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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.
Scientific title
The effectiveness of Swedish massage with aromatic ginger oil in treating chronic low back pain in older adults: A randomised controlled trial.
Secondary ID [1] 281637 0
None
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 287923 0
Condition category
Condition code
Musculoskeletal 288303 288303 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 288304 288304 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participant receives a 30-minute Swedish massage with aromatic ginger oil, twice a week for 5 weeks.
Intervention code [1] 286175 0
Treatment: Other
Comparator / control treatment
Participant receives the usual care of 30-minute Traditional Thai massage, twice a week for 5 weeks.
Control group
Active

Outcomes
Primary outcome [1] 288480 0
Pain intensity using Short Form McGill Pain Questionnaire (SF-MPQ)
Timepoint [1] 288480 0
1) Baseline
2) Pre-intervention
3) Post-intervention
4) First Follow-up (6th week)
5) Second Follow-up (15th week)
Secondary outcome [1] 300277 0
Functional ability - using the Oswestry Disability Questionnaire (ODQ)
Timepoint [1] 300277 0
1) Baseline
2) First Follow-up (6th week)
3) Second Follow-up (15th week)
Secondary outcome [2] 300278 0
Quality of Life by SF-12 health survey (SF-12v2)
Timepoint [2] 300278 0
1) Baseline
2) First Follow-up (6th week)
3) Second Follow-up (15th week)
Secondary outcome [3] 300279 0
Depression by Geriatric Depression Scale (GDS)
Timepoint [3] 300279 0
1) Baseline
2) First Follow-up (6th week)
3) Second Follow-up (15th week)

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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2011
Actual
6/06/2011
Date of last participant enrolment
Anticipated
Actual
20/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4738 0
Thailand
State/province [1] 4738 0
Ratchaburi Province, Western Thailand

Funding & Sponsors
Funding source category [1] 286455 0
University
Name [1] 286455 0
Griffith University
Country [1] 286455 0
Australia
Primary sponsor type
University
Name
Christian Univesity of Thailand
Address
144 Moo7
Don Yaihom district
Muang
Nakhon Pathom province 73000
Country
Thailand
Secondary sponsor category [1] 285244 0
University
Name [1] 285244 0
Research Centre for Clinical and Community Practice Innovation (RCCCPI)
Address [1] 285244 0
Griffith Health Institute
School of Nursing and Midwifery (Nathan campus)
Griffith University
170 Kessels Road
Nathan
QLD 4111
Country [1] 285244 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288522 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 288522 0
Ethics committee country [1] 288522 0
Australia
Date submitted for ethics approval [1] 288522 0
Approval date [1] 288522 0
21/03/2011
Ethics approval number [1] 288522 0
NRS/02/11/HREC
Ethics committee name [2] 288523 0
Ministry of Public Health
Ethics committee address [2] 288523 0
Ethics committee country [2] 288523 0
Thailand
Date submitted for ethics approval [2] 288523 0
Approval date [2] 288523 0
30/06/2011
Ethics approval number [2] 288523 0
RLC 0041/54
Ethics committee name [3] 288524 0
Damnoensaduak Hospital
Ethics committee address [3] 288524 0
Ethics committee country [3] 288524 0
Thailand
Date submitted for ethics approval [3] 288524 0
Approval date [3] 288524 0
01/05/2011
Ethics approval number [3] 288524 0
AF 04-010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36474 0
Prof Wendy Moyle
Address 36474 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 36474 0
Australia
Phone 36474 0
+61 (0) 7 3735 5526
Fax 36474 0
Email 36474 0
[email protected]
Contact person for public queries
Name 36475 0
Netchanok Sritoomma
Address 36475 0
Graduate School, Christian University of Thailand
144 Moo 7, Don Yai Hom, Muang, Nakhonpathom 73000 Thailand
Country 36475 0
Thailand
Phone 36475 0
+66 34229 480-9 Ext 1402
Fax 36475 0
Email 36475 0
[email protected]
Contact person for scientific queries
Name 36476 0
Wendy Moyle
Address 36476 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 36476 0
Australia
Phone 36476 0
+61 (0) 7 3735 5526
Fax 36476 0
Email 36476 0
[email protected]

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.