| CTRI Number |
CTRI/2023/08/056481 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of Neck Angle with arches of back and Pelvic angle in healthy Young Adults |
|
Scientific Title of Study
|
Correlation of Craniovertebral Angle with Thoracic Kyphosis, Lumbar Lordosis and Pelvic Tilt in Asymptomatic Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsna Thosar |
| Designation |
Associate Professor |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai Mumbai MAHARASHTRA 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
jyotsnathosar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsna Thosar |
| Designation |
Associate Professor |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai Mumbai MAHARASHTRA 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
jyotsnathosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sheetal Kokane |
| Designation |
PG student |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07738865741 |
| Fax |
|
| Email |
sheetalkokane27@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and centre, Seth GS Medical college and KEM hospital,Parel, Mumbai -12 |
|
|
Primary Sponsor
|
| Name |
Jyotsna Thosar |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai Mumbai MAHARASHTRA 400012 India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jyotsna Thosar |
P.T. School and centre, Seth GS Medical college and KEM hospital |
Hand OPD , 402, GROUND FLOOR PHYSIOTHERAPY DEPARTMENT,SETH GS medical College
Mumbai
MAHARASHTRA |
9821066016
jyotsnathosar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Age18-25years, 2.Male & female, 3.Individuals willing to participate |
|
| ExclusionCriteria |
| Details |
1.Recent history of neck pain,back pain & spine surgery,2.Any congenital spinal deformity,3.Presence of functional and structural scoliosis, 4.Presence of any neurological disorder. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Craniovertebral angle using photogrammetry method using MB-ruler software.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2023 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The human spine is a biomechanical masterpiece, enabling bipedalism through unique
skeletal alterations and resulting in the “S-shape” spinal curvature. In the last couple of years
screen time was increased significantly. Maintaining the same posture for long periods of
time is risk factor to change the normal alignment of spine. With technological advances, the
use of digital devices such as smartphones, tablets and notebooks has risen dramatically. In
addition, the expansion of internet networks and their vast domains of applications has
notably augmented the average time spent using these technologies. This has led to
musculoskeletal impairments in the neck and shoulder regions. Apart from educational work,
adults are also using mobile phones and tablets for their leisure time activities e.g. - novel
reading, playing games, digital artworks etc. Young adults are maintaining static posture of
cervical flexion for longer period of time during attending lectures, seminars and while doing
writing work for writing assignments, notes & during exams. Due to this, there are some
compensatory changes which affect cervical spine. It leads to changes in thoracic and lumbar
spine as well as pelvis to maintain the spinal balance. Sagittal malalignment plays a
respectable role in multiple spinal pathologies and therefore the benefit of analysing sagittal
alignment is not only limited to patients having deformity and its equally important in
asymptomatic population too.There was paucity of literature regarding midline alignment
correlation in asymptomatic young adults. Hence, in this study 50 asymptomatic young adults
in the age group of 18-25 was recruited according to the inclusion and exclusion criteria &
their midline alignment was assessed. For cervical spine craniovertebral angle was measured
by photography method and by using MB-ruler software. Thoracic kyphosis & lumbar
lordosis was assessed using flexicurve and indices was calculated by using MB-ruler
software. Pelvic tilt was assessed by self designed pelvic inclinometer. Correlation of
craniovertebral angle is done with thoracic kyphosis, lumbar lordosis and pelvic tilt.
58
Data for statistical analysis was entered using MS-Excel (version 2016). Statistical analysis
was performed using SPSS (version 25) software and Minitab (version 19) software.
Normality was checked by Kolmogorov-Smirnov test. Thoracic kyphotic index and right
pelvic tilt did not pass the test of normality; Hence Spearman correlation test was used to
measure correlation coefficient. Lumbar lordotic index and left pelvic tilt passed the test of
normality; Hence Pearson correlation test was used to measure correlation coefficient.
Results was calculated using scatter diagram and tables. Results showed that when CVA is
correlated with thoracic kyphosis index, lumbar lordosis index and pelvic tilt angles; it has
weak negative correlation with all of the parameters. P value for all correlation was greater
than 0.05. Hence, Study concluded that craniovertebral angle does not have significant
correlation with thoracic kyphosis, lumbar lordosis and pelvic tilt angles. |