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Trial registered on ANZCTR

Registration number

ACTRN12617001106325

Ethics application status

Approved

Date submitted

25/07/2017

Date registered

28/07/2017

Date last updated

16/12/2020

Date data sharing statement initially provided

20/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Self-administered acupressure for the management of allergic rhinitis

Scientific title

Effects of self-administered specific acupressure versus non-specific acupressure for the management of allergic rhinitis

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1199-8020

Trial acronym

ARCT

Linked study record

Health condition

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

Allergic rhinitis

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Inflammatory and Immune System

Allergies

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will complete self-administered questionnaires for the severity of symptoms, quality of life and medication use during the 1-week run-in period. After randomisation at the first visit to the clinic laboratory during the treatment period, the registered acupuncturist will provide detailed instructions to each participant in a 15-minute session on a one-on-one basis. Each participant will also receive an information sheet ("Location of 5 Acupoints for Self-administered Acupressure") showing the details of the location of acupuncture points and administration.

Participants in specific acupressure group will perform self-administered acupressure to five specific acupuncture points bilaterally, including Hegu (LI 4), Shangxing (GV 23), Zanzhu (BL 2), Yingxiang (LI 20) and Fengchi (GB 20). Participants will apply pressure to each acupuncture point for one minute, twice a day for four consecutive weeks. Participants will be asked to have a 10-minute one-on-one weekly visit for the four-week intervention period. The same acupuncturist will reinforce the participants' self-administered acupressure skills in every visit during the treatment period and ensure their techniques are correct.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Participants will complete self-administered questionnaires for the severity of symptoms, quality of life and medication use during the 1-week run-in period. After randomisation at the first visit to the clinic laboratory during the treatment period, the registered acupuncturist will provide detailed instructions to each participant in a 15-minute session on a one-on-one basis. Each participant will also receive an information sheet ("Location of 5 Acupoints for Self-administered Acupressure") showing the details of the location of acupuncture points and administration.

Participants in the control group will perform self-administered acupressure on five non-specific acupuncture points, including Extra-Luozhen, Baihui (GV 20), Hanyan (GB 4), Quanliao (SI 18) and Wangu (GB 12). Participants will apply pressure to each acupuncture point for one minute, twice a day for four consecutive weeks. Participants will be asked to have a 10-minute one-on-one weekly visit for the four-week intervention period. The same acupuncturist will reinforce the participants' self-administered acupressure skills in every visit during the treatment period and ensure their techniques are correct.

Control group

Placebo

Outcomes

Primary outcome [1]

Symptom scores assessed by 7-point scale questionnaire in the severity of symptoms

Timepoint [1]

Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).

Secondary outcome [1]

Quality of life assessed by Rhinoconjuctivitis Quality of Life Questionnaire with Standardised Activities (RQLQs)

Timepoint [1]

Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).

Secondary outcome [2]

Medication usage (name, dose and frequency of Western medication used for managing allergic rhinitis symptoms) recorded in the Medication use form

Timepoint [2]

Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).

Secondary outcome [3]

Adverse events of self-administered acupressure recorded in adverse event form (eg. pain in the acupuncture point regions)

Timepoint [3]

Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).

Secondary outcome [4]

Participants’ opinion about self-administered acupressure by Participants’ Opinion of Self-administered Acupressure Credibility Expectancy Questionnaire (9-point scale)

Timepoint [4]

At the first week and the final week of the 4-week treatment period

Eligibility

Key inclusion criteria

• Aged 18 years old and above;
• A history of at least two years of typical symptoms of allergic rhinitis;
• Have a positive skin prick test to one or more of the allergens such as Seven-grass mix, Perennial Rye, Ragweed, House mite, Animal’s dander or Mould;
• Currently not involved in other clinical trials for the treatment of allergic rhinitis;
• Provide written consent for participant to sign;
• Have access to computer and internet; and
• Will not travel overseas or interstates for the 14 weeks of trial period.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Current systemic corticosteroid therapy;
• Other current active respiratory disease such as asthma;
• Nasal polyposis;
• Other structural defects of the upper respiratory tract;
• History of HIV, Hepatitis B or C;
• Current pregnancy;
• Have used acupuncture/acupressure for respiratory or allergic diseases within the last month;
• Chinese herbal medicine practitioner, acupuncturist, past or current Chinese medicine student;
• Travel overseas or interstates in the 14 weeks of trial period; or
• Do not understand English.

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)

Each computer generated random number will be kept in a sealed opaque envelope until the participant is randomised prior to the first treatment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation sequence will be computer generated by an independent researcher.

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

The grouping information will only be known to the registered acupuncturist who will provide instructions to the participants. This acupuncturist will not disclose the grouping information to the participants or other trial investigators.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Data analysis will be conducted using the Statistical Package for Social Science (SPSS).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

31/07/2017

Actual

1/11/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

110

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University

Address [1]

School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083

Country [1]

Australia

Primary sponsor type

University

Name

RMIT University

Address

School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT University Human Research Ethics Committee

Ethics committee address [1]

Research and Innovation office
GPO Box 2476
MELBOURNE VIC 3001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/06/2017

Ethics approval number [1]

20742

Summary

Brief summary

This randomised controlled trial aims to investigate the efficacy and safety of self-administered acupressure for the management of allergic rhinitis. Acupressure is a subtype of acupuncture without needle insertion. It applies fingers to press points on the body. The study consists of 1-week run-in, 4-week treatment and 4-week follow-up period.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Angela Yang

Address

School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7175

Fax

[email protected]

Contact person for public queries

Name

Angela Yang

Address

School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7175

Fax

[email protected]

Contact person for scientific queries

Name

Angela Yang

Address

School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7175

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10059	Study protocol		https://doi.org/10.1186/s13063-019-3495-0

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	Self-administered acupressure for allergic rhinitis: Study protocol for a randomized, single-blind, non-specific controlled, parallel trial.	2019	https://dx.doi.org/10.1186/s13063-019-3495-0

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

Trial Review

Documents added manually

Documents added automatically