Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000761965
Ethics application status
Approved
Date submitted
19/07/2011
Date registered
20/07/2011
Date last updated
8/08/2019
Date data sharing statement initially provided
8/08/2019
Date results information initially provided
8/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ear-acupressure for smoking cessation: a randomised controlled trial (RCT)
Scientific title
Specific ear-acupressure versus non-specific ear-acupressure for smoking cessation in current smokers
Secondary ID [1] 262655 0
No secondary ID for this trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 268361 0
Condition category
Condition code
Respiratory 268492 268492 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 268507 268507 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ear-acupressure is a non-invasive treatment that involves taping small round pellets onto points in the ear. A two-week run-in period will be used to collect baseline data, including, nicotine withdrawal symptoms record, number of cigarettes smoked daily and record of nicotine replacement thearapy usage.
After a two-week run-in period, each participant will be given ear-acupressure treatment once per week for eight weeks by a registered acupuncturist. Stainless-steel Press-pellet Tapes (Magrain Pellets: Cat. No. PELSST S/Steel Tan, Acuneeds Co., Australia), will be used for this study. The participants will be instructed in the technique of how to press the five pellets three times daily by themselves throughout the week and whenever they feel a craving for cigarettes. During the week, participants will need to record how many pellets remain attached each day in the case report form. At weekly visits, the acupuncturist will remove the remaining pellets and attach new pellets to the same acupuncture points on the ear on the opposite side of the body. The two ears will be used alternately on a weekly basis for the 8 weeks with the left ear being used at first treatment. Participants are required to select a quit date within the first two treatment weeks.
Intervention code [1] 266999 0
Treatment: Other
Comparator / control treatment
Non-specific ear-acupressure as 'sham' control. Due to the large number of acu-points on the ear, it is difficult to construct a plausible non-ear-acupressure control. Therefore, five ear points which are non-specific for smoking cessation will be chosen for the participants assigned to the non-specific control group. There are over 90 acupuncture points on the ear. These five ear points are not known to be used for smoking cessation or respiratory conditions. After a two-week run-in period, each participant will be given non-specific ear-acupressure treatment once per week for eight weeks by a registered acupuncturist.
Control group
Placebo

Outcomes
Primary outcome [1] 269238 0
Smoking cessation assessed by case record form and exhaled CO
Timepoint [1] 269238 0
End of treatment (8 weeks after randomisation), end of follow up (20 weeks after intervention commencement)
Primary outcome [2] 269239 0
Nicotine withdrawal symptoms assessed using the seven item Mood and Physical Symptoms Scale (MPSS)
Timepoint [2] 269239 0
End of treatment (8 weeks after randomisation), end of follow up (20 weeks after intervention commencement)
Secondary outcome [1] 279191 0
Nicotine Replacement Therapy consumption assessed by case record form
Timepoint [1] 279191 0
Baseline, treatment period (8 weeks) and follow up period (12 weeks)
Secondary outcome [2] 279192 0
Number of days of continuous abstinence of cigarette smoking assessed by case report form
Timepoint [2] 279192 0
Baseline, treatment period (8 weeks) and follow up period (12 weeks)
Secondary outcome [3] 279193 0
Frequency of relapses (number of cigarettes used) assessed by case report form
Timepoint [3] 279193 0
Baseline, treatment period (8 weeks) and follow up period (12 weeks)
Secondary outcome [4] 279194 0
Safety profile of ear-acupressure assessed by case report form
Timepoint [4] 279194 0
Treatment period (8 weeks) and follow up period (12 weeks)
Secondary outcome [5] 279195 0
Body weight assessed by measurement by the therapist
Timepoint [5] 279195 0
Baseline, treatment period (8 weeks) and follow up period (12 weeks)
Secondary outcome [6] 279196 0
Quality of life assessed using Short Form-36
Timepoint [6] 279196 0
End of treatment (8 weeks after randomisation), end of follow up (20 weeks after intervention commencement)

