ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergic Rhinitis

Condition category

Condition code

Respiratory

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]

Treatment: Other

Intervention code [2]

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]

Modulation of the immune response in the upper respiratory tract by acupuncture in patients with allergic rhinitis

Timepoint [1]

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]

Reduction in markers of mucosal inflammation. Mucosal inflammation with be assessed by measuring cytokines in saliva.

Timepoint [1]

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]

Improved quality of life scores

Timepoint [2]

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

Sex

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

29/06/2009

Actual

27/10/2009

Date of last participant enrolment

Anticipated

1/05/2012

Actual

7/06/2012

Date of last data collection

Anticipated

Actual

23/08/2012

Sample size

Target

108

Accrual to date

Final

152

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO BOx 1421
CANBERRA
ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Professor Allan Cripps

Address

Gold Coast campus
Griffith University QLD 4222

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

A/Prof Peter Smith

Address [1]

Queensland Allergy Services
5/123 Nerang Street
Southport QLD
4215

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

A/Prof Caroline Smith

Address [1]

University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Bray Centre
Nathan Campus
Griffith University
Nathan QLD 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/04/2009

Approval date [1]

21/05/2009

Ethics approval number [1]

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

Prof Allan Cripps

Address

Gold Coast Campus
Griffith University QLD 4222

Country

Australia

Phone

+61 7 56780711

Fax

+61 7 56780795

allan.cripps@griffith.edu.au

Contact person for public queries

Name

Professor Allan Cripps

Address

Gold Coast campus
Griffith University QLD 4222

Country

Australia

Phone

+61 7 56780711

Fax

+61 7 56780795

allan.cripps@griffith.edu.au

Contact person for scientific queries

Name

Professor Allan Cripps

Address

Gold Coast campus
Griffith University QLD 4222

Country

Australia

Phone

+61 7 56780711

Fax

+61 7 56780795

allan.cripps@griffith.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of acupuncture on house dust mite specific IgE, substance P, and symptoms in persistent allergic rhinitis.	2016	https://dx.doi.org/10.1016/j.anai.2016.04.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

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