| CTRI Number |
CTRI/2025/10/096343 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To compare the immediate effects of Integrated Neuromuscular Inhibition Technique and Passive Stretching Technique in upper trapezius trigger points on pain and range of motion of neck in adults. |
|
Scientific Title of Study
|
To compare the immediate effects of Integrated Neuromuscular Inhibition Technique and Passive Stretching Technique in upper trapezius trigger points on pain and range of motion of neck in adults: a randomized clinical 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 |
Saloni Keer |
| Designation |
Graduate student |
| Affiliation |
Dr. Ulhas Patil College Of Physiotherapy |
| Address |
Dr. Ulhas Patil College Of Physiotherapy NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road
Dr. Ulhas Patil College Of Physiotherapy NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
8779298435 |
| Fax |
|
| Email |
saloni.keer1706@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Benade Soniya Sanju |
| Designation |
Professor |
| Affiliation |
Dr. Ulhas Patil College Of Physiotherapy |
| Address |
NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road Tal and Dist Jalgaon
NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road Tal and Dist Jalgaon
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
8660394481 |
| Fax |
|
| Email |
soniyabenade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saloni Keer |
| Designation |
Graduate student |
| Affiliation |
Dr. Ulhas Patil College Of Physiotherapy |
| Address |
Dr. Ulhas Patil College Of Physiotherapy NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road
Dr. Ulhas Patil College Of Physiotherapy NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
8779298435 |
| Fax |
|
| Email |
saloni.keer1706@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrBenade Soniya Sanju |
| Address |
Dr. Ulhas Patil College Of Physiotherapy NH 06 gate no 57/1 Khirdi Shivar Bhusawal Jalgaon road Jalgaon 425309 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Saloni Keer |
Dr. Ulhas Patil College Of Physiotherapy and Hospital |
OPD no 207,Physiotherapy OPD Dr. Ulhas Patil College Of Physiotherapy, NH 06 gat 57/1, Khirdi Shivar, Jalgaon Bhusawal road, Jalgaon 425309
Jalgaon
MAHARASHTRA |
8779298435
saloni.keer1706@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr. Ulhas Patil College Of Physiotherapy |
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 |
Integrated Neuromuscular Inhibition Technique |
1 Ischemic Compression 5 sec of deep pressure and 2 to3 sec of release Repeat this until a noticeable change is felt in upper trapezius 2 Strain counterstrain head bent towards affected side with corresponding arm in flexion abduction and external rotation maintain the position for 20 to 30 secs and repeat 3 to 4 times 3 Muscle Energy Technique(MET) isometric contraction held for 7 to 10 secs followed by relaxation and incremental stretch of muscles with 30 sec hold and repeat 3 to 4 times |
| Comparator Agent |
Passive Stretching |
Manual Stretch by depressing the shoulder and laterally flex the head maintain the stretch for 20 to 30 secs and then relax and repeat it for 2 to 3 times |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must be between 18 and 25 years old.
2. Neck pain in the upper trapezius muscles must have lasted less than three months.
3. Active trigger points must be present in the upper trapezius muscles, according Simons Criteria.
4. Participants must experience unilateral or bilateral neck pain accompanied by muscle spasm and tenderness.
5. Pain intensity must be rated between 4 to 7 on Visual Analogue Scale(VAS). |
|
| ExclusionCriteria |
| Details |
1. Trauma or injuries to the cervical spine, upper back, shoulder.
2. Pre-existing pathological conditions.
3. Neurological conditions like, Cervical radiculopathy, myelopathy, spinal cord injury, CVA, etc.
4. Any surgery of upper back, neck, shoulder within the past year.
5. Degenerative joint disorders in the cervical spine.
6. Autoimmune disorders like Rheumatoid arthritis, lupus, etc.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale(VAS)
|
Intervention is given for immediate effects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Universal Goniometer |
Intervention is given for immediate effects |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
26/10/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Neck pain is a common musculoskeletal condition that affects about one third of adults and reduces their quality of life. A major cause is myofascial pain syndrome which is linked to trigger points. Trigger points are small painful nodules in muscle fibers that feel hard on touch and cause local or referred pain, often spreading to other areas. They are found mainly in muscles such as the upper trapezius, levator scapulae, and infraspinatus. Trigger points may be active, causing pain at rest and during palpation, or latent, which only cause pain or stiffness when pressure is applied. Common signs include tenderness, tightness, reduced motion, fatigue, and referred pain, often related to poor posture and muscle overuse. Various treatments are used to relieve myofascial trigger points such as needling, integrated neuromuscular inhibition techniques, stretching, laser therapy, kinesio taping, and spray and stretch methods. The integrated neuromuscular inhibition technique is a manual therapy that combines ischemic compression, strain counter strain, and muscle energy techniques. It helps relieve trigger point pain by improving blood flow, reducing muscle tension, and promoting relaxation, leading to better pain relief, function, and range of motion. Stretching improves flexibility and range of motion by lengthening tight soft tissues. The main types are static, dynamic, and pre-contraction, with static stretching being most common. It involves holding a muscle under tension and can be done passively or actively. Active stretching, done independently, is preferred as it is safe, low cost, and easy to practice, while also helping improve movement and reduce stiffness. |