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CTRI Number  CTRI/2024/11/076719 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
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   Comparing Isometric Exercises versus Dynamic Exercises with Myofascial Release in Cervical Spondylosis 
Scientific Title of Study   Effectiveness of Isometric Neck Exercises along with Myofascial Release Technique versus Dynamic Neck Exercises along with Myofascial Release Technique on the Pain, Function and Quality of Life in Case of Cervical Spondylosis: A 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  Parnika Gulabani  
Designation  MPT Student  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology 
Address  Room No 14,Physiotherapy OPD, Basement, Mahatma Gandhi Hospital , Mahatma Gandhi University of Medical Sciences and Technology, RICCO instituitional area, Sitapura, Tonk road, Jaipur Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  6350091030  
Fax    
Email  parnika2007@mgumst.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemendra Kumar Sharma 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Room No 14,Physiotherapy OPD, Basement, Mahatma Gandhi Hospital , Mahatma Gandhi University of Medical Sciences and Technology, RICCO instituitional area, Sitapura, Tonk road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9460888177  
Fax    
Email  hemendra.physio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemendra Kumar Sharma 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology 
Address  Room No 14, Physiotherapy OPD,Basement , Mahatma Gandhi Hospital , Mahatma Gandhi University of Medical Sciences and Technology, RICCO instituitional area, Sitapura, Tonk road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9460888177  
Fax    
Email  hemendra.physio@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy College ,Mahatma Gandhi Univwesity of Medical Sciences and Technology , RIICO Institutional area,Sitapura, tonk road,jaipur,rajasthan (India),302022 
 
Primary Sponsor  
Name  Parnika Gulabani 
Address  G1 Plot No C16 Milan Apartment, Kusum Vihar, Jaipur,PO:Jagatpura,Dist:Jaipur,Rajasthan-302017 
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 
Dr Hemendra Kumar Sharma  Mahatma Gandhi Hospital ,Jaipur  Room No. 14 Physiotherapy OPD Basement
Jaipur
RAJASTHAN 
9460888177

hemendra.physio@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  The effectiveness of Isometric neck exercises along with Myofascial Release Technique versus Dynamic neck Exercises along with Myofascial Release Technique  40 participants will randomly be divided into two groups. In Group A: all 20 patients will be treated by Isometric neck exercise along with myofascial release. Group B: all 20 patients will be treated with dynamic neck exercise along with myofascial release. All participants will be assessed for cervical pain, function, and quality of life. The Numeric Pain Rating Scale (NPRS) will be used to measure the intensity of pain, functional performance will be assessed using the Neck Disability Index (NDI) and quality of life will be assessed by SF-36. All variables will be measured at baseline, at the end of the second week and Fourth week of the study. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with chronic stage neck pain (above 7 weeks)
Patients with Neck Disability Index (NDI) score above 15/50
Diagnosed with Cervical spondylosis and referred by an orthopedician of the Orthopedic department of MGH
Chronic stages of tissue healing
Tension headache
 
 
ExclusionCriteria 
Details  Patients with less than 14/50 on the Neck Disability Index (NDI) score
Acute pain & inflammation
Acute inflammatory period in rheumatoid arthritis
Torticollis
Unstable/acute osteoarthritis
Recent fractures
Vertigo
Vertebrobasilar insufficiency
Chronic heart disease, Myocardial infarction
Pregnancy
 
 
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 
Pain by using the NPRS scale
NDI – score for Function
Quality of life by using SF-36 score Instrument

 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pain by using the NPRS scale NDI – score for Function
Quality of life by using SF-36 score Instrument

 
1st week and 2nd week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   23/11/2024 
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 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  
40 participants will randomly be divided into two groups. In Group A: all 20 patients will be treated by Isometric neck exercise along with myofascial release. Group B: all 20 patients will be treated with dynamic neck exercise along with myofascial release. All participants will be assessed for cervical pain, function, and quality of life. The Numeric Pain Rating Scale (NPRS) will be used to measure the intensity of pain, functional performance will be assessed using the Neck Disability Index (NDI) and quality of life will be assessed by SF-36. All variables will be measured at baseline, at the end of the second week and Fourth week of the study.

