Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000537550
Ethics application status
Approved
Date submitted
24/04/2015
Date registered
27/05/2015
Date last updated
27/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patient with low back pain: A randomized controlled trial
Scientific title
The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patient with low back pain: A randomized controlled trial
Secondary ID [1] 286573 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 294829 0
Condition category
Condition code
Musculoskeletal 295105 295105 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295349 295349 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 295350 295350 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients with low back pain in traditional Malay massage group (Group A) will be treated by one certified practitioner of traditional Malay massage, with the treatment being applied within 30 minutes in one session only on the area of pain in the lower back. The practitioner will follow the protocol of traditional Malay massage that has been provided for and approved by the Ministry of Health, Malaysia. The massage techniques involved in traditional Malay massage are fan stroking, basic kneading, thumb stroking, and static pressure.
Intervention code [1] 291688 0
Treatment: Other
Comparator / control treatment
The patients with low back pain in Group B (control) will undergo a relaxation treatment which patient will lying on plinth in supine position with both eyes closed for 30 minutes. No any massage provided during this technique.
Control group
Active

Outcomes
Primary outcome [1] 294885 0
The level of substance P in saliva and blood samples
Timepoint [1] 294885 0
The saliva and blood samples will be taken before (pre-treatment), and immediately after treatment (post-treatment)
Secondary outcome [1] 314283 0
The level of inflammatory mediators [i.e. TNF-alpha, IL-1beta, IL-8, monocyte chemotactic protein-1 (MCP-1), IL-6 and IL-10, and the soluble form of intercellular adhesion molecule (sICAM-1)] in both blood and saliva samples.
Timepoint [1] 314283 0
The saliva and blood samples will be taken pre- and post-treatment.
Secondary outcome [2] 314284 0
Pain intensity will be measured using Visual Analogue Scale (VAS)
Timepoint [2] 314284 0
VAS will be measured pre- and post-treatment
Secondary outcome [3] 314285 0
The Rolland-Morris Low Back Pain and Disability Questionnaire (RMDQ) which is used to assess the level of disability associated with low back pain.
Timepoint [3] 314285 0
The RMDQ will be taken during pre-treatment and one day after treatment.

Eligibility
Key inclusion criteria
1. Age between 20 to 40 years old
2. Non-specific low back pain more than or equal to 4 weeks
3. Pain scale (VAS) is greater than or equal to 4
4. Body mass index (BMI) are between greater than or equal to 18.5 kg/m2 to less than or equal to 29.9 kg/m2
5. Willingness to participate in this study
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nerve involvement or compression
2. Spinal disorders (e.g. spondylolisthesis, herniated nucleus
pulposus, spondylosis, spinal fracture, back surgery)
3. Neurological deficit (e.g. multiple sclerosis, hemi/ paraparesis
or myelopathy)
4. Infectious diseases (e.gs skin problem)
5. Menstruation during research, pregnancy, smokers and
febrile
6. Receive any low back pain medication and seek any
treatment for low back pain.

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)
Low back pain patients attending the Physiotherapy Clinic, Universiti Teknologi MARA (UiTM), Malaysia, who fulfill the inclusion criteria will be screened by a Physiotherapist and Orthopedic specialist and will be invited to participate into this study. For those who has one or more than one of the exclusion criteria will be excluded in this study.

Explanatory statement will be given to those eligible participants and written informed consent will be obtained before the commencement of the study. Consenting participants will then be randomly allocated using a simple random sampling method into the 2 groups:

(i) traditional Malay massage (Group A) or
(ii) control groups (Group B)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed envelopes which is pick-up one of the two sealed envelopes. These envelopes containing group division.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation:
The sample size is calculated using PS power and sample size calculation software. The standard deviation 46.15 and means 23.42 are taken from the result data of substance P level in saliva samples based on previous study conducted by Mackawan et al. Accordingly, we will need to study 53 subjects to be able to reject the null hypothesis that this response difference is zero with a power of 0.95. The Type I error probability associated with this test of this null hypothesis is 0.05. To account for 20 percent dropout, a total of 64 subjects is required.

Data analysis:
The recorded data will be analyzed using SPSS Version 20.0 and it will be explained further later. Data from participants will be entered into a computerized database and analyzed using the SPSS software version 20.0. Mean, standard deviation, and range will be calculated for each variable. Data will be checked for normal distribution in terms of skewness and kurtosis, normality test, univariate outliers and missing data. Paired t-test will be used to measure the differences of pre- and post-intervention within groups for every outcome measure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
Date of last participant enrolment
Anticipated
30/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 6840 0
Malaysia
State/province [1] 6840 0
Selangor

Funding & Sponsors
Funding source category [1] 291149 0
University
Name [1] 291149 0
Research Acculturation Grant Scheme (RAGS), Universiti Teknologi MARA (UiTM)
Country [1] 291149 0
Malaysia
Primary sponsor type
Individual
Name
Dr. Long Chiau Ming
Address
Faculty of Pharmacy,
Level 11, FF1,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam, Selangor,
Malaysia.
Country
Malaysia
Secondary sponsor category [1] 289828 0
None
Name [1] 289828 0
Address [1] 289828 0
Country [1] 289828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292726 0
Research Ethics Committe UiTM
Ethics committee address [1] 292726 0
Ethics committee country [1] 292726 0
Malaysia
Date submitted for ethics approval [1] 292726 0
18/11/2014
Approval date [1] 292726 0
24/11/2014
Ethics approval number [1] 292726 0
600-RMI (5/1/6)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 416 416 0 0
/AnzctrAttachments/368411-Figure 1.docx
Attachments [2] 417 417 0 0
/AnzctrAttachments/368411-Table 1 (outcome measure).docx
Attachments [3] 418 418 0 0
/AnzctrAttachments/368411-DR LONG CHIAU MING.pdf

Contacts
Principal investigator
Name 56702 0
Dr Dr. Long Chiau Ming
Address 56702 0
Faculty of Pharmacy
Level 11, FF 1 ,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam,
Selangor, Malaysia.
Country 56702 0
Malaysia
Phone 56702 0
+6012-4778468
Fax 56702 0
Email 56702 0
[email protected]
Contact person for public queries
Name 56703 0
Nurhanisah Binti Sejari
Address 56703 0
Postgraduate Lounge & Workstation,
Level 6, FSK 1,5,
Faculty of Health Sciences,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam,
Selangor, Malaysia
Country 56703 0
Malaysia
Phone 56703 0
+6017-7797362
Fax 56703 0
Email 56703 0
[email protected]
Contact person for scientific queries
Name 56704 0
Dr.Long Chiau Ming
Address 56704 0
Faculty of Pharmacy
Level 11, FF 1 ,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam,
Selangor, Malaysia.
Country 56704 0
Malaysia
Phone 56704 0
+6012-4778468
Fax 56704 0
Email 56704 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
SourceTitleYear of PublicationDOI
EmbaseThe immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patients with low back pain: Study protocol of a randomised controlled trial.2016https://dx.doi.org/10.1186/s12906-016-0988-1
N.B. These documents automatically identified may not have been verified by the study sponsor.