| CTRI Number |
CTRI/2025/07/090819 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A Study to see the effect of upper back brace with auditory feedback on posture and chronic neck pain |
|
Scientific Title of Study
|
Effect of an modified upper back brace with auditory feedback for postural
correction and chronic neck pain relief in office workers: A pre-post study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Sadashankar Tiwari |
| Designation |
Post graduate student in occupational therapy |
| Affiliation |
OT training school and centre LTMMC and GH Sion |
| Address |
Lokmanya tilak hospital RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022
RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
08104748398 |
| Fax |
|
| Email |
sakshisadatiwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Sadashankar Tiwari |
| Designation |
Post graduate student in occupational therapy |
| Affiliation |
OT training school and centre LTMMC and GH Sion |
| Address |
Lokmanya tilak hospital RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022
RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
08104748398 |
| Fax |
|
| Email |
otrashmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Sadashankar Tiwari |
| Designation |
Post graduate student in occupational therapy |
| Affiliation |
OT training school and centre LTMMC and GH Sion |
| Address |
Lokmanya tilak hospital RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022
RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
08104748398 |
| Fax |
|
| Email |
sakshisadatiwari@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Training school and centre LTMMC and GH sion RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022 |
|
|
Primary Sponsor
|
| Name |
OT Training school and centre LTMMC and GH sion |
| Address |
RB2 Central Railway Quarters, Sion East, Sion, Mumbai, Maharashtra 400022 |
| Type of Sponsor |
Government 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 |
| DrSakshi Sadashankar Tiwari |
OT training school and centre LTMMC and GH Sion |
Occupational therapy depatrment 5th floor RB2 Central Railway Quaters,Sion East,Sion,Mumbai,Maharasthra 400022
Mumbai
MAHARASHTRA |
08104748398
sakshisadatiwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH Lokmanya Tilak Municipal Medical College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BMC Office Worker
Individual working in desk based jobs for at least 6 hours per day
Neck pain severity ,based on neck disability index range from moderate (15) to severe (35)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified upper back brace with auditory feedback |
Intervention protocol will comprise of 4 week
The subject also given demonstration of the stretching and
strengthening exercises
Subject will follow up twice a week
Session will be of 45 min
1 minute break between each exercise
pateint has to wear upper back brace for 8 hours |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Both |
| Details |
Individuals working in desk-based jobs for at least 6 hours per day
Neck pain severity, based on the neck disability index range from moderate(15) to severe greater than (35)
Positive shoulder Girdle flexibility tes |
|
| ExclusionCriteria |
| Details |
history of cervical spine surgery , scoliosis,severe kyphosis ,or other
spinal deformities
Chronic condition affecting posture : rheumatoid arthritis or ankylosing
spondylitis
History of neurological disorders ( stroke , multiple sclerosis or parkinson
disease
Individual received any postural correction therapy, or physiotherapy in
the past 3months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| modified upper back brace correct posture and reduce chronic neck pain |
8week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
25/07/2025 |
| 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="1"
Months="5"
Days="7" |
|
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
|
Forward Head Posture is a postural deformity where the head is positioned anterior to the vertical midline of the body. It is typically characterized by excessive extension of the upper cervical spine and flexion of the lower cervical and upper thoracic spine. This posture often results from prolonged poor ergonomics or habitual slouching and places increased strain on the cervical spine and surrounding musculature. Rounded Shoulder Posture refers to a condition where the shoulders are positioned forward of the midline of the body. This is commonly associated with internal rotation of the humerus and protraction of the scapulae. It often accompanies forward head posture and is linked to muscular imbalances such as tight pectoralis major/minor and weak scapular stabilizers like the rhomboids and lower trapezius.Office workers are employees whose primary job responsibilities are performed in an office environment ,typically involving adminitrative ,clerical, managerial, or technical task that require the use of computers, communication tool,and paperwork .These postural deviations place excessive strain on the cervical and upper thoracic spine, often leading to chronic neck pain (CNP), muscular imbalances, and reduced functional efficiency. chronic neck pain refers to neck pain that persists for 12 weeks or more despite treatment Studies have shown that poor posture contributes to musculoskeletal disorders, negatively affecting productivity and overall well-being Conventional interventions such as ergonomic adjustments, posture training, and physical therapy are commonly used to address FHP and RSP. However, compliance with posture correction strategies remains a challenge Wearable devices, including back braces, have been explored as a means to provide external support, but their passive nature may lead to muscle dependence rather than long-term correction.Recent advancements in biofeedback technology have introduced auditory feedback mechanisms that help users develop self awareness and active postural correction. By integrating auditory cues, an upper back brace may encourage sustained posture improvements without fostering reliance on external support. However, research on the effectiveness of such a device in office workers with chronic neck pain is still limited.A study is already been done in the department “ effect of upper back brace with auditory feedback for forward head rounded shoulder posture among office worker with chronic neck pain – A pre-post single group study” by Jyotsna Rupesh Bankhele et al The study showed the significant improvement in forward head and rounded shoulder as well as reduction in neck pain . however, it was conducted over a short period with small sample size. Therefore, we now aim to replicate the study with larger population over an extended period |