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CTRI Number  CTRI/2022/12/048198 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On: 27/05/2023
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   Text neck syndrome correction with manipulation  
Scientific Title of Study   Effect of Cervicothoracic Cyriax manipulation on individuals with text neck syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Kumar 
Designation  MPT Student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana

Ambala
HARYANA
133207
India 
Phone  8962211394  
Fax    
Email  rk23011997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sunita Sharma 
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University , Mullana

Ambala
HARYANA
133207
India 
Phone  9467633734  
Fax    
Email  drsunita.sharma@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Sunita Sharma 
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University , Mullana

Ambala
HARYANA
133207
India 
Phone  9467633734  
Fax    
Email  drsunita.sharma@mmumullana.com  
 
Source of Monetary or Material Support  
Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of Physiotherapy, Maharishi Markandeshwar deemed to be University, Ambala, Haryana 
 
Primary Sponsor  
Name  Rahul Kumar  
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sunita Sharma  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rahul Kumar   Maharishi Markandeswar Hospital Department of Musculoskeletal Physiotherapy  Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA 		 8962211394

rk23011997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of the ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cyriax Manipulation  Supine position Traction with Occiput-chin grasp, suddenly rotate and apply thrust. Given 2 times a week for one week. 
Comparator Agent  Isometrics of neck  15 seconds hold 3 repetitions  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Both male and female
Age -18-30
Individuals using computers and phones for a long duration.(more than 4 hours/day)
 
 
ExclusionCriteria 
Details  Neuropathy
Universal hypermobility
Inflammatory joint
Muscular disease
Fracture of shoulder complex or neck
Patients who are unable to give consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
neck disability index (NDI)
 		 Total 3 times, pre intervention, after 1st session and after 2nd session
 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analog Scale (VAS)  Total 3 times, pre intervention, after 1st session and after 2nd session 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   24/12/2022 
Date of Study Completion (India) 18/03/2023 
Date of First Enrollment (Global)  24/12/2022 
Date of Study Completion (Global) 18/03/2023 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Ethical approval of this study will be taken from the student project committee and ethical committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Study will be done in accordance with Helsinki declaration revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participants, 2017. Recruitment and Intervention:
The objective of the study to see the effect of Cyriax manipulation on individuals with text neck syndrome, 45 participants aged 18 to 30 will be recruited from MMIPR based on inclusion/exclusion criteria. They will get Cyriax manipulation protocol, self stretching of trapezius, strengthening of rhomboids, chin tucks are given. As outcome measurements, VAS (Visual Analogue Scale) and NDI are used.
 
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