| CTRI Number |
CTRI/2025/09/094951 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| 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
|
Comparing the effect of two different technique for the treatment of myofascial trapezius trigger point |
|
Scientific Title of Study
|
Effect of Integrated Neuromuscular Inhibition Technique versus Dry cupping and Ischemic Compression on Pain and Function in subjects with Myofascial Trapezius Trigger Point 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 |
Dr Apeksha Hungund |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center room no 39 department of Orthopedic Manual Therapy room no 13 Sagar floor Belagavi Karnataka 590010
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8310725829 |
| Fax |
|
| Email |
apeksha_hungund@kleipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Hungund |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center room no 39 department of Orthopedic Manual Therapy room no 13 Sagar floor Belagavi Karnataka 590010
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8310725829 |
| Fax |
|
| Email |
apeksha_hungund@kleipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kavya S Bharbhari |
| Designation |
Post graduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center room no 39 department of Orthopedic Manual Therapy room no 13 Sagar floor Belagavi Karnataka 590010
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9632247826 |
| Fax |
|
| Email |
ksbharbhari152001@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy Nehru Nagar Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Kavya S Bharbhari |
| Address |
KAHER Institute of Physiotherapy Nehru Nagar Belagavi KARNATAKA
590010
|
| 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 |
| Dr Apeksha Hungund |
KLEs Dr. Prabhakar Kore Hospital and Research centre |
KAHERs Prabhakar Kore Hospital and Research centre, Physiotherapy OPD no 39 Sagar wards, Orthopedic Manual Therapy OPD NO 13, Belagavi Karnataka 590010
Belgaum
KARNATAKA |
08310725829
apeksha_hungund@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myofascial Trapezius Trigger point. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dry cupping and Ischemic Compression |
Participants will receive the combination of Dry cupping and ischemic compression which will be carried out in 3 sessions per week for 2 weeks.
First Ischemic compression will be administered to the trigger point then followed by Cupping therapy, with minimum delay.
The patient will be given five continuous deep pressure compressions for 1 min on the marked Trigger points, with a 1 min rest between every compression. Pressure will be released when the trigger point tension decreases.
The participants will receive Cupping therapy for 10 min on the marked trigger point. The vacuum cup size will be determined according to the area on which the TP will be situated. The cup will be placed on the marked TP followed by a tolerable intensity of pumping. The cup will then be kept on the TP for 10 min.
It will take 20 min to complete one session.
Home program including self-stretching of the upper trapezius for 5 repetitions each repetition is held for 45 seconds, scapular stabilization exercises and a Hot moist pack for 10 minutes.
The assessment will be done at the baseline i.e on the day 1 and after 2 weeks 3 sessions per week and after 1 week of follow up.
|
| Intervention |
Integrated Neuromuscular Inhibition technique |
Participants of this group will receive an Integrated Neuromuscular inhibition technique which will be carried out in 3 sessions per week for 2 weeks. INIT is the combination of three following techniques
Ischemic Compression The patients will be placed in supine position ,the pressure will be applied over a specific trigger point using pincher grip between the thumb and index finger. The applied pressure will be maintained until the pain reduceses. Then, pressure will be applied again until the patient will report discomfort. This procedure will be performed for 90 seconds and will be repeated between three to five times.
Strain counter strain SCS slight pressure will be then applied on a trigger point until pain will be felt this pressure will then be maintained until the position of ease will be identified. In order to position the upper trapezius in a shortened or relaxed position, the patient will be placed into a supine position, and the therapist will side bend the patients head toward the involved side, while positioning the ipsilateral arm in abduction or flexion to reduce tender point pain. Once the position of ease will be achieved, it will be maintained for 20 to 30 seconds and then will be repeated for three times.
Muscle Energy Technique the patient will be asked to simultaneously shrug the involved shoulder toward his/her ear, as well as bringing the ear closer to the shoulder, against resistance. The isometric contraction will be held for 7-10 seconds. Following the contraction, the therapist applies contralateral side bending and ipsilateral rotation to initiate a local tissue stretch, in the tissues in which the trigger point will be located. The stretch will be held for 30 seconds and the procedure will be repeated for three to five times.
Each session will be lasting about 15 to 20 minutes.
Home program including self stretching of the upper trapezius for 5 repetitions each repetition is held for 45 seconds, scapular stabilization exercises and a Hot moist pack for 10 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 All genders of age group 18 to 40 years.
2 Participants with myofascial trigger points confirmed through palpation, exhibiting tenderness levels at grades 2 and 3.
3 Pain on visual Analogue Scale 3 to 7
4 Two to five trapezius trigger points will be assessed on both the right and left side to find out active or latent trigger points.
5 Participants who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1 Neck pain due to trauma, whiplash, cervical disc prolapse, inflammation, infection, malignant disease, or any other neurological and orthopedic conditions.
2 Congenital malformation of the spine as it will alter the normal pattern of movements.
3 Patients with sensory impairments, such as diabetic sensory neuropathy.
4 Any psychological disorder where person might not cooperate for the tretament.
5 If they had received trigger point injections in the upper trapezius muscle within the past 6 months.
|
|
|
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 |
| Pain Pressure Threshold |
Pain Pressure Threshold will be assessed at the baseline on the day 1 and after 6 sessions of 2 weeks and after 1 week of follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale and Neck Disability Index |
will be assessed at the Visual Analogue Scale and Neck Disability Index will be assessed baseline on the day 1 and after 6 sessions of 2 weeks and after 1 week of follow up. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title: Effect of Integrated Neuromuscular Inhibition
Technique versus Dry cupping and Ischemic Compression on Pain and Function
in subjects with Myofascial Trapezius Trigger Point– A Randomized Clinical
Trial
|
Objective: To compare and evaluate the effectiveness of Integrated Neuromuscular
Inhibition Technique versus Dry cupping and Ischemic compression on
Myofascial Trapezius Trigger points by using a Visual analogue scale for
pain, a Neck Disability Index for functional activities, and a pressure algometer for Pain pressure
threshold.
|
Inclusion Criteria:
- All
genders of age group18 to 40 years.
- Participants
with myofascial trigger points confirmed through palpation, exhibiting
tenderness levels at grades 2 and 3.
- Pain
on visual Analogue Scale 3 to 7
- Two
to five trapezius trigger points will be assessed on both the right and
left side to find out active or latent trigger points.
- Participants
who are willing to participate.
|
Exclusion Criteria:
1.
Neck pain due to
trauma, whiplash, cervical disc prolapse, inflammation, infection, malignant
disease, or any other neurological and orthopedic conditions.
2.
Congenital
malformation of the spine as it will alter the normal pattern of movements.
3.
Patients with
sensory impairments, such as diabetic sensory neuropathy.
4.
Any psychological
disorder where person might not cooperate for the treatment.
5.
If they had
received trigger point injections in the upper trapezius muscle within the
past 6 months.
Outcome measures 1. Visual Analogue scale 2. Neck Disability Index 3. Pain Pressure threshold
Procedure Participants of Group
‘A’ will receive an Integrated Neuromuscular inhibition technique which will be
carried out in 6 sessions for 2 weeks. Participants of Group ’B’ will receive the combination of Dry cupping and Ischemic Compression which will be carried out in 6 sessions for 2 weeks. Pre assessment will be done at baseline at day 1 and after 2 weeks and after 1 week of follow up for both the groups.
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