| CTRI Number |
CTRI/2026/02/103312 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| 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
|
special technique of stretching of the muscles which are the shorten one exercise which is working on tissue and muscles with instrument which is used for release of the shorten muscles in patient who are suffering from neck pain |
|
Scientific Title of Study
|
“Comparative Effects of Integrated Neuromuscular Inhibition Technique (INIT) and
Instrument-Assisted Soft Tissue Manipulation (IASTM) on Pain, Cervical Range of Motion and Functional
Disability Among College Students with Upper Trapezius Myofacial Trigger Points : A Randomized
Controlled Trial" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanket Parekh |
| Designation |
Associate Professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
Dept No 152 Physiotherapy Dept K M patel Institute of Physiortherapy Bhaikaka University Gokalnagar
Physiotherapy dept No 152 K M Patel Institute of Physiotherapy Bhaiakaka University Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Parekh |
| Designation |
Associate Professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
Dept No 152 Physiotherapy Dept K M patel Institute of Physiortherapy Bhaikaka University Gokalnagar
Physiotherapy dept No 152 K M Patel Institute of Physiotherapy Bhaiakaka University Karamsad
GUJARAT
388325
India |
| Phone |
9879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Parekh |
| Designation |
Associate Professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
Dept No 152 Physiotherapy Dept K M patel Institute of Physiortherapy Bhaikaka University Gokalnagar
Physiotherapy dept No 152 K M Patel Institute of Physiotherapy Bhaiakaka University Karamsad
GUJARAT
388325
India |
| Phone |
9879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Site no 152 Dept of Physiotherapy K M Patel Institute of Physiotherapy Bhaikaka University Gokalnagar Karamsad |
|
|
Primary Sponsor
|
| Name |
No Sponser |
| Address |
No Sponser |
| Type of Sponsor |
Other [NIl] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanket Parekh |
K M Patel Institute of Physiotherapy |
Kinesiotherapy UNit no 152 Dept of Physiotherapy K M Patel Institute of Physiotherapy Bhaikaka University Karamsad
Anand
GUJARAT |
09879352362
sanketkp@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -2 Bhaikaka University Karamsad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IATSM |
this is one kind of instrument based therapy where specialised instrument are applied to reduce the spasm of the muscle |
| Comparator Agent |
INNIT technique |
This is specialised technique of exercises where therapist manipulate the muscles to reduce the spasm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
College students of both genders
Presence of Muscle Trigger Points either in unilateral or bilateral Upper trapezius.
Chronic neck pain lasting more than 3 months
Restricted cervical range of motion (ROM) associated with trigger points |
|
| ExclusionCriteria |
| Details |
Shoulder instability or history of shoulder fractures
History of cancer, malignancy, or serious systemic pathology Neurological disorders affecting the cervical or upper limb region History of cervical trauma, surgery (past 6–12 months), or degenerative joint disease
Previous trigger point injections in the past 6 months Clinical signs of nerve root involvement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS for pain |
outcome will be taken before starting exercise and immediatly after completing the exercise of 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical range of motion |
pre exercises that is before starting the exercise outcome will be taken & again after completing the exercise that is at end of 5 sessions of physiotherapy |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
for treating muscles spasm various treatment is available but this new technique there are other instrument based like IATSM which can help to reduce the symptoms but this another specialised exercise like INIT will might help to reduce pain more effectively |