| CTRI Number |
CTRI/2025/11/097130 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| 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
|
Effect of stretching vs soft tissue release tool on neck pain |
|
Scientific Title of Study
|
Short Term Effect of Instrument Assisted Soft Tissue Mobilization Versus Static Stretching
of Levator Scapulae on Pain, Range of Motion, Functional Disability in Subjects with Mechanical
Neck Pain’ – A Comparative 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 |
Priyanka Tripathi |
| Designation |
Post Graduate Student |
| Affiliation |
D Y Patil Deemed to be University, School of Physiotherapy |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,
6th Floor, Plot No-2. Sector-5, Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9821052637 |
| Fax |
|
| Email |
priyanka1234tri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranita Ganjave |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil Deemed to be University, School of Physiotherapy |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,
6th Floor, Plot No-2. Sector-5, Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9664821336 |
| Fax |
|
| Email |
pranita.ganjave@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranita Ganjave |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil Deemed to be University, School of Physiotherapy |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,
6th Floor, Plot No-2. Sector-5, Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9664821336 |
| Fax |
|
| Email |
pranita.ganjave@dypatil.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priyanka Tripathi |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,
6th Floor, Plot No-2. Sector-5, Nerul, Navi Mumbai-400706 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Priyanka Tripathi |
Dr. D Y Patil Hospital |
Ayyappa temple Rd, Dr. D Y Patil Vidyangar, sec 5, Nerul, Navi mumbai, Maharashtra, 400706
Thane
MAHARASHTRA |
9821052637
priyanka1234tri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with mechanical neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
For Group A (Conventional group):
Static Stretching with Cervical Mobility Exercises
For Group B (Experimental group):
Instrument Assisted Soft Tissue Mobilization with Cervical Mobility Exercises |
Group A (Conventional group) will receive static stretching along with cervical mobility exercises, including flexion, extension, lateral flexion, and rotation. Each mobility exercise will be performed for 10 repetitions in one set. Group B (Experimental group) will receive cervical mobility exercises in addition to Instrument Assisted Soft Tissue Mobilization (IASTM) using the stroking technique, applied for 2–3 minutes in one set. |
| Comparator Agent |
Group A (Conventional group): Static Stretching with Cervical Mobility Exercises |
Group A (Conventional group) will receive static stretching along with cervical mobility exercises, including flexion, extension, lateral flexion, and rotation. Each mobility exercise will be performed for 10 repetitions in one set |
| Comparator Agent |
Group B (Experimental group): Instrument Assisted Soft Tissue Mobilization with Cervical Mobility Exercises |
Group B (Experimental group) will receive cervical mobility exercises in addition to Instrument Assisted Soft Tissue Mobilization (IASTM) using the stroking technique, applied for 2–3 minutes in one set. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with tightness of levator scapulae muscle.
2. Individuals with mechanical neck pain
3. Both males and Females.
4. Individuals willing to participate
|
|
| ExclusionCriteria |
| Details |
1.Individuals with any other musculoskeletal conditions.
2.Individuals who have had recent surgery or injury to the neck and upper limb.
3.Individuals with cervical radiculopathy.
4.Individuals not willing to participate
|
|
|
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 |
1. Cervical Range Of Motion (CROM)
2.Levator scapulae index (LSI) |
2 time points
1. Baseline
2. Post 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numerical rating scale
|
2 time points
1. Baseline
2. Post 2 weeks
|
| Neck disability index |
2 time points
1. Baseline
2. Post 2 weeks
|
|
|
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)
|
19/11/2025 |
| 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 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
|
Mechanical neck pain is a common problem causing pain, reduced mobility, and functional disability, often linked to poor posture and repetitive strain. This study compares the short-term effects of static stretching and instrument assisted soft tissue mobilization (IASTM) of the levator scapulae in individuals with mechanical neck pain. Participants were divided into two groups, one receiving static stretching with cervical mobility exercises and the other receiving IASTM with mobility exercises. Pain, cervical range of motion, and functional disability were assessed using the Numerical rating scale, Cervical range of motion device (CROM), and the Neck Disability Index (NDI). The results aim to determine which intervention is more effective in providing short-term relief and functional improvement. |