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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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