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CTRI Number  CTRI/2024/04/065607 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Immediate Effect of Integrated Neuromuscular Inhibition Technique Versus Integrated Neuromuscular Inhibition Technique in Patient With Subacute Trapezitis a Comparative study  
Scientific Title of Study   IMMEDIATE EFFECT OF INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE VERSUS INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE IN PATIENT WITH SUBACUTE TRAPEZITIS- 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  Aman Shankar Yadav  
Designation  Intern 
Affiliation  Dr Ulhas patil college of physiotherapy Jalgaon 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 India

Jalgaon
MAHARASHTRA
42530
India 
Phone  7506933499  
Fax    
Email  yamuchand1411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Shinde 
Designation  Assistant professor 
Affiliation  Dr Ulhas patil college of physiotherapy Jalgaon 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 India

Jalgaon
MAHARASHTRA
42530
India 
Phone  9021047555  
Fax    
Email  mukeshshinde31@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh Shinde 
Designation  Assistant professor 
Affiliation  Dr Ulhas patil college of physiotherapy Jalgaon 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 India

Jalgaon
MAHARASHTRA
42530
India 
Phone  9021047555  
Fax    
Email  mukeshshinde31@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ulhas Patil college of physiotherapy , Jalgaon MAHARASHTRA 42530 INDIA 
 
Primary Sponsor  
Name  DRULHAS PATIL COLLEGE OF PHYSIOTHERAPY 
Address  NH 06 Gat No 57 Khirdi ShivarTal And DistJalgaon Jalgaon MAHARASHTRA 42530 India 
Type of Sponsor  Private medical college 
 
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 Mukesh Shinde  DR ULHAS PATIL COLLEGE   NH 06 Gat No 57 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 India
Jalgaon
MAHARASHTRA 
9021047555

mukeshshinde31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee of Dr Ulhas Patil college of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy active and inactive individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IMMEDIATE EFFECT OF INTEGRATED NEUROMUSCULAR TECHNIQUE VERSUS INTEGRATED NEUROMUSCULAR TECHNIQUE IN PATIENT WITH SUBACUTE TRAPEZITIS  6 MONTHS STUDY AND IT IS IMMEDIATE EFFECT  
Comparator Agent  not applicable   not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  a)Individual with trigger points in trapezius muscle
b)Individual having pain for about 3weeks up to 3 months
c)Having no specific pathology involved
d)Subjects between the age group of 18-30 years
e)Both Gender
f)Pain intensity on NPRS between 2 to 6
Individual who are willing to take part in study.
 
 
ExclusionCriteria 
Details  a)Individual with any neurological problems related to cervical spine.
b)patients with trauma and surgery around neck and shoulder in past one year.
c) cervical myelopathy, congenital anomalies like torticollis etc.
d)motor weakness of upper limb and fibromyalgia.
e)Hypersensitivity of skin
 
 
 
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 
NUMERICAL PAIN RATING SCALE
Cervical contralateral side flexion ROM which was taken by universal goniometer.
NDI score.

 
6 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   21/04/2024 
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="2"
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   Ethical clearance will be obtained from institutional ethical committee & principal of Dr. Ulhas Patil college of physiotherapy. A Written informed consent form will be obtained from subject who are willing to participate.
 
 subject will be screened according to inclusion and exclusion criteria . The aim and objective will be explained to the patient. selected participants demographic details and outcome measure will be recorded . 

To check effectiveness of INIT AND INIT WITH SURGED FARADIC THREE OUTCOMES ARE USE PRE TREATMENT AND POST TREATMENT
1. NPRS
2. NDI
3. CERVICAL CONTRALATERAL RANGE OF MOTION 

INIT CONSITS OF THREE METHODS 
1. ISCHEMIC COMPRESSION
2. SCS
3. MET 

ISCHEMIC COMPRESSION : 1)The subjects was placed in supine to reduce tension in the upper trapezius muscle.
2)Their arm was positioned in slight shoulder abduction with the elbow bent and their hand resting on their stomach.
3)Using a pincer grasp, the practitioner moved throughout the fibers of the upper trapezius and made note of any active Trigger point.
4)Once the Trigger point was identified treatment began.
5)The first technique applied was ischemic compression.
6)The therapist again utilized a pincer grasp, placing the thumb and index finger over the active Trigger point.
7) Slow, increasing levels of pressure was applied until the tissue resistance barrier was identified
8)Pressure was maintained until a release of the tissue barrier was felt.
9) At that time, pressure was again applied until a new barrier was felt.
10) This process was repeated until tension/tenderness was unable to be identified or 90 s had elapsed, whichever came first.
11)All identified Trigger point were treated.
STRAIN COUNTER STRAIN :Subject in supine position and pressure was applied at painful spot then arm was moved in to abduction and external rotation to achieve the position of comfort or ease in such a way that pain is relived or reduced from the palpated point.

This position was maintained for about 90 seconds. After which isometric contraction of the muscle was elicited in the form of MET.

MET :

Subjects randomized to the MET group received treatment as per post-isometric relaxation approach.
The subjects were placed supine and the practitioner stabilized the shoulder on the affected side with one hand, while the ear/mastoid area of the affected side was held by the opposite hand.
The head and neck were then side bent towards the contralateral side, flexed, and rotated ipsilaterally, placing the subject just short of their upper trapezius restriction barrier.
 The subjects then shrugged the involved/stabilized shoulder towards the ear at a submaximal, pain-free, effort (20% of their available strength). The isometric effort was held for 7–10 s while a normal breathing rhythm was maintained.
 During the relaxation phase, the head and neck were eased into increasing degrees of side bending, flexion and rotation to advance the stretch placed on the muscle. Each stretch was held for 30 s, and this was repeated for three to five repetitions.
SURGED FARADIC CURRENT : 
Patient position- Patient in supine position.
Instruction- The patient should be comfortably seated/ supine lying with arm support. Patient is asked to keep the part to be treated still and relaxed and to report any increase pain or other sensation immediately.
Preparation of treatment part- The area should be clean.
 Frequency: 50 HZ
Mode: SURGED FARADIC
PULSE DURATION: 0.1 – 1 microsecond
Duration: 10 Minutes.
AFTER  TREATMENT AGAIN OUTCOMES WERE MEASURED
RESULTS: THERE WAS SIGNICANT INCREASE IN RANGE OF MOTION 
DECREASE IN PAIN 
AND FUNCTINAL DISABILITY  WERE IMPROVED
 
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