Group A: Isometric neck exercise along with MFR 

Isometric Neck Flexion:
Sit or stand with a straight spine and place your hand on your forehead.  Push your forehead gently against your hand without allowing any actual movement. Hold the contraction for 5-10 seconds. Relax and repeat for 10 repetitions.

Isometric Neck Extension:
Place your hands on the back of your head. Push your head backward against your hands without allowing any actual movement. Hold the contraction for 5-10 seconds. Relax and repeat for 10 repetitions.

Isometric Lateral Neck Flexion 
Place your right hand on the right side of your head.  Push your head to the right against your hand without allowing any actual movement. Hold the contraction for 5-10 seconds. Relax and repeat on the left side. Perform 10 repetitions on each side.

Isometric Neck Rotation 
Place your right hand on the right side of your face.  Push your head to the right against your hand without allowing any actual movement. Hold the contraction for 5-10 seconds. Relax and repeat on the left side. Perform 10 repetitions on each side.
10 repetitions were given per session with 30 secs of rest will be given in between the session. Total 6 sessions in a week for 4 weeks

MYOFASCIAL RELEASE

Patient position: Sitting 

Procedure: The therapist stand behind the patient, then with hands crossed with one hand placing on the shoulder and the other below the ear on the head of the involved side. The hands are placed along the direction of the fibres. Local myofascial stretch for 20 seconds is given slowly and repeated 3-4 times. 
4 repetitions were given per session with 30 secs of rest will be given in between the session. Total 6 sessions in a week for the period of 4 weeks.
Subjects in both the groups will be receiving the above protocol along with physical modality such as TENS.
Transcutaneous electrical nerve stimulation (TENS) will be given on painful areas in both groups A and B for 6 days a week for an initial 2 weeks according to the protocol mention below:
Frequency:5Hz Intensity: high Pulse duration: 300 Micro sec. Duration: 20 minutes, Electrode placement: Area of greatest intensity of pain.

Group B: Dynamic neck exercise along with MFR 
 
Neck Flexion and Extension:

Sit or stand with a straight spine.  Slowly lower your chin towards your chest, feeling a stretch in the back of your neck.   Return to the neutral position and then gently tilt your head backward, looking up towards the ceiling Repeat for 10 repetitions.

Neck Lateral Flexion:

Slowly tilt your head to the right, bringing your ear towards your shoulder. Return to the neutral position and then tilt your head to the left.  Repeat for 10 repetitions on each side.

Neck Rotation:

Turn your head to the right, looking over your shoulder. Return to the neutral position and then turn your head to the left.  Repeat for 10 repetitions on each side.

Shoulder Blade Squeezes:

Sit or stand with good posture. Squeeze your shoulder blades together, bringing them towards your spine. Hold for a few seconds and then release. Repeat for 10 repetitions.
10 repetitions were given per session with 30 secs of rest will be given in between the session. Total 6 sessions in a week for 4 weeks
 


MYOFASCIAL RELEASE

Patient position: Sitting 
Procedure: The therapist stands behind the patient, with hands crossed with one hand placed on the shoulder and the other below the ear on the head of the involved side. The hands are placed along the direction of the fibers. Local myofascial stretch for 20 seconds is given slowly and repeated 3-4 times. 
4 repetitions were given per session with 30 secs of rest will be given in between the session. Total 6 sessions in a week for 4 weeks. Subjects in both groups will be receiving the above protocol along with physical modalities such as TENS.
Transcutaneous electrical nerve stimulation (TENS) will be given on painful areas in both groups A and B for 6 days a week for an initial 2 weeks according to the protocol mentioned below:
Frequency:5Hz Intensity: high Pulse duration: 300 Micro sec. Duration: 20 minutes, Electrode placement: Area of greatest intensity of pain.

 
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