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CTRI Number  CTRI/2024/10/075911 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 19/10/2024
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   To Compare Effect of Two Techniques in Individuals with Neck Pain 
Scientific Title of Study   Comparative Effectiveness of Instrument Assisted Soft Tissue mobilization and Muscle Energy Technique on Posture and Pain in Individuals with Chronic 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  Meera Gupta 
Designation  Post Graduate Student (Master of Physiotherapy) 
Affiliation  Indian Spinal Injury Center - Institute of Rehabilitation sciences 
Address  Room no 6, 2nd floor, Indian Spinal Center - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9354939714  
Fax    
Email  meeragupta0523@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitra Kataria 
Designation  Professor and Principal 
Affiliation  Indian Spinal Injury Center - Institute of Rehabilitation sciences 
Address  Secretariate, 2nd floor, Indian Spinal Center - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi

South West
DELHI
110011
India 
Phone  9810310670  
Fax    
Email  rehab@isiconline.org  
 
Details of Contact Person
Public Query
 
Name  Meera Gupta 
Designation  Post Graduate Student (Master of Physiotherapy) 
Affiliation  Indian Spinal Injury Center - Institute of Rehabilitation sciences 
Address  Room no 6, 2nd floor, Indian Spinal Center - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9354939714  
Fax    
Email  meeragupta0523@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre - Institute of rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi, South West Delhi, 110070, India 
 
Primary Sponsor  
Name  None 
Address  N/A 
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 
Meera Gupta  Indian spinal Injuries Center Institute of Rehabilitation Sciences  Rehabilitation Department, Ground Floor, Sector C, Vasant Kunj, New Delhi-110070
South West
DELHI 
9354939714

meeragupta0523@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Indian Spinal Injuries Center  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 
Intervention  Instrument Assisted Soft Tissue Mobilization  Instrument Assisted Soft Tissue Mobilization will be given manually in combination with conventional therapy for 2 sessions over the course of 2 weeks 
Comparator Agent  Muscle Energy Technique  Muscle Energy Technique will be given manually in combination with conventional therapy for 2 sessions over the course of 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Age 18-40 years, Chronic mechanical neck pain (more than 3 months), Craniovertebral Angle (CVA) less than 48 degrees, willingness to participate 
 
ExclusionCriteria 
Details  patient diagnosed with any recent surgery, trauma or unhealed fracture of cervical spine, cervical spine surgery. patient diagnosed with neck pain secondary to disorders (like neoplasm, cardiovascular disease, spasmodic torticolis, radiculopathy with neurological deficits), systemic diseases (like infection or inflammatory arthritis of cervical spine). any open wound around neck, skin conditions (like petechie, ecchymosis), allergy to metal emolients, anti-coagulant therapy, patient intolerance and hypersensitivity to pain. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale  Day 0 (baseline, Pre-test), at 2 week (Post-test) 
 
Secondary Outcome  
Outcome  TimePoints 
Pain Pressure Threshold  Day 0 (baseline, Pre-test), at 2 week (Post-test) 
Craniovertebral Angle  Day 0 (baseline, Pre-test), at 2 week (Post-test) 
Cervical Range of Motion  Day 0 (baseline, Pre-test), at 2 week (Post-test) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   31/10/2024 
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="7"
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  

Pain in the anatomic region of neck is known as mechanical neck pain which is primarily caused by overuse of a normal anatomical structure, secondary to injury and deformity of anatomical structure. 

Existing literature shows effectiveness of both the techniques on chronic mechanical neck pain as instrument assisted soft tissue mobilization with the help of specialized instrument apply strokes which releases muscle tension and improve flexibility. Whereas muscle energy technique works on the principle of post-isometric relaxation by which relaxes and further lengthen muscles. Both techniques are found effective in treating chronic mechanical neck pain separately. However, to best of our knowledge no study has checked comparative effectiveness of the two effective techniques.

Patients will be screened based on inclusion and exclusion criteria and then they will be enrolled into 2 groups with the help of random allocation software. (Group 1) will receive instrument assisted soft tissue mobilization along with conventional physiotherapy. (Group 2) will receive muscle energy technique along with conventional physiotherapy for 4 sessions in course of 2 weeks.

The outcome measurement will be done by numeric pain rating scale for pain, algometer for Pain Pressure threshold, Craniovertebral angle for forward head posture and Goniometer for cervical range of motion. Variations in the pre and post outcome measure will help us to find out which technique is more effective.

 
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