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Trial registered on ANZCTR
Registration number
ACTRN12612001293853
Ethics application status
Approved
Date submitted
12/12/2012
Date registered
13/12/2012
Date last updated
14/05/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effectiveness of Swedish massage with aromatic ginger oil in treating chronic low back pain in older adults.
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Scientific title
The effectiveness of Swedish massage with aromatic ginger oil in treating chronic low back pain in older adults: A randomised controlled trial.
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Secondary ID [1]
281637
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None
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Universal Trial Number (UTN)
none
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Trial acronym
none
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain
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Condition category
Condition code
Musculoskeletal
288303
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0
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Other muscular and skeletal disorders
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Alternative and Complementary Medicine
288304
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participant receives a 30-minute Swedish massage with aromatic ginger oil, twice a week for 5 weeks.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
Participant receives the usual care of 30-minute Traditional Thai massage, twice a week for 5 weeks.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain intensity using Short Form McGill Pain Questionnaire (SF-MPQ)
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Assessment method [1]
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Timepoint [1]
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1) Baseline
2) Pre-intervention
3) Post-intervention
4) First Follow-up (6th week)
5) Second Follow-up (15th week)
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Secondary outcome [1]
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Functional ability - using the Oswestry Disability Questionnaire (ODQ)
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Assessment method [1]
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Timepoint [1]
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1) Baseline
2) First Follow-up (6th week)
3) Second Follow-up (15th week)
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Secondary outcome [2]
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Quality of Life by SF-12 health survey (SF-12v2)
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Assessment method [2]
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Timepoint [2]
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1) Baseline
2) First Follow-up (6th week)
3) Second Follow-up (15th week)
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Secondary outcome [3]
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Depression by Geriatric Depression Scale (GDS)
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Assessment method [3]
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Timepoint [3]
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1) Baseline
2) First Follow-up (6th week)
3) Second Follow-up (15th week)
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Eligibility
Key inclusion criteria
1) 60 years and older
2) Able to listen, speak, read and write the Thai language
3) Diagnosed with chronic low back pain (lasting more than 12 weeks) by a medical practitioner
4) New clients or clients who had not received any type of massage 12 weeks before testing.
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Skin diseases
2) Inflammation or infection on back
3) A history of back fracture or back surgery
4) Temperature of more than 38.5 OC on the examination day
5) Hemi/paraparesis
6) Infectious diseases (e.g. tuberculosis or AIDS)
7) Cancer
8) Prior experience of receiving any type of massage for three months before this study
9) Inability to commit to the full course of treatment and follow-up.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation is prepared by a statistician not involved in the study. A randomization schedule is prepared using a random number generated by computer with permuted block randomization (block of 10) prior to the enrolment of the first participant. Another person not involved in the study placed randomized numbers into opaque envelopes. The assignments were placed in sealed opaque numbered envelopes prior to the onset of the study and treatments determined after the baseline assessments had been completed. Each person who met the eligibility criteria was given the next opaque envelope treatment in sequential order.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/06/2011
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Actual
6/06/2011
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Date of last participant enrolment
Anticipated
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Actual
20/07/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Thailand
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State/province [1]
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Ratchaburi Province, Western Thailand
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Griffith University
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Address [1]
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170 Kessels Road
Nathan
QLD 4111
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Christian Univesity of Thailand
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Address
144 Moo7
Don Yaihom district
Muang
Nakhon Pathom province 73000
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Country
Thailand
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Secondary sponsor category [1]
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University
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Name [1]
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Research Centre for Clinical and Community Practice Innovation (RCCCPI)
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Address [1]
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Griffith Health Institute
School of Nursing and Midwifery (Nathan campus)
Griffith University
170 Kessels Road
Nathan
QLD 4111
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
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170 Kessels Road
Nathan
QLD 4111
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
288522
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Approval date [1]
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21/03/2011
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Ethics approval number [1]
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NRS/02/11/HREC
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Ethics committee name [2]
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Ministry of Public Health
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Ethics committee address [2]
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The Institute of Thai Traditional Medicine
Department for Development of Thai Traditional and Alternative Medicine
Ministry of Public Health
Tiwanond Road
Muang
Nonthaburi province 11000
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Ethics committee country [2]
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Thailand
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Date submitted for ethics approval [2]
288523
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Approval date [2]
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30/06/2011
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Ethics approval number [2]
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RLC 0041/54
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Ethics committee name [3]
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Damnoensaduak Hospital
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Ethics committee address [3]
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146 Moo 4
Tanut district
Damnaensaduak
Rachaburi province 70130
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Ethics committee country [3]
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Thailand
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Date submitted for ethics approval [3]
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Approval date [3]
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01/05/2011
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Ethics approval number [3]
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AF 04-010
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Summary
Brief summary
A randomised controlled trial was used to investigate the effect of Swedish massage with ginger oil on older people with chronic low pain pain. Treatment group received Swedish massage with aromatic ginger oil (2% essential ginger oil with Jojoba oil) and Control group received the usual care of traditional Thai massage.
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Trial website
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Trial related presentations / publications
Sritoomma, N., Moyle, W. Cooke, M. & O’Dwyer, S. (2014). The effectiveness of Swedish massage with Aromatic Ginger Oil in treating chronic low back pain in older adults: A Randomised Controlled Trial. Complementary Therapies in Medicine, 22, 26-33.
Sritoomma, N., Moyle, W. Cooke, M. & O’Dwyer, S. (2012). The effectiveness of Swedish massage and traditional Thai massage in treating chronic low back pain: A review of the literature. Complementary Therapies in Clinical Practice, 18, 227-234.
Sritoomma, N., Moyle, W. Cooke, M. & O’Dwyer, S. A randomised controlled trial investigating Swedish massage with aromatic ginger oil in treating chronic low back pain in older adults, oral presentation, TCAM 2012 International Conference Research & Application on Traditional Complementary and Alternative Medicine, 22-23 June 2012, Surakarta, Indonesia.
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Public notes
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Contacts
Principal investigator
Name
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Prof Wendy Moyle
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Address
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170 Kessels Road
Nathan, Brisbane,
QLD 4111
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Country
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Australia
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Phone
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+61 (0) 7 3735 5526
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Netchanok Sritoomma
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Address
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Graduate School, Christian University of Thailand
144 Moo 7, Don Yai Hom, Muang, Nakhonpathom 73000 Thailand
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Country
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Thailand
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Phone
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+66 34229 480-9 Ext 1402
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Wendy Moyle
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Address
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170 Kessels Road
Nathan, Brisbane,
QLD 4111
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Country
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Australia
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Phone
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+61 (0) 7 3735 5526
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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