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CTRI Number  CTRI/2024/10/075759 [Registered on: 23/10/2024] 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   Comparison of Myofascial Release and Muscle Energy Techniques with Conventional Physiotherapy for Mechanical Neck Pain 
Scientific Title of Study   Comparative study on the effects of Myofascial release technique with conventional physiotherapy versus muscle energy technique with conventional physiotherapy on non – specific 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  Aakriti Jangid 
Designation  MPT Student 
Affiliation  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Ortho Lab, Department Of Physiotherapy, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University Of Medical Sciences And Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7976645586  
Fax    
Email  aakriti2031@mgumst.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhusudan Tiwari 
Designation  Dean and Principal 
Affiliation  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Dean And Principal Office, Department Of Physiotherapy, Mahatma Gandhi University Of Medical Sciences And Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290964159  
Fax    
Email  principal.physiotherapy@mgumst.org  
 
Details of Contact Person
Public Query  
Name  Dr Madhusudan Tiwari 
Designation  Dean and Principal 
Affiliation  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Dean and Principal Office, Department Of Physiotherapy, Mahatma Gandhi University Of Medical Sciences And Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290964159  
Fax    
Email  principal.physiotherapy@mgumst.org  
 
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), 302002 
 
Primary Sponsor  
Name  Aakriti Jangid 
Address  44, Kamla Niwas, Bara Mori Road, Near Kel Ki Bagichi, Opposite Gargi Public School, Brahampuri, Jaipur, Rajasthan, 302002 
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 Madhusudan Tiwari  Mahatma Gandhi Hospital,Jaipur  Room no.14, Physiotherapy OPD, Basement, Jaipur
Jaipur
RAJASTHAN 		 8290964159

principal.physiotherapy@mgumst.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Mahatma Gandhi 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: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Autogenic inhibition- Muscle energy technique in conjunction with conventional physiotherapy.   All participants will receive 1. Moist heat therapy for 20 minutes. 2.After moist heat therapy is finished, manual cervical traction applied for 90 seconds. 3.After applying manual traction, Muscle energy technique Autogenic inhibition will be administered. Repeated five times. 4.After MET, conventional exercises will be administrated. These are a. Active range of motion exercises. Repeated 5 times. b. Neck stretching exercises. Hold for about 20-30 seconds, then switch sides. c. Neck isometrics. Hold for 30 second and repeated it 5 times. 5. Treatment Duration Autogenic inhibition will be given for 6 session total 3 session per week and conventional therapy protocol on daily basis for 2 weeks.  
Intervention  Myofascial release technique in conjunction with conventional physiotherapy  All participants will receive 1.Moist heat therapy for 20 minutes. 2.After moist heat, manual cervical traction applied for 90 seconds. 3. After applying manual traction, Myofascial release technique applied. 4. After Myofascial release, conventional exercises will be administrated. These are a. Active range of motion exercises. Repeated 5 times. b. Neck stretching exercises. Hold for about 20 to 30 seconds, then switch sides. c. Neck isometrics. Hold for 30 seconds and repeated it 5 times. 5.Treatment Duration Myofascial release technique will be given for total 6 sessions 3 session per week and conventional therapy protocol on daily basis for 2 weeks. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Patients having complaints of neck pain and neck restriction for more than 2 weeks will be included.
2.Patients having a pain score of more than 3 and less than 7 in NPRS scale Evaluation.
3.Patients who were not receiving any other physiotherapy treatments were taken into consideration.
4.Patients willing to participate will be included.
5.Patients who can understand and obey instructions will be included.
 
 
ExclusionCriteria 
Details  1.Patients who have any history of trauma, fracture, or surgical procedure of the cervical or shoulder region will be excluded.
2.Patients suffering from any neurological conditions like Stroke, Parkinson and Multiple Sclerosis will be excluded.
3.Patients suffering from severe illnesses, such as cancer, inflammatory or rheumatic diseases, infections, and vascular disorders, will be excluded.
4.Patients receiving any other physiotherapy treatment will be excluded.
5.Patients with any metabolic disease of bone and joints will be excluded.
6.Patients with history of congenital torticollis will be excluded.
7.Patients with carcinoma will be excluded.
8.Patients with skin conditions will be excluded.
 
