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CTRI Number  CTRI/2024/02/062645 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Added benefits of core muscle training in treatment of long term neck pain in teachers. 
Scientific Title of Study   Efficacy of back core stability training along with deep cervical flexor training among teachers with chronic mechanical neck pain. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashi Talukdar  
Designation  PG Student 
Affiliation  Amity Institute of Health and Allied Sciences, Amity University  
Address  Lower ground floor, F1 block, Departure of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University,Sector 125, Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  7042446001  
Fax    
Email  rashi23tallu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pankaj Kumar Malik 
Designation  Assistant professor  
Affiliation  Amity Institute of Health and Allied Sciences, Amity University  
Address  Room no F1 107A, F1 block, Departure of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9899274238  
Fax    
Email  pkmalik@amity.edu  
 
Details of Contact Person
Public Query  
Name  Pankaj Kumar Malik 
Designation  Assistant professor  
Affiliation  Amity Institute of Health and Allied Sciences, Amity University  
Address  Room no F1 107A, F1 block, Departure of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9899274238  
Fax    
Email  pkmalik@amity.edu  
 
Source of Monetary or Material Support  
Shanti Gyan Niketan Junior School, Goyla khurd, near Sector 19 Dwarka, New Delhi, Delhi 110071 
 
Primary Sponsor  
Name  Rashi  
Address  F1 block, Department of Physiotherapy, Amity University, sector 125 Noida, Uttar Pradesh  
Type of Sponsor  Other [Self] 
 
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 
Rashi  Shanti gyan niketan junior school  Goyla khurd near, Sector 19, Dwarka, New Delhi, Delhi 110071
South West
DELHI 		 7042446001

rashi23tallu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional NTCC Committee, Amity Institute of Health and Allied Sciences, Amity University Uttar Pradesh   Approved 
Local NOC Shanti Gyan Niketan School  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core Stability Training   Group A will perform Core stability exercise along with deep cervical flexor exercise. Core stability exercises will be started by teaching the patients the basic exercises with use of aneroid sphygmomanometer. 1. The patient will be in supine position with knee flexed to 90-degree flexion. 2. The pressure cuff will be placed under the lumbar spine, patient will be asked to do abdominal hollowing maneuver (tummy tuck in-out) After teaching abdominal hollowing, exercise will be progressed to further exercises 1. Bridging exercise 2. Bird dog exercise 3. Abdominal crunch against wall. Exercise will be done of 10 repetition, with 10 second hold and 5 sec rest in between. Exercise will be performed 3 times a week for alternate days, for 4 weeks. 
Comparator Agent  Deep Cervical Flexor Training  Group B will perform Deep Cervical Flexor Exercise. Exercises will be performed with use of aneroid sphygmomanometer, placed in the sub-occipital region to monitor the flattening of the cervical lordosis. The exercises will start by teaching the patient to contract deep cervical flexors. The patient will be in supine hook position without pillow to ensure the neutral position of the neck. Gradual training will be given to increase the pressure value between 20mmHg and 30mmHg While providing motor control with aneroid sphygmomanometer, the patient is asked to slowly do chin tucks. Command will be given as; slowly move your chin closer to your chest. Once the stabilization of neck will be achieved, training will be gradually progressed in sitting and in standing. Exercise will be done of 10 repetition, with 10 second hold and 5 sec rest in between. Exercise will be performed 3 times a week for alternate days, for 4 weeks. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patient age from 25 years to 45 years, both males and females, teachers with mechanical neck pain and forward head posture, neck pain for more than 3 months, visual analog scale upto 5, teaching experience of more than 5 years,consent to participate. 
 
ExclusionCriteria 
Details  Any ongoing treatments for neck pain or on painkillers, positive neurological sign, any history of recent injury to neck, spinal surgery, spinal instability, history of any musculoskeletal, neurological, symptomatic disease which can affect the performance in the current study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain, Neck disability, Active cervical Range of motion, Cranial-Rotation Angle and Cranio-Vertebral Angle  Baseline, week 2 and after week 4 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life   Baseline, week 2 and after week 4 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 2 
Date of First Enrollment (India)   19/02/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   To investigate the additional effects of core stability training in teachers with chronic mechanical neck pain, two groups will perform certain exercise training for cervical - group A will do deep cervical flexor training, and for group B will do core stability training in addition to deep cervical flexor training. Training will be done with the use of aneroid Sphygmomanometer to ensure quality and precision in exercise performance. Outcome measures will be taken which are NPRS, active cervical ROM, Neck disability index scale measure, neck posture- CVA and CRA measurements. 
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