| CTRI Number |
CTRI/2025/07/091194 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| 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
|
Effect of soft tissue technique and neck exercises on pain and disability in patients with chronic neck pain |
|
Scientific Title of Study
|
Efficacy of Instrument Assisted Soft Tissue Mobilization along with Cervical Stabilization Exercises on Pain, Pressure Pain Threshold and Neck Pain Disability Index among Patients with 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 |
Prof. Dr Shagun Agrawal |
| Designation |
Dean, School of Allied Health Sciences, Galgotias University |
| Affiliation |
School of Allied Health Sciences, Galgotias University |
| Address |
5th Floor, B Block, Physiotherapy Department, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Uttar Pradesh
5th Floor, B Block, Physiotherapy Department, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
dean.sahs@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr Shagun Agrawal |
| Designation |
Dean, School of Allied Health Sciences, Galgotias University |
| Affiliation |
School of Allied Health Sciences, Galgotias University |
| Address |
5th Floor, B Block, Physiotherapy Department, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
5th Floor, B Block, Physiotherapy Department, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
dean.sahs@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Dr Shagun Agrawal |
| Designation |
Dean, School of Allied Health Sciences, Galgotias University |
| Affiliation |
School of Allied Health Sciences, Galgotias University |
| Address |
5th Floor, B Block, Physiotherapy Department, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
5th Floor, B Block, Physiotherapy Department, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
dean.sahs@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD,Room No. E003, E Block, School of Allied Health Sciences, Galgotias University, PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
OPD Physiotherapy Department No.E003,E Block, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida,Uttar Pradesh |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Galgotias University |
OPD Physiotherapy Department No.E003,E Block, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida,Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Shagun Agrawal |
Galgotias University |
OPD Physiotherapy Department No.E003,E Block, Galgotias PlotNo.2, sector17-A,Yamuna Expressway, Greater Noida,Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9910259583
Dean.sahs@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M624||Contracture of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy treatment |
Control group 69 Participations will Recive Conventional physiotherapy treatmentThe intervention will be Provided three sessions per week for a duration of six weeks. Each session duration 45 minutes. The intervention timeline includes assessments at 6 weeks (baseline from zero day,at 3 weeks, and at 6 weeks post-intervention)
The treatment will specifically focus on the upper trapezius and levator scapulae muscles. Each session will include the following components,
1.Mayofacial Release 20 mints
2.Ice pack 10 mints
3.Cervical Dynamic Excercise 10 mints.
Cervical Extension Dynamic
Isometric 10 sec hold per 10 Repitations.
Cervical Flexion Dynamic Isometric 10sec hold per 10 Repitations.
Cervical Side Flexion Right 10sec hold per 10 Repitations.
Cervical Side Flexion Left 10sec hold per 10 Repitations.
Chest Flys Excercise 10sec hold per 10 Repitations.
4. Stretching Excercise 5 mints
|
| Intervention |
Instrument Assisted Soft Tissue Mobilization with Cervical Stabilization Exercises
|
Intervention Group Protocol
The intervention group 69 participants will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) and Cervical Stabilization Exercises. The intervention will be provided three sessions per week for a duration of six weeks. Each session duration 45 minutes. The intervention timeline includes assessments at 6weeks (baseline day zero, 3 weeks and 6 weeks post-intervention)
The treatment will specifically focus on the upper trapezius and levator scapulae muscles. Each session will include the following components
1. Instrument-Assisted Soft Tissue Mobilization (IASTM) 20 minutes,
2. Cryotherapy (Ice Pack Application) 10 minutes,
3. Cervical Stabilization Exercises 10 minutes,
Chin Tucks Hold for 10 seconds, 10 repetitions
Cervical Extension Hold for 10 seconds, 10 repetitions
Shoulder Shrugs Hold for 10 seconds 10 repetitions,
Shoulder Rolls Hold for 10 seconds 10 repetitions,
Scapular Retractions Hold for 10 seconds, 10 repetitions
4. Stretching Exercises 5 minutes
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Between 20 to 45 Years
2. Diagnosed with Chronic Neck Pain in Both Gender Male And Female Lasting More Than 3 Months
3.Presence Of At Least One Active Myofascial Trigger Point In Cervical Muscles.
