| CTRI Number |
CTRI/2025/06/089380 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Soft Tissue Therapy on Pain and Neck Movement in People with Common Neck Pain |
|
Scientific Title of Study
|
Immediate Effects of Instrument Assisted Soft Tissue Mobilization (IASTM) on Pain, Range of Motion and Neck Function in Patients with Non-Specific Neck Pain: An Experimental 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 |
Rajas Parag Mudey |
| Designation |
Postgraduate |
| Affiliation |
Nagar Yuvak Shikshan Sanstha, Datta Meghe College of Physiotherapy |
| Address |
Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9665666164 |
| Fax |
|
| Email |
rajasmudey123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Deshmukh |
| Designation |
associate professor |
| Affiliation |
Nagar Yuvak Shikshan Sanstha, Datta Meghe College of Physiotherapy |
| Address |
Datta meghe College of Physiotherapy Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8888826093 |
| Fax |
|
| Email |
nehadeshmukh57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajas Parag Mudey |
| Designation |
Postgraduate |
| Affiliation |
Nagar Yuvak Shikshan Sanstha, Datta Meghe College of Physiotherapy |
| Address |
Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9665666164 |
| Fax |
|
| Email |
rajasmudey123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe College Of Physiotherpy Nagpur |
| Address |
Department of Musculoskeletal Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur, Maharashtra 441110 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajas Parag Mudey |
Shalinitai Meghe Hospital and Research Center ,Nagpur |
Department-Musculoskeletal Department, OPD ROOM no.1, Datta Meghe College of Physiotherapy, Wanadongri Hingna Road Nagpur-441110
Nagpur
MAHARASHTRA |
9665666164
rajasmudey123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nagar Yuvak Sanstha, Datta Meghe college of Physiotherapy,Nagpur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
IASTM |
on 1st day- patients position - prone, IASTM used for 30 seconds to 1 minute, at 45 degrees angle
on 2nd day - active neck exercises |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-specific neck pain
Patients with score 6 or more than 6 on Numeric Pain Rating Scale (NPRS)
Men and women between the ages of 18-50 years old
Able to provide informed consent and participate in study
|
|
| ExclusionCriteria |
| Details |
Spinal pathology, ankylosing spondylitis, any open wound around the neck, history of cervical fracture, torticollis and any other conditions that contraindicate Rockblade
Any recent surgeries around neck
Individuals with recent muscle strains
Individuals with neurological disorders, cervical radiculopathy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
Range of Motion
Neck Disability Index |
pre treatment
immediately post treatment
after 48 hours of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
11/07/2025 |
| 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="1"
Months="0"
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
|
Non-specific neck pain (NSNP) is a widespread musculoskeletal issue that significantly impacts daily function and quality of life. Characterized by pain in the cervical region without an identifiable cause, NSNP often results from factors like poor posture, prolonged screen time, or muscular imbalances. Although conservative treatments exist, the effectiveness of various manual therapy techniques remains under debate. Instrument-Assisted Soft Tissue Mobilization (IASTM) is a manual therapy that uses specialized tools to address soft tissue restrictions. It promotes tissue healing through controlled mechanical stimulation, which improves blood flow, breaks down adhesions, and enhances muscle flexibility. Despite growing popularity, limited research has explored the immediate effects of IASTM on pain, range of motion (ROM), and neck function in NSNP populations. This study investigates the immediate and short-term (48-hour) impact of IASTM using the Rockblade tool on adults with NSNP. Outcome measures include the Numeric Pain Rating Scale (NPRS), cervical ROM via goniometry, and the Neck Disability Index (NDI). The study aims to provide clinical evidence on the effectiveness of IASTM as a targeted intervention for managing NSNP. |