| CTRI Number |
CTRI/2015/06/005930 [Registered on: 19/06/2015] Trial Registered Prospectively |
| Last Modified On: |
18/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the differences between Indian and Chinese population in their standing posture |
|
Scientific Title of Study
|
Differences in spinal and pelvic postural parameters in two different racial groups, measured using Surface Topography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Mathew Cyriac |
| Designation |
Research Associate |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Department of Physiotherapy, Fr Muller Medical College Hospital, Kankanady, Mangalore - 575002, Karnataka
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9886638763 |
| Fax |
|
| Email |
arun.mathewpt@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Arun Mathew Cyriac |
| Designation |
Research Associate |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Department of Physiotherapy, Fr Muller Medical College Hospital, Kankanady, Mangalore - 575002, Karnataka
KARNATAKA 575002 India |
| Phone |
9886638763 |
| Fax |
|
| Email |
arun.mathewpt@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Arun Mathew Cyriac |
| Designation |
Research Associate |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Department of Physiotherapy, Fr Muller Medical College Hospital, Kankanady, Mangalore - 575002, Karnataka
KARNATAKA 575002 India |
| Phone |
9886638763 |
| Fax |
|
| Email |
arun.mathewpt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DIERS International GmbH
Dillenbergweg 4
D-65388 Schlangenbad, Germany |
|
|
Primary Sponsor
|
| Name |
Father Muller Research Centre |
| Address |
Father Muller Medical College, Kankanady, Mangalore - 575002
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arun Mathew Cyriac |
Father Muller Medical College |
Spinal and Posture Analysis Lab, Dept of Physiotherapy OPD, Ground Floor, FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE-575002 Dakshina Kannada KARNATAKA Dakshina Kannada KARNATAKA |
9886638763
arun.mathewpt@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic, young adults from students of Father Muller Medical College will be recruited for the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIERS Formetric 4DTM Raster-stereographic / Surface Topography system |
Surface Topography systems use the technique of Raster-stereography to analyze and estimate the sagital spinal and pelvic postural parameters. |
| Intervention |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
• Normal, Asymptomatic, healthy young adults of both genders.
• Members of the Malaysian - Chinese group should be the descendants of Chinese parents and grandparents on both maternal and paternal branches/lines
• 18 – 40 years of age
• Ability to give informed consent in English Language
|
|
| ExclusionCriteria |
| Details |
1. Degenerative disc disease with/without herniation
2. Mechanical Back pain (Facet joint syndrome, Muscular injury, Ligamentous injury etc)
3. Osteoarthritis of spine
4. Spondylolisthesis
5. Recent general surgery (past 12 months)
6. Spondylosis
7. Scoliotic deformity
8. Pregnancy
9. Metabolic diseases
10. Neoplasm
11. Congenital Deformities
12. Spinal Injuries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postural parameters obtained from the Formetric 4D Surface Topographic System |
Measured at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Pelvic Tilt
• Pelvic Torsion
• Pelvic Inclination
• Kyphotic Angle
• Lordotic Angle
• Surface Rotation
|
Measured at the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Need
of the study:
The sagittal plane contour of the spine plays an
important role in the normal function of the spine. Maintenance of the sagittal
spino-pelvic balance is found to be the result of combined effort of osteo-articular
and myo-fascial structures of the spinal column, the pelvis and the lower limb
muscles. A proper assessment of spinal posture can facilitate early detection
of postural aberrations and institution of adequate preventive and corrective
measures.1.2
Human population is subdivided into a plethora of
ethnic groups and races distributed worldwide. An ethnic group or ethnicity is a
socially defined category of people who identify
with each other based on common ancestral, social, cultural or
national experience3, whereas Race, as a social
concept, is a group of people who share similar and
distinct physical characteristics such as bone structure and skin, hair,
or eye color.4
Ethnicity plays an important role in the
differentiation of anthropometric values.5 Multiple studies have
been described in the literature that have analyzed the inter- ethnic
anthropometric and spinal postural parametric differences in humans as well as
in cadavers. 5 – 9 But based on these studies it is still unclear
whether or not race plays a role in the variability of pelvic morphology and
spino-pelvic anatomy.
Malaysia is a multi-racial country with
more than 70 identified ethnic groups. These ethnic groups are broadly
classified into four major groups namely Bumiputera (inclusive of Malay and
Indigenous), Chinese, Indians and Others (include non-Malaysian citizen). The
Chinese Malaysians are Malysian citizens of Han Chinese ancestry, descendents
of Han Chinese who arrived between the early and mid-20th century.
They constitute about 22.9 per cent of the entire Malaysian population.10
For the detection of changes in spinal posture, the
gold standard remains to be , the clinical examination along with radiological
techniques such as X Ray, CT and MRI until today. The radiation from these
diagnostic procedures leads to a very critical deployment for conducting
multiple examinations, particularly in young individuals. For this reason,
simple, but inaccurate and poorly reliable methods were developed for spinal
postural analysis like the kyphometer or the curve ruler. 11
A precise radiation free and inexpensive method for
detecting the spinal posture was then developed in early 1980’s, called Surface
Topography, based on the technology of Raster-stereography (RSG). The surface
contour analysis occurs from the projection of raster lines on the back of the
patient. Assignment of concave and convex areas to curved light patterns
enables automatic detection of anatomical landmarks. The system is able to
calculate a 3D model of the human spine, by means of certain anatomical fixed
points of the human body. Clinically relevant spinal and pelvic postural
parameters such as the trunk inclination, the kyphosis and the lordosis angles of
the spine can be determined by this technique. Thus surface topography offers
an alternative method of detecting spinal postural parameters because it is
side effect and contact-free, non invasive, fast and objective.11
The differences in spinal and pelvic postural
parameters in two different racial groups obtained using the non- invasive and
radiation free technology of Surface Topography haven’t been previously
analyzed. The aim of the present study is to describe the spinal and pelvic
postural parameters in a sample of healthy Chinese-origin Malaysian volunteers
and to compare with that obtained from an age matched healthy Indian
population. Our findings may provide greater insight into the influence of
ethnicity or racial differences in assessment of spinal posture as well as
management of spinal disorders. |