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Trial registered on ANZCTR


Registration number
ACTRN12613000375752
Ethics application status
Approved
Date submitted
25/03/2013
Date registered
9/04/2013
Date last updated
10/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate and sustained effect of wearing gloves in combination with Traditional Thai Massage on alteration of skin temperature and hand mobility in scleroderma patients
Scientific title
Immediate and sustained effect of wearing gloves in combination with Traditional Thai Massage on alteration of skin temperature (thermography) and hand mobility in scleroderma patients
Secondary ID [1] 282175 0
None
Universal Trial Number (UTN)
U1111-1141-0177
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand deformity from sclerosis of the hand 288687 0
Condition category
Condition code
Inflammatory and Immune System 289039 289039 0 0
Connective tissue diseases
Alternative and Complementary Medicine 289068 289068 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants receive Traditional Thai Massage by a physiotherapist on one occasion only. Each upper extremity is massaged for 15 minutes. The left upper extremity is massaged first, followed by the right upper extremity. Participant’s left and right hands are randomised to one of two treatment options:

1. Massage on hand (with out glove) 15 minute, then thermography test and a nylon fabric glove is worn on the hand for a 10 minute, then remove glove for the last thermography test.

2. A nylon fabric glove is worn on the hand during the 15 minute massage (massage together with glove: control treatment) and remove glove for thermography test (hand thermal imager), then wearing glove back agian 10 minute, then remove glove for the last thermography test.

Massage started with left hand and continually go along side with right hand. All process take a time about 40-45 minute.
Intervention code [1] 286786 0
Treatment: Other
Comparator / control treatment
Control treatment: A nylon fabric glove is worn on the hand during the 15 minute Traditional Thai massage (group 2, mentioned above, which group is the control treatment) and then remove fore thermography test, then wearing glove again 10 minute, then remove fore thermography test.
Control group
Active

Outcomes
Primary outcome [1] 289152 0
Hand skin temperature
Timepoint [1] 289152 0
dorsum of the hand skin temperature (Thermography) at pre test (#1), after TTM immediately (#2), and after rest with wearing glove 10 minute (#3).
Secondary outcome [1] 301936 0
Hand mobility
Timepoint [1] 301936 0
Hand Mobility in Scleroderma (HAMIS) test at pre test (#1), and after rest with wearing glove 10 minute (#3).

Eligibility
Key inclusion criteria
Systemic sclerosis, diffuse subtype, Indurative phase
Minimum age
49 Years
Maximum age
62 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inflamatory phase and Atrophic phase, limited subtype

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)
Rheumatologist diagnosis. Block randomize allocation to grouping by draw lots in a black box in separately room, one by one. the patients did not know they grouping.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
patients walk in systemic sclerosis clinic, diagnosis, and Block randomize allocation to grouping.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculations base on statistical assumptions from Vannajak et al. (2013) provided a sample size calculation for mean comparison of two independent groups. participant is 28 persons. Because no evidence base of clinical assumptions, how diference hand skin temperature change is enough.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/11/2011
Actual
30/11/2011
Date of last participant enrolment
Anticipated
28/02/2012
Actual
28/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 4953 0
Thailand
State/province [1] 4953 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 286946 0
University
Name [1] 286946 0
The Research and Training Center for Enhancing Quality of Life of Working Age People.
Faculty of Nursing, Khon Kaen University, Thailand.
Country [1] 286946 0
Thailand
Primary sponsor type
University
Name
The Research and Training Center for Enhancing Quality of Life Faculty of Nursing, Khon Kaen University, Thailand. of Working Age People.
Address
Faculty of Nursing Khon Kaen University

123 Friendship Highway, Muang District

Khon Kaen 40002 Thailand
Country
Thailand
Secondary sponsor category [1] 285733 0
University
Name [1] 285733 0
Faculty of Graduated school
Khon Kaen University, Thailand.
Address [1] 285733 0
Faculty of Graduated school, Khon Kaen university
3rd Floor, Bimala Kalakicha Building, Khon Kaen University,
123 Friendship Highway, Muang District
Khon Kaen 40002 Thailand
Country [1] 285733 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288999 0
The office of human research ethics Khon Kaen Unversity
Ethics committee address [1] 288999 0
Ethics committee country [1] 288999 0
Thailand
Date submitted for ethics approval [1] 288999 0
26/08/2011
Approval date [1] 288999 0
28/11/2011
Ethics approval number [1] 288999 0
HE541337

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

Contacts
Principal investigator
Name 38726 0
Mr Kunavut Vannajak
Address 38726 0
Graduated school faculty, Khon Kaen university
Contact Address: 3rd Floor, Bimala Kalakicha Building, Khon
Kaen University,
123 Friendship Highway, Muang District
Khon Kaen 40002 Thailand
Country 38726 0
Thailand
Phone 38726 0
+66 043 083 9292611
Fax 38726 0
Email 38726 0
kvs_28@hotmail.com
Contact person for public queries
Name 38727 0
Yodchai Boonprakob
Address 38727 0
The Faculty of Associated Medical Sciences
Khon Kaen University
123 Moo 16 Mittapap Road
Nai-Muang, Muang District
Khon Kaen
40002, Thailand
Country 38727 0
Thailand
Phone 38727 0
+66 043 202399
Fax 38727 0
Email 38727 0
yodchai@kku.ac.th
Contact person for scientific queries
Name 38728 0
Ratanavadee Nanakara
Address 38728 0
Faculty of Medicine, Khon Kaen University
123 Mittraparp Highway, Muang District,
Khon Kaen 40002, Thailand
Country 38728 0
Thailand
Phone 38728 0
+66 043 348360-8
Fax 38728 0
Email 38728 0
ratanava@kku.ac.th

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.