| 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
|
|
|
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
|
|
|
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. |