| CTRI Number |
CTRI/2024/04/066573 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of ergonomic work station and neck exercises on Tailors, for work posture. |
|
Scientific Title of Study
|
Additional effects of Ergonomic Modifications along with Cervical Stabilization Exercises for work posture, neck pain, disability and activity limitation in Tailors with neck pain-A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariya Saeed |
| Designation |
Post graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy, Department of Community Physiotherapy 11/12,Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8698314000 |
| Fax |
|
| Email |
mariya.a.saeed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy, Department of Community Physiotherapy, 11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy, Department of Community Physiotherapy,11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005
MAHARASHTRA
|
| 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 |
| Mariya Saeed |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy, Department of Community Physiotherapy,11/12, Thube Park, Shivaji Nagar,Pune-
411005
Pune
MAHARASHTRA |
8698314000
mariya.a.saeed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tailors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cervical Stabilization Exercises |
The subject will be instructed to perform axial extension by activating the deep neck flexors and then to neutral spine position with a 10-second hold performed for 3 sets of 10 repetitions each.
The exercises will include,
1. Shoulder flexion from 0 to 90 degrees.
2. Shoulder abduction from 0 to 90 degrees.
13
3. Shoulder external rotation with arms at the side.
Sessions will be taken for 4 weeks-3 days/week.
|
| Intervention |
Ergonomic Modifications |
Changing the height of the work surface according to the anthropometric dimensions (height) of the employee such that the neck position is less than 20 degrees of flexion, so that the height of the workstation is 4 inches above the elbow level.(Approximately below the nipple level).Sessions will be taken for 4 weeks-3 days/week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Work experience greater than equal to 1 year
2)Chronic neck pain greater than 3 months
3)At Least 8 hours of work per day for 5 days per week
4)Numerical Pain Rating Scale greater than equal to 3
5)Rapid Upper Limb Assessment greater than 3 |
|
| ExclusionCriteria |
| Details |
1. Recent Major trauma or fracture of cervical spine, history of surgery of cervical spine.
2.Any congenital or acquired deformity.(eg: Torticollis)
3. Radiculopathy, spondylolisthesis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rapid Upper Limb Assessment |
At baseline (0 weeks) & after intervention (after 4
weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.Cranio-cervical Flexion Test
3.Numerical Pain Rating Scale
4.Patient Specific Functional Scale
5.Neck Disability Index |
At baseline (0 weeks) & after intervention (after 4
weeks) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The work of tailors is highly labour intensive, most of the tasks are performed manually. The prevalence of neck pain is 91% among tailors .The job of tailors requires them to continuously look down for an extended period, this results in incorrect postures and disturbed biomechanics. Poor work layout leads to musculoskeletal disorders (MSDs). Thus implementation of ergonomic principles in tailors is necessary. The traditional way of working has become obsolete, so the ergonomic design of workstations should be introduced to prevent occupational disease.
Null Hypothesis: There will be no significant effect of ergonomic modifications along with cervical stabilization exercises on neck pain, work posture, activity limitation, and disability in tailors. Alternate Hypothesis: There will be a significant effect of ergonomic modifications along with cervical stabilization exercises on neck pain, work posture, activity limitation, and disability in tailors. |