| CTRI Number |
CTRI/2024/10/075217 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| 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
|
To compare the effect of scapula posture correction with neural flossing versus coventional exercises in cervical radiculopathy in dental professionals with cervical radiculopathy : an comparative study. |
|
Scientific Title of Study
|
To compare the effect of scapula posture correction with neural flossing versus coventional exercises in cervical radiculopathy in dentist : an comparative 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 |
Shubhi Agarwal |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy college, Mahatma Gandhi
University of Medical Sciences and Technology, RIICO institutional
area, sitapura, tonk road, jaipur
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
6378122150 |
| Fax |
|
| Email |
shubhi1985@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Khandelwal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy college, Mahatma Gandhi
University of Medical Sciences and Technology, RIICO institutional
area, sitapura, tonk road, jaipur
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9928428453 |
| Fax |
|
| Email |
drkneurophysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Khandelwal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy college, Mahatma Gandhi
University of Medical Sciences and Technology, RIICO institutional
area, sitapura, tonk road, jaipur
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9928428453 |
| Fax |
|
| Email |
drkneurophysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy college, Mahatma Gandhi
University of Medical Sciences and Technology, RIICO institutional
area, sitapura, tonk road, jaipur, Rajasthan (India), 302022 |
|
|
Primary Sponsor
|
| Name |
Shubhi Agarwal |
| Address |
Krishna Oil and Dal Mill, Sundar Das Marg, Agrasen Colony, Dausa, Rajasthan (India),303303 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rakesh Khandelwal |
Mahatma Gandhi Hospital, Jaipur |
Neurology physiotherapy lab,Mahatma Gandhi Physiotherapy
College, Mahatma Gandhi University of Medical Sciences and
Technology, RIICO institutional area, sitapura, tonk road, jaipur
Jaipur
RAJASTHAN |
9928428453
drkneurophysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma GAndhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G542||Cervical root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
combination of both
Neural flossing and scapular muscles strengthening techniques, With postural exercises,
ergonomic advice, and a home regime plan. |
Subjects who will have cervical radiculopathy will receive a combination of both
Neural flossing and scapular muscles strengthening techniques, With postural exercises,
ergonomic advice, and a home regime plan.
Neural flossing Nerve flossing, also known as neural gliding or nerve gliding,
encompasses a gentle exercise methodology designed to enhance nerve mobility,
reduce pain, and improve overall functionality.
Scapular muscles strengthening
such as , Scapular wall push-ups, band pull aparts,
ITYWs, wall ball circles, forearm wall slides etc.
Ergonomical advice Upright posture , changing position frequently,sitting with a
supported posture etc.
During the pre and post hours of treatment by dentist, has to focus on StretchingTrapezius, Levator scapule, sternocleidomastoid with Isometrics of neck and active
ROM of neck for 4 weeks. |
| Comparator Agent |
Patient will receive conventional
exercises i.e neck range of motion , neck isometrics etc.
|
Subjects who will have cervical radiculopathy will receive conventional
exercises i.e neck range of motion , neck isometrics for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acute condition
Referral pain or any sort of radiating pain in the upper extremities or upper thorax
Pain, paresthesia or numbness in upper limb
Unilateral neck pain
Round shoulder due to poor posture |
|
| ExclusionCriteria |
| Details |
Dentists below 25 years and above the age of 60 years.
NPRS below 4
Previous shoulder or neck surgery
Pathological reflexes
Whiplash injuries
Hypertension or cardiovascular diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale (NPRS)
Neck Disability Index (NDI)
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index (NDI) |
2 Weeks |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Subjects who will meet the inclusion criteria will be informed about the study and written informed consent will be taken. 30 subjects will be randomly selected after this they will be randomly allocated into two groups. The procedure of treatment: Group 1 Subjects who will have cervical radiculopathy will receive a combination of both Neural flossing and scapular muscles strengthening techniques, With postural exercises, ergonomic advice, and a home regime plan. Neural flossing Nerve flossing, also known as neural gliding or nerve gliding, encompasses a gentle exercise methodology designed to enhance nerve mobility, reduce pain, and improve overall functionality. Scapular muscles strengthening such as , Scapular wall push-ups, band pull aparts, ITYWs, wall ball circles, forearm wall slides etc. Ergonomical advice Upright posture , changing position frequently,sitting with a supported posture etc. During the pre and post hours of treatment by dentist, has to focus on Stretching Trapezius, Levator scapule, sternocleidomastoid with Isometrics of neck and active ROM of neck Group 2 Subjects who will have cervical radiculopathy will receive conventional exercises i.e neck range of motion , neck isometrics etc |