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CTRI Number  CTRI/2020/03/024367 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 26/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two techniques in chronic neck pain and their effect on pain, muscle strength and disability 
Scientific Title of Study   Effect of positional release technique and myofascial release technique on pain,muscle activity, strength and disability in patients with Chronic Neck Pain 
Trial Acronym  MFR; PRT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Md Shahid Raza 
Designation  Assistant professor 
Affiliation  Jamia Millia Islamia 
Address  Room no. 106,Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia New Delhi 110025 India

South
DELHI
110025
India 
Phone  9212156165  
Fax    
Email  mraza1@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Md Shahid Raza 
Designation  Assistant professor 
Affiliation  Jamia Millia Islamia 
Address  Room no. 106,Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia New Delhi 110025 India

South
DELHI
110025
India 
Phone  9212156165  
Fax    
Email  mraza1@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  Saniya khatoon 
Designation  PG student 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia New Delhi 110025 India

South
DELHI
110025
India 
Phone  8750864852  
Fax    
Email  drsaniya7860@gmail.com  
 
Source of Monetary or Material Support  
Jamia millia university 
 
Primary Sponsor  
Name  jamia millia islamia 
Address  jamia millia islamia, okhla, new delhi 110025 india  
Type of Sponsor  Other [[Central university]] 
 
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 
Shahid Raza  CPRS, jamia millia islamia  CPRS jamia millia islamia , New Delhi
South
DELHI 		 9212156165

mraza1@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Jamia Millia Islamia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Myofascial release technique Positional release technique  Group 1: Myofascial release technique,hot pack and diadynamic current Group 2: Positional release technique,hot pack and diadynamic current 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Chronic neck pain (more than 3 months of duration);age group 20-55 yrs;Latent trigger points in upper trapezius muscle present on both the sides;Local pain score of 3-7/10 NPRS; elicited by 2.5kg/cm2 pressure with an algometer; BMI normal. 
 
ExclusionCriteria 
Details  History of myofascial pain therapy in cervical region within past month before the study;Trigger point injection past 6 months; Nerve root involvement /radiculopathy; History of cervical degenerative joint; Neck pain with significant trauma.
Malignancy, infection.
Spinal cord compromise.
History of neck surgery. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mcgill pain questionnaire, Electromyography, Lafayette hand held dynamometer, Neck Disability Index  pre and post intervention- 1st at starting and 2nd at the end of intervention at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Neck Disability Index  pre and post intervention- 1st at starting and 2nd at the end of intervention at 4 weeks 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   30/03/2020 
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    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is aimed at to find out that which technique is better in improving chronic neck pain, disability, muscle strength and muscle activity of a patient suffering from chronic neck pain. Pre-test will be done by: performing EMG on upper traps at rest and on activity, Mcgill pain questionniare, NDI, strength will be assessed via lafayette hand held dynamometer. The subjects will be randomly allocated into two groups. Positional release technique group will receive : Hot pack for 15 min, Diadynamic currents for 12 minutes and positional release technique three times for 90 seconds each and Myofascial release  group will recieve hot pack for 15 min,MFR 90-120 seconds, 3-5 times, Diadynamic currents for 12 minutes. After four weeks of intervention, the two groups will be assessed via: EMG will be performed on upper traps at rest and at on activity, Mcgill pain questionnaire, NDI and strength will be assessed via lafayette hand held dynamometer.

 
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