| CTRI Number |
CTRI/2021/11/038103 [Registered on: 17/11/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of thoracic curvature and mobility in patients with upper back dysfunction in Computer desk workers |
|
Scientific Title of Study
|
Evaluation of Sagittal thoracic mobility and curvature in patients with upper back
dysfunction in computer desk worker |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVidhi Bhanushali |
| Designation |
PG Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9653657540 |
| Fax |
|
| Email |
vidhibhanushaliom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
mungikarphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidhi Bhanushali |
| Designation |
PG student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9653657540 |
| Fax |
|
| Email |
vidhibhanushaliom@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N 6 Cidco Aurangabad 431003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vidhi Bhanushali |
Department of Musculoskeletal Physiotherapy |
Department of Musculoskeletal Physiotherapy OPD no 1 MGM Institute of Physiotherapy N6 Cidco Aurangabad 431003
Aurangabad
MAHARASHTRA |
9653657540
vidhibhanushaliom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for Reasearch on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age from 18 – 55 years
Computer desk workers
Upper back pain ( NPRS 1 – 6 )
Works more than 7 hours a day
Persisent or recurrent thoracic pain from last 3 month
Pain produce on palpation of thoracic region |
|
| ExclusionCriteria |
| Details |
Individuals with radicular pain from cervical and
lumbar spine .
Inflammatory MSK disorder or infection ( TOS , T4
syndrome )
Spinal fracture or malignant disease ( Breast surgery )
Symptomatic angina pectoris
Previous thoracic spine operation ( Wedge fracture )
Operation with thoracotomy
Any Surgery of spine |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spinal Mouse |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale
Oswestry thoracic disability questionner |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/11/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Planed for Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objectives : To investigate the relationship between upper back pain with thoracic mobility and thoracic curvature . To investigate whether upper back pain have impact on functional disability . Design : Observational Cross sectional study
Study setting : MGM Institute of Physiotherapy , Aurangabad Participants : both male and female computer desk workers having upper back pain
Procedure : After ethical committee clearance , informed consent will be taken from the participants who fullfill the inclusion criteria for the study . A detailed assessment of subjects will be done . Assessment of upper back pain including pain intensity by NPRS , Oswestry thoracic disability questionner and then assessing thoracic mobility and thoracic curvature using spinal mouse
Outcome measures : NPRS , Oswestry thoracic disability questionner , Spinal mouse |