| CTRI Number |
CTRI/2021/09/036372 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of exercises on pain, disability and job satisfaction on neck pain in desk job employees working from home. |
|
Scientific Title of Study
|
Effects of exercise intervention on pain, disability and job satisfaction on mechanical neck pain in desk job employees working from home: A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gowda Suyogini Manjappa |
| Designation |
Post Graduate Student- Masters in Community Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Physiotherapy department, 1st floor, 1st cabin, thube park, shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8369794441 |
| Fax |
|
| Email |
akshatagowda96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Associate Professor, Department of Community Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Physiotherapy department, 1st floor, 1st cabin, Thube park, shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Associate Professor, Department of Community Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Physiotherapy department, 1st floor, 1st cabin, Thube park, shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy,Thube Park, shivajinagar, Pune. |
| 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 |
| Suyogini Gowda |
Sancheti Institute College of Physiotherapy |
Sancheti Institute College of Physiotherapy, physiotherapy department, 1st floor, 1st cabin, Thube park, shivajinagar, Pune.
Pune
MAHARASHTRA |
8369794441
akshatagowda96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopaedic and Rehabilitation Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Education program (control) |
Educational pamphlet |
| Intervention |
Exercise Intervention |
40 minutes a day, 3 days a week, 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Employees working from home from last 6 months, use of computers/laptop, working minimum 5hours/day, employees with mechanical neck pain for more than 3 months, provoked pain on following two test: (1) single movement of active flexion of neck or extension with retraction of neck, and (2) sustained flexion, extension with retraction or rotation of the neck for a maximum of 2 minutes.
|
|
| ExclusionCriteria |
| Details |
Employees suffering from musculoskeletal related condition such as RA (Rheumatoid arthritis) and other connective tissue disorders, having cervical fracture, having previous surgery of upper limb in last 6 months, abnormal neurological signs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Orebro musculoskeletal pain questionnaire, Neck disability index |
Baseline and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fear avoidance belief questionnaire, Utrecht work engagement scale. |
Baseline and 4th week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/07/2022 |
|
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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this research study is to examine the impact of exercise on mechanical neck pain, the level of disability associated with it and job satisfaction in desk job employees using computers/laptops working from home. This may help understand the benefits of the exercises on mechanical neck pain for the employees while working from home. |