| CTRI Number |
CTRI/2018/10/016112 [Registered on: 23/10/2018] Trial Registered Prospectively |
| Last Modified On: |
10/10/2018 |
| 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
|
ERGONOMICS ON WORK RELATED MUSCULO SKELETAL DISORDERS AMONG DENTAL PRACTITIONERS |
|
Scientific Title of Study
|
EFFECTIVENESS OF PHYSIOTHERAPY BASED ERGONOMICS AND POSTURAL CORRECTION ON MANAGEMENT OF WORK RELATED MUSCULOSKELETAL DISORDERS AMONG DENTAL PRACTITIONERS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NDAHIRIWE Chance Christian |
| Designation |
PG Students |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram (DT)
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
chriseds2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayyappan Jayavel |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
203, D- Block,
Medical Staff quarters,
SRM IST
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9994948597 |
| Fax |
|
| Email |
ayyappanpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayyappan Jayavel |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
203, D- Block,
Medical Staff quarters,
SRM IST
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9994948597 |
| Fax |
|
| Email |
ayyappanpt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayyappan |
| Address |
203, Medical Staff quarters,
D- Block,
SRM IST
Kattankulathur |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| AyyappanJ |
Department of Physiotherapy |
Room No:116
SRM Medical College Hospital and Research Center
Potheri,
Kattankulathur
Kancheepuram (DT)
Kancheepuram
TAMIL NADU |
9994948597
ayyappanpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculo Skeletal Disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical activity of their choice |
30 min of physical activity of their choice for three days per week for 8 weeks |
| Intervention |
Postural Control Exercise and ergonomic education |
3 times per week of Postrual control exercise and ergonomic education |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Any dental practioner who reported WRMSDs including Dentists, Dental hygienists,PG students, Practiced for more than 6 months, All should score 3 and above on REBA |
|
| ExclusionCriteria |
| Details |
Those without MSDs
UG students
Those already on medications for more than 1 month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rapid Entire Body Assessment
Rolland Morris Disability Index
|
Before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rapid Entire Body Assessment
Rolland Morris Disability Index
Upper Extremity Function Index
Neck Disability Index
|
Before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/10/2018 |
| 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="0"
Months="3"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All participants meeting criteria of participation will sign informed consent.15 participant will be in the exposed group will be the ones receiving Postural correction exercises and ergonomics education. The remaining 15 will be given stretching exercises by giving them an app reminder for stretching (Workout alert) SCREENING OF THE PARTICIPANTS REBA Employee Assessment worksheet will be used to assess the risk to development or worsening of MSDs before and after. This assessment will be as a baseline of assessing improvement in posture different pictures will be taken in different angles of the participants, therefore ergonomics classification will be done to determine the risk level and ergonomics education awareness Intervention group will be performing the average 3 sessions of postural control exercises instructions and ergonomics education per week for at least twice per weeks. The serial filling of data collection tools to track trends of improvements will be done once at the start and after every 2 weeks. Guideline protocols for exercises will be demonstrated prior, Optimal good posture in different tasks in dentistry and exercises will be given. Guidelines are UCLA Ergonomics exercises protocol and POSTURITE Protocol exercises. The control group will be performing general guidelines of recommended physical activity of their choice for 30 minutes thrice per week at least during the data collection. The same follow up will be done as it is in the experimental group. Three times follow up screening will be givem with adjustment in education and demonstrations. |