Trial Review

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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] 292523 0
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 304169 0
Condition category
Condition code
Alternative and Complementary Medicine 303495 303495 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 303517 303517 0 0
Allergies
Respiratory 303518 303518 0 0
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] 298707 0
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] 302872 0
Symptom scores assessed by 7-point scale questionnaire in the severity of symptoms
Timepoint [1] 302872 0
Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).
Secondary outcome [1] 337275 0
Quality of life assessed by Rhinoconjuctivitis Quality of Life Questionnaire with Standardised Activities (RQLQs)
Timepoint [1] 337275 0
Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).
Secondary outcome [2] 337276 0
Medication usage (name, dose and frequency of Western medication used for managing allergic rhinitis symptoms) recorded in the Medication use form
Timepoint [2] 337276 0
Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).
Secondary outcome [3] 337277 0
Adverse events of self-administered acupressure recorded in adverse event form (eg. pain in the acupuncture point regions)
Timepoint [3] 337277 0
Baseline, end of treatment (4 weeks) and end of follow-up period (4 weeks).
Secondary outcome [4] 337278 0
Participants’ opinion about self-administered acupressure by Participants’ Opinion of Self-administered Acupressure Credibility Expectancy Questionnaire (9-point scale)
Timepoint [4] 337278 0
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?
No
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
51
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297091 0
University
Name [1] 297091 0
RMIT University
Country [1] 297091 0
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] 296099 0
None
Name [1] 296099 0
Address [1] 296099 0
Country [1] 296099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298269 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 298269 0
Research and Innovation office
GPO Box 2476
MELBOURNE VIC 3001
Ethics committee country [1] 298269 0
Australia
Date submitted for ethics approval [1] 298269 0
Approval date [1] 298269 0
02/06/2017
Ethics approval number [1] 298269 0
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 76538 0
Dr Angela Yang
Address 76538 0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083
Country 76538 0
Australia
Phone 76538 0
+61 3 9925 7175
Fax 76538 0
Email 76538 0
angela.yang@rmit.edu.au
Contact person for public queries
Name 76539 0
Dr Angela Yang
Address 76539 0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083
Country 76539 0
Australia
Phone 76539 0
+61 3 9925 7175
Fax 76539 0
Email 76539 0
angela.yang@rmit.edu.au
Contact person for scientific queries
Name 76540 0
Dr Angela Yang
Address 76540 0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora VIC 3083
Country 76540 0
Australia
Phone 76540 0
+61 3 9925 7175
Fax 76540 0
Email 76540 0
angela.yang@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10059Study 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
SourceTitleYear of PublicationDOI
EmbaseSelf-administered acupressure for allergic rhinitis: Study protocol for a randomized, single-blind, non-specific controlled, parallel trial.2019https://dx.doi.org/10.1186/s13063-019-3495-0
N.B. These documents automatically identified may not have been verified by the study sponsor.