| CTRI Number |
CTRI/2024/09/073974 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of scapular position and neck pain in bus drivers- A correlational study |
|
Scientific Title of Study
|
Correlation of scapular position and neck pain in bus drivers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vyas Dipsha Rupeshbhai |
| Designation |
Post Graduate |
| Affiliation |
Ahmedabad Institute Of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060
Ahmadabad GUJARAT 380060 India |
| Phone |
8160822036 |
| Fax |
|
| Email |
vyasdipsha141@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Alpa Purohit |
| Designation |
Vice Principle,PhD, PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060
Ahmadabad GUJARAT 380060 India |
| Phone |
9313966648 |
| Fax |
|
| Email |
dralpaphysio@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Alpa Purohit |
| Designation |
Vice Principle,PhD, PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060
Ahmadabad GUJARAT 380060 India |
| Phone |
9313966648 |
| Fax |
|
| Email |
dralpaphysio@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060 |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Institute Of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060 |
| 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 |
| Dr Alpa Purohit |
Ahmedabad Institute of Medical Sciences |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060 Ahmadabad GUJARAT |
9313966648
dralpaphysio@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research And Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bus drivers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Bus drivers have at least 3 years of work experience.
Duration of driving is more than 5 hours.
Drivers, who have neck pain
VAS score should be between 3 to 7. |
|
| ExclusionCriteria |
| Details |
Individual with congenital deformities.
Individual with severe neurological problems.
History of surgery around shoulder and neck.
Recent history of trauma around neck and shoulder.
Drivers drive electrical bus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified lateral scapular slide test [MLSST] |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale [VAS] |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need of the study Driving occupation requires the most usage of neck and shoulder areas. Therefore, the overuse and improper support of muscle in this region can have an impact in more ways than one. Also, driving requires prolonged sitting and rapid hand movements while operating steering wheel. Therefore, it may cause pain in upper back area, which may affect scapular posture. As a result, maintaining improper posture for prolonged period of time can lead to muscular imbalance. Thus, it may lead to alter scapular alignment, which may cause altered scapular motion. Additionally, abnormal posture causes forward head and rounded shoulder with neck pain due to muscle imbalance between curvature of spine and muscle that are attached to neck bone. There is dearth of literature with regards to scapular position correlate with neck pain among drivers, which becomes significant of such a research work, because an altered alignment of the posture can lead to undue strain on the skeletal and soft tissue structure lead to an imbalance muscle performance. So, here the need arises to check the correlation of scapular position and neck pain in bus drivers becomes extremely crucial if these problems are to be dealt with efficiently.
Aim To determine whether the scapular position and neck pain are correlated in bus drivers.
Objective To measure scapular position using modified lateral scapular slide test To assess the neck pain To find out correlation of scapular position and neck pain in bus drivers.
Procedure
All subjects would be screened as per inclusion and exclusion criteria and those who are appropriate to the study would be chosen. • Written inform consent form will be signed by subjects who will be included in study.
Demographic information including age, mass, height, dominance of the hand and body mass index (BMI) will be measured
VAS : VAS is measured in four different positions of hand. (1) Hands on its rest position. (2) Hands on hip. (3) Hands in 90-degree abduction (4) Hands in 120 degree abduction.
Modified lateral scapular slide test would be used in clinical settings to assess medio-lateral inferior angle displacement and scapular asymmetry at four different degrees of shoulder abduction.
A digital Vernier caliper and 1kg dumbbell-like weights will be used. The scapular examination should largely be accomplished from the posterior aspect. The scapula should be exposed for complete visualisation. This can be done by removing the shirt. For identification of T7 vertebrae:- This starts by identifying the spinous process of the 7th cervical vertebra (C7). After identifying C7, palpate the spinous processes of the vertebrae down to T7 and then mark it with a tag or marker pen. Then, measure the distance between the inferior angle of the scapulae and the spinous process of T7 in 4 different arm positions. The first position is with the arms by the side. The second is with the subject’s hands on the hips, and the third is with the arms elevated to 90º of shoulder abduction with 1kg load hold in their hands. The fourth position is 120° of shoulder abduction with 1kg load hold in hands.
Distance from the inferior angle of the scapula to the spinous process of the thoracic vertebrae in the same horizontal plane will be measured in all positions. If the distance is greater than 1.5cm, the test is positive
All measurements will be captured bilaterally in less than 60 seconds. Subjects will be given as much rest time between measurements as they required. No more than 30 seconds will be generally necessary. The caliper will set to zero by an after each measurement. |