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CTRI Number  CTRI/2024/07/069754 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 30/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparative Effect of Combined Mckenzie Therapy and Muscle Energy Technique Versus Mckenzie Therapy on Mechanical Neck Pain 
Scientific Title of Study   Comparative Effect of Combined Mckenzie Therapy and Muscle Energy Technique Versus Mckenzie Therapy on Pain, Range of Motion, and Function in Individuals with Postural and Dysfunctional Mechanical Neck Pain- A Quasi-Experimental 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  SILPA KC  
Designation  Master of physiotherapy student  
Affiliation  Institute of physiotherapy/ Srinivas University  
Address  Department of physiotherapy,Institute of physiotherapy, Srinivas University, Pandeshwar, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8078238907  
Fax    
Email  silpakc64@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Kamalakannan  
Designation  Associate professor  
Affiliation  Institute of physiotherapy/ Srinivas University  
Address  Department of physiotherapy,Institute of physiotherapy, Srinivas University, Pandeshwar, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9500931424  
Fax    
Email  kamalakannan.pt@gmail.com  
 
Details of Contact Person
Public Query  
Name  SILPA KC  
Designation  Master of physiotherapy student 
Affiliation  Institute of physiotherapy/ Srinivas University  
Address  Department of physiotherapy,Institute of physiotherapy, Srinivas University, Pandeshwar, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8078238907  
Fax    
Email  silpakc64@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  SILPA KC 
Address  Department of physiotherapy,Institute of physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakshina Kannada 
Type of Sponsor  Other [Nil] 
 
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 SILPA KC   Institute of physiotherapy, Srinivas university   Department of physiotherapy, Institute of physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA 		 8078238907

silpakc64@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRINIVAS UNIVERSITY ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mckenzie exercise   Neck extension in supine,Retraction,Neck flexion in sitting, Neck extension, Lateral bending and Head turning for 10 seconds with 10 reputation each. Duration: 5 sessions per week for 6 weeks. 
Intervention  Mckenzie exercise and Muscle energy technique.  1. Mckenzie exercise: Neck extension in supine,Retraction,Neck flexion in sitting, Neck extension, Lateral bending and Head turning for 10 seconds with 10 reputation each. 2. Muscle energy technique: for upper trapezius muscle, levator scapulae, and sternocleidomastoid muscle with a 10 seconds of contraction. Duration: 5 sessions per week for 6 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. NSNP more than 7 days.
2. Patients aged between 20 - 55.
3. Both males and females.
4. Postural and dysfunctional syndrome.
5. NPRS pain intensity. 
 
ExclusionCriteria 
Details  1. Currently diagnosed with cervical disc prolapse.
2. Tumors of cervical spine.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Neck disability index  1 day, 6 week 
 
Secondary Outcome  
Outcome  TimePoints 
NPRS
Bubble inclinometer
Craniovertebtal angle
Muscle length testing
Global rating of change scale 		 1 day,6 week 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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/ Phase 3 
Date of First Enrollment (India)   15/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The study aims to compare the combined effects of McKenzie therapy and Muscle Energy Technique (MET) versus McKenzie therapy alone on pain, cervical range of motion (ROM), and function in individuals with postural and dysfunctional mechanical neck pain. Participants will be recruited from Srinivas University and Srinivas Medical College Hospital in Mangalore, screened for eligibility, and divided into two groups: Group A (McKenzie exercises + MET) and Group B (McKenzie exercises). Baseline assessments will include NPRS, bubble inclinometer, craniovertebral angle, muscle length testing, and NDI. Both groups will undergo their respective interventions, including moist heat, five sessions per week for six weeks. Post-treatment assessments will be conducted after six weeks. McKenzie exercises involve head retraction, neck extension, lateral bending, head-turning, and neck flexion, each held for 10 seconds and repeated 10 times. MET for the upper trapezius , sternocleidomastoid and levator scapulae involves specific isometric contractions and passive stretches, each held for 10 seconds.




 
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