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CTRI Number  CTRI/2025/02/080603 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect Of Soft Tissue Mobilisation In Non Specific Chronic Neck Pain 
Scientific Title of Study   Efficacy Of Instrument Assisted Soft Mobilisation Over Myofascial Release Technique In Individuals With Non Specific Chronic 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  Mohanasundaram K 
Designation  student  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur,chennai -600116.

Chennai
TAMIL NADU
600116
India 
Phone  7358239554  
Fax    
Email  mohankms119@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Angeline R 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur,chennai -600116.

Chennai
TAMIL NADU
600116
India 
Phone  9943529400  
Fax    
Email  angelinejobin.75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Angeline R 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur,chennai -600116.

Chennai
TAMIL NADU
600116
India 
Phone  9943529400  
Fax    
Email  angelinejobin.75@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute Of Higher Education And Research , faculty of physiotherapy, no.1 sri ramachandra nagar,porur,chennai -600116.  
 
Primary Sponsor  
Name  Mohanasundaram K 
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur,chennai -600116.  
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 Mohanasundaram K  Sri Ramachandra Institute of Higher Education and Research  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur,chennai -600116.
Chennai
TAMIL NADU 		 7358239554

mohankms119@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR Registration No:EC/NEW/INST/2023/TN/0321  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Instrument Assisted Soft Tissue Mobilisation   Subjects in this group receive the Instrument Assisted Soft Tissue Mobilisation technique using an M2T blade twice a week for four weeks. The subject assumed a comfortable sitting position leaning on a treatment table with the arm crossed to rest the head. After cleaning the skin of the subject and the blade with alcohol swabs, a lubricant (Vaseline) was applied, and a sweeping technique was used to apply a deep yet comfortable soft tissue mobilization on the upper trapezius from origin to insertion for approximately 3  min. The technique was adjusted if needed to allow the subject to take a break if a sense of burning was felt or if the treatment was uncomfortable. The skin was then cleaned and wiped with tissues. Subjects were instructed that slight hyperemia on the skin is a normal feeling and should subside before the next session. Treatment was applied bilaterally to both the shoulder.  
Comparator Agent  manual myofascial release  Subjects in this group will receive Myofascial release twice a week for four weeks. While the subject was in a supine position with his/her head supported, the subject’s head was rotated away from the side to be treated, and the therapist crossed her hands as shown in to take up the slack of the upper trapezius muscle until the tissue barrier was felt. A stretching force was maintained for 30seconds at the tissue barrier before moving to a new barrier. The technique was repeated until the end range is reached. Lateral bending of the head was avoided and if more stretching was needed, the therapist depressed the shoulder more at the same time the head was rotated. The subjects were continuously assessed for any discomfort or pain beyond comfortable stretching pain. Both sides of the neck were treated. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosis
Nonspecific chronic neck pain lasting at least 12 weeks without a specific pathological cause.

Age Range
18–60 years.

Pain Intensity
Moderate pain (VAS score: 3–7 out of 10).

Functional Impairment
Functional limitations in daily activities due to neck pain, assessed by the Neck Disability Index (NDI).

Trigger Points
Presence of active or latent myofascial trigger points (MTrPs) identified by clinical palpation.
 
 
ExclusionCriteria 
Details  Specific Neck Pain
Neck pain caused by specific conditions (e.g., cervical radiculopathy, myelopathy, fractures, systemic inflammatory conditions).

Neurological Disorders
Presence of nerve root compression signs (e.g., numbness, tingling, or muscle weakness).

Recent Surgery/Trauma
History of neck or upper limb surgery or acute trauma within the last 6 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain intensity(VAS)
 		 Baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
pain pressure threshold
 		 Baseline & 4 weeks 
endurance
 		 Baseline & 4 weeks 
cervical range of motion  Baseline & 4 weeks 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   21/02/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mohankms119@gmail.com].

  6. For how long will this data be available start date provided 01-02-2025 and end date provided 01-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The current study will be performed after the approval of the Ethical Committee. Informed consent will be obtained from each subject included in this study. All patients will be subjected to the following: History taking and full clinical examination (general and local neck examination).Pain assessment will be conducted using the VAS (0–10 scale).Subjects will be assessed for the presence or absence of MTrPs. This will include the presence of a palpable taut band in a muscle, the presence of a hypersensitive point in a taut band, a twitch in a muscle caused by palpation, referred pain produced as a result of compression on a tender point, and/or the presence of a classical referred pain pattern. The pressure algometer will then be applied perpendicular to the trigger point. The subject will be asked to report when he/she first feels discomfort. The compression will then be stopped, and the value on the algometer screen will be recorded. The average of three readings, with an interval of 1 minute between the trials, will be recorded. Assessment of pain, function,endurance and pain pressure threshold will be performed pre- and post-treatment. 
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