4. Pain Score Of More 3 On The Numarical Reating Scale.
5.Willingness To Participate With Informed Consent
6.Participate Will Be Able To Follow Exercise Instructions And Attend All Sessions During The Treatment Period. |
|
| ExclusionCriteria |
| Details |
History of cervical spine surgery or recent trauma
• Neurological Conditions Affecting the cervical region
• Systemic disorders.
• Use of corticosteroids or muscle relaxants
• Pregnant women
• Any malignancy
• Inability to follow treatment protocol or provide consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Rating Scale
Pressure Pain Threshold Algomerer |
Baseline Intervention From Zero Day
Post Intervention in 3 weeks
Recive of Patient Intervention in weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index |
Baseline Intervention From Zero Day
Post Intervention in 3 weeks
Recive of Patient Intervention in weeks |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="1"
Days="1" |
|
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
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dean.sahs@galgotiasuniversity.edu.in].
- For how long will this data be available start date provided 30-07-2027 and end date provided 30-07-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Study Design Randomised Controlled Trial Study Place Study will be conducted in Physiotherapy OPD and Physiotherapy rehabilitation centers in Noida, Study Duration 1Year Sampling Randomisation will be done by Computerised Generated Process All patients will be screened, will be informed about the study Informed consent from patients and Approval from hospital research ethics committee will be taken. Sample Size 138 Participants ,A total of 138 participants diagnosed with chronic neck pain will be recruited for the study. These individuals will be equally divided into two groups • Group A Experimental Group Will Recive IASTM and Cervical Stabilization Excercise • Group B Control Group will Recive Convational physiotherapy Each group will stabilization 69 participants.
Inclusion Criteria 1. Age between 20 to 45 years 2. Diagnosed with chronic neck pain in both gender male and female 3. Presence of at least one active myofascial trigger point in cervical muscles 4. Pain score of more then 3 on the Numarical reating Scale 5.Willingness to participate with informed consent 6.Participate will be able to follow exercise instructions and attend all sessions during the treatment period.
Exclusion Criteria: • History of cervical spine surgery or recent trauma • Neurological conditions affecting the cervical region • Systemic disorders • Use of corticosteroids or muscle relaxants • Pregnant Women • Any Malignancy • Inability to follow treatment protocol or provide consent
Outcome Measures Primary Outcomes 1.Numeric Rating Scale 2.Pressure Pain Threshold
Secondary Outcomes 1. Neck Disability Index Methodology Intervantion 6 weeks, Baseline Intervention from zero day, Post Intervention 3weeks & 6weeks, All interventions will be supervised by trained physiotherapists,
GROUP A Experimental Group 69 Participants Will Recive IASTM and Cervical stabilizer Excercise 3 sessions per a week, Duration of 45 mints per sessions Both group specifically focusing on the upper trapezius and levator scapulae muscles 1.IASTM 20 mints 2.Ice pack 10 mints 3.Neck stabilization excercise 10 mints Chin tuck 10sec hold per 10 repitations Cervical extension10sec hold per 10 repitations Shoulder shrugs 10sec hold per 10 repitations Shoulder rolls10sec hold per 10 repitations scapular Retraction 10sec hold pet 10 repitations 4.. Stretching excercise 5 mints
Group B control group 69 Participations will Recive Conventional physiotherapy treatment,3 sessions per a week, 1.Mayofacial Release 20 mint 2.Ice pack 10 mints 3.Cervical dynamic excercise 10 mints cervical Extension dynamic isometric 10 sec hold per 10 repitations Cervical flexion dynamic isometric 10sec hold per 10 repitations Cervical side flexion right 10sec hold per 10 repitations Cervical side flexion left 10sec hold per 10repitations Chest fly’s excercise 10sec hold per 10repitations 4. Stretching excercise 5 mints
Data Collection Blinded assessor will record pre- and post-treatment data. Statistical Analysis SPSS used. Paired and independent t-tests. p < 0.05. Ethical Approval Approved by IRB. Consent obtained Confidentiality and voluntary participation.
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