Eligibility
Key inclusion criteria
Smoke 10 or more cigarettes a day for at least one year; intend to stop smoking on the agreed quit date; agree to make themselves available for the period of the study; and
provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current pathological condition of the ear (e.g. otitis externa);
2. Wearing a hearing aid;
3. History of allergy to adhesive dressing;
4. Current use of NRT;
5. Currently taking bupropion or varenicline;
6. Currently taking anti-depressant or anti-psychotic medications;
7. Currently undertaking a quit smoking program (e.g. counselling);
8. Current alcohol or substance abuse;
9. Currently enrolled into another clinical study;
10. Pregnancy;
11. Other persons from the same household are included in the study already;
12. Have used ear-acupuncture or ear-acupressure for a respiratory condition and/or smoking cessation within the last 12 months;
13. Are an acupuncture student or a practitioner; or
14. Do not read or 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)
Prior to the first treatment, each participant will be asked to pick one sealed opaque envelope from the pack of all the envelopes. The envelope will be opened by the treating acupuncturist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Completed
Date of first participant enrolment
Anticipated
25/07/2011
Actual
8/08/2011
Date of last participant enrolment
Anticipated
Actual
26/08/2011
Date of last data collection
Anticipated
Actual
13/01/2012
Sample size
Target
45
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4245 0
3083
Recruitment postcode(s) [2] 4246 0
3088
Recruitment postcode(s) [3] 4247 0
3074
Recruitment postcode(s) [4] 4248 0
3082
Recruitment postcode(s) [5] 4249 0
3076
Recruitment postcode(s) [6] 4250 0
3752
Recruitment postcode(s) [7] 4251 0
3754
Recruitment postcode(s) [8] 4253 0
3072
Recruitment postcode(s) [9] 4254 0
3085
Recruitment postcode(s) [10] 4255 0
3084
Recruitment postcode(s) [11] 4256 0
3073

Funding & Sponsors
Funding source category [1] 267476 0
University
Name [1] 267476 0
RMIT University
Country [1] 267476 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
School of Health Sciences
RMIT University
PO Box 71
Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 266518 0
None
Name [1] 266518 0
Address [1] 266518 0
Country [1] 266518 0
Other collaborator category [1] 252112 0
Individual
Name [1] 252112 0
Dr Christopher Worsnop
Address [1] 252112 0
Institute of Breathing and Sleep (IBAS)
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg 3084
Victoria
Country [1] 252112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269441 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 269441 0
Research & Innovation Portfolio Office
GPO Box 2476V
Melbourne VIC 3001
Ethics committee country [1] 269441 0
Australia
Date submitted for ethics approval [1] 269441 0
Approval date [1] 269441 0
08/07/2011
Ethics approval number [1] 269441 0
36/11

Summary
Brief summary
The aim of this randomised controlled trial is to investigate the efficacy of ear-acupressure for smoking cessation, and the effect of ear-acupressure on nicotine withdrawal symptoms. Ear-acupressure is like acupuncture but no needles are used, instead, small round pellets are taped to points on one ear. The study consists of a two week run-in, followed by eight weeks of weekly visits and 12 weeks of follow-up.
Trial website
www.rmit.edu.au/chinese-med
Trial related presentations / publications
1. Ear acupressure for smoking cessation: study protocol for a randomised controlled trial.
Zhang AL1, Di YM, Worsnop C, May BH, Xue CC.
Forsch Komplementmed. 2013;20(4):290-4. doi: 10.1159/000354597. Epub 15/08/2013.

2. Ear acupressure for smoking cessation: a randomised controlled trial.
Zhang AL1, Di YM, Worsnop C, May BH, Da Costa C, Xue CC.
Evid Based Complement Alternat Med. 2013;2013:637073. doi: 10.1155/2013/637073. Epub (28/09/2013).
Public notes

Contacts
Principal investigator
Name 32891 0
Prof Charlie Xue
Address 32891 0
School of Health Sciences RMIT University PO Box 71 Bundoora, VIC 3083
Country 32891 0
Australia
Phone 32891 0
+61 3 9925 7360
Fax 32891 0
Email 32891 0
[email protected]
Contact person for public queries
Name 16138 0
Prof Prof. Charlie Xue
Address 16138 0
School of Health Sciences
RMIT University
PO Box 71
Bundoora, VIC 3083
Country 16138 0
Australia
Phone 16138 0
+61 3 9925 7360
Fax 16138 0
+61 3 9925 7503
Email 16138 0
[email protected]
Contact person for scientific queries
Name 7066 0
Dr Dr. Brian May
Address 7066 0
School of Health Sciences
RMIT University
PO Box 71
Bundoora, VIC 3083
Country 7066 0
Australia
Phone 7066 0
+61 3 9925 7166
Fax 7066 0
+61 3 9925 7178
Email 7066 0
[email protected]

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
3860Study protocolEar acupressure for smoking cessation: study protocol for a randomised controlled trial. Zhang AL1, Di YM, Worsnop C, May BH, Xue CC. Forsch Komplementmed. 2013;20(4):290-4. doi: 10.1159/000354597. Epub 2013 Aug 15.  



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ear acupressure for smoking cessation: a randomise... [More Details]

Documents added automatically
No additional documents have been identified.