture & Chinese Medicine Annual Conference (AACMAC), Adelaide
7. McDonald, JL, Cripps, AW, Smith, PK, Smith, CA, Xue, CL, Golianu, B
(2015) Acupuncture down-regulates house dust mite sepcific IgE and substance P and improves signs and symptoms and quality of life in adults with persistent allergic rhinitis Society for Acupuncture Research Conference, Boston, 2015 (poster)
8. McDonald, J.L., Cripps, A.W., Smith, P.K. (2015) Mediators, Receptors and Signalling Pathways in the Anti-Inflammatory and Antihyperalgesic Effects of Acupuncture. Evidence-Based Complementary and Alternative Medicine, Vol 2015, Article ID 975632.
9. McDonald, J.L., Cripps, A.W., Smith, P.K., Smith, C.A., Xue, C.C. & Golianu, B. (2016) Effect of acupuncture on house dust mite specific IgE, substance P, and symptoms in persistent allergic rhinitis. Annals of Allergy, Asthma & Immunology (116) 6: 497–505


Public notes

Contacts
Principal investigator
Name 29649 0
Prof Allan Cripps
Address 29649 0
Gold Coast Campus
Griffith University QLD 4222
Country 29649 0
Australia
Phone 29649 0
+61 7 56780711
Fax 29649 0
+61 7 56780795
Email 29649 0
allan.cripps@griffith.edu.au
Contact person for public queries
Name 12896 0
Prof Professor Allan Cripps
Address 12896 0
Gold Coast campus
Griffith University QLD 4222
Country 12896 0
Australia
Phone 12896 0
+61 7 56780711
Fax 12896 0
+61 7 56780795
Email 12896 0
allan.cripps@griffith.edu.au
Contact person for scientific queries
Name 3824 0
Prof Professor Allan Cripps
Address 3824 0
Gold Coast campus
Griffith University QLD 4222
Country 3824 0
Australia
Phone 3824 0
+61 7 56780711
Fax 3824 0
+61 7 56780795
Email 3824 0
allan.cripps@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary