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CTRI Number  CTRI/2024/03/064774 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2026
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   Detailed risk evaluation for back pain in dentist and results of new posture feedback device along with physiotherapy exercise as treatment to reduce pain and enhance physical function in dentist having back pain 
Scientific Title of Study   Comprehensive risk factor analysis and effect of novel postural correction intervention on physical function in dentists with mechanical spine pain -A mixed method 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  Victoria Kuttan 
Designation  PhD Scholar Assistant Professor 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  Department of Physiotherapy Integrated OPD 1st Floor room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India
Plot 1 and 2 Sector 1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  victoriak@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bela Agarwal 
Designation  Head of Department Cardiovascular and Respiratory Physiotherapy 
Affiliation  MGM Institute of Health Sciences MGM School of Physiotherapy 
Address  Department of Physiotherapy Integrated OPD, 1st Floor room no-115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Bela Agarwal 
Designation  Head of Department Cardiovascular and Respiratory Physiotherapy 
Affiliation  MGM Institute of Health Sciences MGM School of Physiotherapy 
Address  Department of Physiotherapy Integrated OPD, 1st Floor room no-115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai 
 
Primary Sponsor  
Name  Victoria Kuttan MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM Educational Campus Department of Physiotherapy Integrated OPD, 1st Floor room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Victoria Kuttan   MGM Institute of Health Sciences MGM School of Physiotherapy  Department of Physiotherapy, Integrated OPD 1st Floor, room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA 
02227437866

victoriak@mgmsopnm.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committe for Research on Human Subjects MGM INSTITUTE OF HEALTH SCIENCES NAVI MUMBAI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dentists 
Patients  (1) ICD-10 Condition: M549||Dorsalgia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy group Group B  The participants in the conventional group will receive conventional physiotherapy exercise. The conventional physiotherapy exercise will be administered 4 times /week for 12 weeks One supervised session and three telemetric sessions (through online platform)of including 20-30 minutes exercises with rest breaks of 30 second between each exercise and 10 minutes of cognitive behavioral therapy. Physiotherapy intervention includes – warm up, stretching, strengthening and sensorimotor training and cognitive behavioral therapy cool down. Ergonomic advice manual will be shared with the participants and an education session will be held once a month for 3 months for both the groups  
Intervention  Novel device and Conventional Physiotherapy Group A  The participants in the experimental group will be given the novel postural correction device to be used during work hours for at least 3 to 4 hours a day 3 to 5 days a week for 12 weeks along with conventional physiotherapy exercise 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Dentists registered under Dental Council of India and practicing dentistry
Male and female in the age group of 23 to 50 years
Dentist with mechanical spine pain
Dentist who are willing to participate in the study
 
 
ExclusionCriteria 
Details  Dentists with VAS Score more than 7 at time of evaluation who are experiencing pain while performing the physical function
Dentists having any known disorder of the musculoskeletal disorder such as Rheumatoid Arthritis, Ankylosing Spondylitis and others systemic disease affecting the musculoskeletal system.
Severe uncontrolled cardiopulmonary disorder’s or conditions, neurological conditions (in whom test performance is not possible) and psychological disorders unable to comprehend instructions.
Dentists having history of traumatic injury to the upper quadrant and low back
Dentists with history of surgery to spine, upper extremity joints in the past one year
Dentist who are pregnant
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Designed Survey tool will be administered to measure intrinsic and extrinsic risk factors
Two dimensional and three dimensional Kinematics of dental posture for different
Muscle activity (Fatigue of neck upper back , low back muscles)
Postural angle of the spine
Posture analyis using RULA
Pain using Visual Analogue scale and
Back core muscle strength
Muscle flexibility
Joint position sense measurement
Manual dexterity
Hand function

 
Cross sectional study – Baseline

Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks



 
 
Secondary Outcome  
Outcome  TimePoints 
Modiefied Oswestry Scale(MODQ)
Neck Disability Index(NDI)
Disability of arm shoulder and arm (DASH)
 
Cross sectional study – Baseline

Experimental study baseline, 4 weeks , 8 weeks and 12 weeks
 
 
Target Sample Size   Total Sample Size="354"
Sample Size from India="354" 
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
Modification(s)  
N/A 
Date of First Enrollment (India)   01/04/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 present mixed method, study participants will be included as per the inclusion and exclusion criteria. The cross-sectional part of the study aims to study the comprehensive intrinsic and extrinsic risk factors for developing mechanical spine using a survey tool and clinical tests to assess pain, posture and physical function in 354 dentists. A survey tool will be formulated using the Delphi method and then tested for validity and reliability. 60 dentists a subset of the 354 dentists (30 with and without mechanical spine pain) will be analysed biomechanics for different operatory procedures.

A novel postural device will be developed based on focus group discussions with electronic engineers and dentists with various specialties and pilot tested with 10 dentists without mechanical spine pain to provide real-time kinesthetic awareness. The device development will be as per the steps for medical device innovation.

 

The experimental hypothesis is that Novel posture correction device and conventional physiotherapy intervention will be more effective in reducing pain and improving physical function compared to conventional physiotherapy intervention in dentists with mechanical spine pain.

 

The experimental part of the study a total of 72 dentists with mechanical spine will be participating. The participants will be randomly allocated into experimental and conventional group using computed generated random number tables and allocation will be concealed using Sequentially numbered opaque sealed envelope(SNOSE). The participants in the experimental group will be given the novel postural correction device to be used during work hours for at least 3-4 hours a day, 3-5 days a week for 12 weeks along with conventional physiotherapy exercise. The participants in the conventional group will receive conventional physiotherapy exercise. The conventional physiotherapy exercise will be administered 4 times /week for 12 weeks

One supervised session and three telemetric sessions (through online platform)of including 20-30 minutes exercises with rest breaks of 30 second between each exercise and 10 minutes of cognitive behavioral therapy. Physiotherapy intervention includes – warm up, stretching, strengthening and sensorimotor training and cognitive behavioral therapy cool down. Ergonomic advice manual will be shared with the participants and an education session will be held once a month for 3 months for both the groups.

Participants will be analysed for all the outcome measure for pain, posture and physical function at baseline, 4 weeks, 8 weeks and 12 weeks of clinical test.

Data of the experimental group will be statistical analysed within and between the groups.

The result of the study will help in developing an algorithm for risk factor stratification and early identification of mechanical spine pain in dentists. Intervention - will benefit in reducing pain and improving physical function. A guideline booklet will be formulated will the help of study findings which would include all the ergonomic advises and exercises specific to task for the dentists community.

 
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