Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000437763
Ethics application status
Approved
Date submitted
7/04/2013
Date registered
17/04/2013
Date last updated
18/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The short term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients
Scientific title
The short term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients
Secondary ID [1] 282264 0
None
Universal Trial Number (UTN)
U1111-1141-5553
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand deformity from sclerosis of the hand 288790 0
Hand function limited by hand deformity 288791 0
Condition category
Condition code
Inflammatory and Immune System 289150 289150 0 0
Connective tissue diseases
Alternative and Complementary Medicine 289184 289184 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty-eight patients with SSc were random in to 2 group (14 persons per group).

Group 1, All participants receive Traditional Thai Massage by a relative, hand stretching exercise, and wearing glove more than 6 hour per day (the nylon glove is worn on both hands) in 2 weeks home program.

Group 2, All participants receive Traditional Thai Massage by a relative, and hand stretching exercise in 2 weeks home program. None gloving.

For both groups:
a) the duration and frequency of Traditional Thai Massage, 15 minute in each upper extremity and hand side, left and right; total 30 minute massage per day for 2 weeks; Massage by relative which trained by physiotherapist (single 30 minute session at baseline).
b) hand stretching exercise performd by patient (self care) after Traditional Thai Massage which trained by physiotherapist.
c) physiotherapist demonstrates hand stretching exercises at 30 min baseline session (Forearm pronation, Forearm supination, Wrist flexion, Wrist extension, Wrist radial/ulnar deviation, Finger abduction, Finger flexion, Finger extension, Thumb abduction/adduction and flexion/extension, Terminal pinch all finger opposite the thumb); participants then complete these stretches for 30 min once daily over 2 week period.

1.Perform everyday in 2 weeks, one session per day after receive Traditional Thai Massage.
2.Stretch to the end of the range of motion at a point of tightness, without inducing discomfort
3.Hold each stretch for 30 seconds
4.Complete 4 repetitions for each stretch on both sides.
5.Perform static stretching, that is avoiding ballistic, bouncing movement, with emphasis on muscle groups (joint) that have reduce ROM. Consequently, this was a strict precaution on hand in patients with SSc (The American College Sport Medicine [ACSM], 2006).
All patients were received example picture of stretching exercise procedure on hand and daily home program exercise was record in diary.

For group 1 the type of glove worn is nylon fabric glove, whether it is worn on both hands, and it is worn after Traditional Thai Massage, during the normal activity of daily living more than 6 hours per day, including the hand stretching exercises.

Superficial heating is also part of the home program. It is househood material, warm water or a hot pack, about 40 Celsius degree. Apply on hand before Traditional Thai Massage 15 minute.

All patients were received example picture of stretching exercise procedure on hand and daily home program exercise was record in diary and telephone visit (10 minute telephone call at 1 week in both groups.). Final test after 2 week patients will show a diary.
Intervention code [1] 286889 0
Rehabilitation
Intervention code [2] 286890 0
Treatment: Other
Comparator / control treatment
The group that does not wear the glove in combination with Traditional Thai Massage by a relative, undergo superficial hand heating, and hand stretching exercise in 2 weeks home program.
Control group
Active

Outcomes
Primary outcome [1] 289259 0
HAMIS is a performance index that consists of 9 items.
Assessing the hand movements include in an ordinary Range Of Motion test such as pronation and supination of the forearm, volar flexion and dorsal extension of the wrist, finger flexion and extension and thumb abduction.
It also evaluates the ability to make a thumb pincer grip and to make finger abduction. Each exercise is grade on 0-3 scales, where 0 corresponds to normal function and 3 determines that the patient is unable to perform the task.
In this study, each participant was sit in starting position and perform the test following by 9 items in HAMIS under the instruction of physical therapist.
Timepoint [1] 289259 0
2 weeks
Secondary outcome [1] 302182 0
nil
Timepoint [1] 302182 0
nil

Eligibility
Key inclusion criteria
Systemic sclerosis, diffuse subtype, Indurative phase
Minimum age
49 Years
Maximum age
55 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)
This study is a randomized control trial that was conducted with scleroderma (SSc) patients of the rheumatology department at Srinagarind Hospital, Khon Kaen University and carried out at the Faculty of Associated Medical Sciences, Khon Kaen University, Thailand.

Block randomized allocation to grouping by drawing lots in a black box in separate room, one by one.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation conducted by a lot.
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
Data of Hand mobility in scleroderma (HAMIS) test is expressed as a median: (Q1-Q3). Any significant difference between daily home program with glove group and daily home program group after two weeks of treatment was determined by using The Mann Whitney U test. The differences between the groups are significant at p-value<0.05.

Participants needed to achieve study objectives was determined by statistical assumptions supporting any sample size calculations by Vannajak et al., 2010.

full reference for Vannajak et al., 2010;
Vannajak K, Boonprakob Y, Nanagara R, Eungpinichpong W. The immediate and
short term effects of Traditional Thai Massage on alteration of skin temperature and hand mobility in Scleroderma patients. Thai Journal of Physical Therapy 2010: 32(2); 81-89.

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
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 4987 0
Thailand
State/province [1] 4987 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 287031 0
University
Name [1] 287031 0
The Research and Training Center for Enhancing Quality of Life of Working Age People. Faculty of Nursing, Khon Kaen University, Thailand.
Country [1] 287031 0
Thailand
Primary sponsor type
University
Name
Faculty of Graduated school Khon Kaen University, Thailand.
Address
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
Thailand
Secondary sponsor category [1] 285884 0
None
Name [1] 285884 0
Address [1] 285884 0
Country [1] 285884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289068 0
The office of human research ethics Khon Kaen Unversity
Ethics committee address [1] 289068 0
Ethics committee country [1] 289068 0
Thailand
Date submitted for ethics approval [1] 289068 0
26/08/2011
Approval date [1] 289068 0
28/11/2011
Ethics approval number [1] 289068 0
HE541337

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

Contacts
Principal investigator
Name 39074 0
Mr Kunavut Vannajak
Address 39074 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 39074 0
Thailand
Phone 39074 0
+66 043 083 9292611
Fax 39074 0
Email 39074 0
[email protected]
Contact person for public queries
Name 39075 0
Yodchai Boonprakob
Address 39075 0
The Faculty of Associated Medical Sciences Khon Kaen University 123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand
Country 39075 0
Thailand
Phone 39075 0
+66 043 202399
Fax 39075 0
Email 39075 0
[email protected]
Contact person for scientific queries
Name 39076 0
Ratanavadee Nanakara
Address 39076 0
Faculty of Medicine, Khon Kaen University 123 Mittraparp Highway, Muang District, Khon Kaen 40002, Thailand
Country 39076 0
Thailand
Phone 39076 0
+66 043 348360-8
Fax 39076 0
Email 39076 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

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