| CTRI Number |
CTRI/2023/10/058314 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of Neck and Upper Extremity pain with Fatigue and Hand Functions among Industrial workers |
|
Scientific Title of Study
|
Association of Neck and Upper Extremity Musculoskeletal Dysfunctions with Fatigue and Hand Function among Industrial workers: a cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Carvalho |
| Designation |
1st MPT (community physiotherapy) |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy, Ahmednagar |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil college of physiotherapy vilad ghat Ahmednagar MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
7588652260 |
| Fax |
|
| Email |
anjalicarvalho111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar |
| Address |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar |
| Address |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Physiotherapy Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar |
| Address |
DVVPFs COLLEGE OF PHYSIOTHERAPY opposite govt milk dairy MIDC vilad ghat Ahmednagar |
| 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 |
| Anjali Carvalho |
Industries |
Sainath udyog MIDC Ahmednagar 414111
Ahmadnagar
MAHARASHTRA |
7588652260
anjalicarvalho111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Industrial workers with neck and upper extremity pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with more than 2 years of work experience.
2. Workers doing fine activities of hand.
3. Participants working for at least 5 hours a day.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any neurological and orthopedic disorders.
2. Participants undergone recent neck or upper limb surgeries.
3. Participants whose task do not include neck or upper limb activities.
4. Participants with musculoskeletal dysfunctions other than neck and upper extremity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Nordic Musculoskeletal Questionnaire
2. Hand held Dynamometer
3. Sollerman Hand Function Test
4. Swedish Occupational Fatigue Inventory(SOFI) |
Immediately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
25/10/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In the industrial work environment, manual repetitive
tasks with non-ergonomic wrist and head positions are very common and result in
neck, shoulder and wrist pain. Considering
that work-related upper extremity dysfunction is a growing issue, showing high
prevalence, high costs, long term absenteeism and decreased
productivity in different economic sectors, it is necessary to develop studies
that analyze relevant factors for future preventive or therapeutic approaches
directed to specific population needs. |