 
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 
Numeric Pain Rating Scale
Neck Disability Index  		 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale  1 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)   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  

40 subjects will be choosen for the study randomly.

 

 Group A 

This group will have 20 Participants and will be given intervention of Myofascial release technique in conjunction with conventional physiotherapy.


1.  All participants will receive 20 minutes of moist heat therapy while seated and reclining on a couch. The posterior aspect of the neck and the upper scapular region will be treated with moist heat therapy.


2.  After moist heat therapy is finished, manual cervical traction will be administered. The therapist applies manual traction by placing both hands at the base of the occiput and stretching up toward the top of the patient’s head. The thumbs were rested slightly on the lateral neck musculature. The other hand was over the upper thoracic spine. Gross stretch was performed by stretching upward at the base of the occiput and downward at the upper thoracic spine. The initial traction should just counterbalance the weight of the subject’s head. Stretch was hold for 90seconds until release and was stretched again by increasing traction.

 

3. After applying manual traction, Myofascial release technique will be administered as procedure mention below

   a. The patient will be then asked to sit well-supported in a chair.

   b. The therapist will set the head and spine in an anatomically neutral position.

   c. The therapist will make to gently explore the muscles around your neck. Feel for tender areas, tight bands, or trigger points.

  d. The therapist will make gentle contact with skin a downward or vertical pressure was applied until resistance was felt and perform gliding or sustained pressure techniques along the muscles of the neck moving in the direction of the muscle fibers.

  e. After applying the resistance a horizontal pressure was added until resistance barrier was felt. Both pressures were sustained   for about 30-60 seconds, allowing the muscles to release tension.


4.   After Myofascial release technique , conventional exercises will be administrated. These are

a. Active range of motion exercises sitting patient actively performed shoulder rolls, forward bending, neck extension, and rotations of the neck on both sides. Repeated 5 times.


b.  Neck stretching exercises like Levator Scapula Stretch, Upper Trapezius Stretch, Chin Tucks, Scalene Stretch are performed by therapist. Hold for about 20-30 seconds, then switch sides.


c.  Neck isometrics to strengthen the neck, the patient pushed isometrically against the hand  while seated. Hold for 30 sec. and repeated it 5 times.


    Group B 

    This group will have 20 Participants and will be given the intervention of the Autogenic inhibition- Muscle energy technique in conjunction with conventional physiotherapy.

1.  All participants will receive 20 minutes of moist heat therapy while seated and reclining on a couch. The posterior aspect of the neck and the upper scapular region will be treated with moist heat therapy.


2.  After moist heat therapy is finished, manual cervical traction will be administered. The therapist applies manual traction by placing both hands at the base of the occiput and stretching up toward the top of the patient’s head. The thumbs were rested slightly on the lateral neck musculature. The other hand was over the upper thoracic spine. Gross stretch was performed by stretching upward at the base of the occiput and downward at the upper thoracic spine. The initial traction should just counterbalance the weight of the subject’s head. Stretch was hold for 90seconds until release and was stretched again by increasing traction.


3.   After applying manual traction, Muscle energy technique (Autogenic inhibition) will be administered.


4.  The patient will be then asked to sit well-supported in a chair. The therapist will set the head and spine in an anatomically neutral position. The therapist included stretching of the affected muscle and performing isometric contraction with 50 percentage of the total patient’s effort in the same muscle that was being stretched and position hold for 10 seconds, with 5 seconds of rest after every repetition. This procedure was repeated five times.


5.  After MET, conventional exercises will be administrated. These are

a. Active range of motion exercises sitting patient actively performed shoulder rolls, forward bending, neck extension, and rotations of the neck on both sides. Repeated 5 times.

b. Neck stretching exercises like Levator Scapula Stretch, Upper Trapezius Stretch, Chin Tucks, Scalene Stretch are performed by therapist. Hold for about 20-30 seconds, then switch sides.

c.  Neck isometrics to strengthen the neck, the patient pushed isometrically against the hand while seated. Hold for 30 second. and repeated it 5 times.

 

Treatment Duration Myofascial release technique will be given for total 6 sessions (3 session per week) and Autogenic inhibition (MET) will be given for 6 session total (3 session per week) and conventional therapy protocol on daily basis for 2 weeks.

 
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