| CTRI Number |
CTRI/2024/07/071238 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Effect of integrated neuromuscular inhibition technique and Myofascial induction therapy on trapezius trigger points: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Effect of Integrated Neuromuscular inhibition technique versus Myofascial induction therapy on trapezius trigger points: 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 |
Soumya S K |
| Designation |
Post Graduate |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Dr.Prabhakar Kore KLE Hospital, Sagar wards physiotherapy OPD Number 39, Nehru Nagar.
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8749074214 |
| Fax |
|
| Email |
soumyask2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Heggannavar |
| Designation |
Professor and Head |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Dr.Prabhakar Kore KLE Hospital, Sagar wards physiotherapy OPD Number 39, Nehru Nagar.
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9945282896 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Soumya S K |
| Designation |
Post Graduate |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Dr.Prabhakar Kore KLE Hospital, Sagar wards physiotherapy OPD Number 39, Nehru Nagar.
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8749074214 |
| Fax |
|
| Email |
soumyask2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher education and Research, Dr Prabhakar Kore hospital, Nehru Nagar, Belagavi 590010, Karnataka, India . |
|
|
Primary Sponsor
|
| Name |
Soumya S K |
| Address |
KLE Academy of Higher education and Research, Dr Prabhakar Kore hospital, Nehru Nagar, Belagavi 590010, Karnataka, India . |
| Type of Sponsor |
Other [Self Sponsored Project] |
|
|
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 Soumya S K |
KAHERs Prabhakar kore Hospital |
KLE Academy of Higher education and Research, Dr Prabhakar Kore hospital, Sagar wards, Physiotherapy OPD no 39, Nehru Nagar, Belagavi 590010, Karnataka, India .
Belgaum
KARNATAKA |
8749074214
soumyask2000@gmail.com |
|
|
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 |
Trapezius Trigger Points |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Neuromuscular Inhibition Technique |
Participants in Group 1 will Integrated Neuromuscular inhibition technique which will be
carried out in 3 sessions per week for 2 weeks
Ischemic compression, Muscle energy technique, and positional release therapy is given to trapezius trigger points |
| Comparator Agent |
Myofascial Induction therapy |
Participants in Group 2 will receive myofascial induction therapy for 3 sessions per week over
2 weeks.
Participants will be seated, Gentle Pressure with longitudinal slides is given on the trapezius trigger points to relax fascial |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are willing to participate.
Participants aged 20 to 40 years.
Participants with myofascial trigger points confirmed through palpation exhibited tenderness in grades 2 and 3.
Visual analog scale greater than or equal to 5
|
|
| ExclusionCriteria |
| Details |
Participants with a history of Neurological disorders, radiculopathy, fibromyalgia, Joint disorders, and fractures.
Participants on medication. |
|
|
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 Neck Range of Motion |
Pain Pressure Threshold and Neck Range of Motion will be assessed in Baseline, Post-treatment after 6 sessions and after 1 month of follow-up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analog scale
Neck Disability Index Questionnaire |
Visual analog scale and Neck disability index will be assessed in Baseline, Post-treatment after 6 sessions, and after 1 month of follow-up
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 MYOFASCIAL INDUCTION THERAPY ON TRAPEZIUS TRIGGER POINTS: A RANDOMIZED CLINICAL TRIAL
Objective -To compare the effectiveness of the Integrated Neuromuscular Inhibition Technique versus Myofascial Induction therapy on trapezius trigger points by using a Visual analog scale, Neck Disability Index in terms of pain and functional activities, Pain pressure threshold and range of motion using pressure algometer and goniometer.
Inclusion Criteria • Participants who are willing to participate. • The study covers participants aged 20 to 40 years. • Participants with myofascial trigger points confirmed through palpation, exhibiting tenderness in grades 2 and 3. • Visual analog scale greater than 5. Exclusion Criteria • Participants with a history of Neurological disorders, radiculopathy, fibromyalgia, Joint disorders, and fractures. • Participants on medication.
Outcome measures 1) Pain Pressure Threshold 2) Neck Range of Motion 3) Visual Analog Scale 4) Neck Disability Index
Procedure Both groups will receive a Hot pack and Interferential therapy for 15 minutes. before the treatment
Group 1: Participants in Group 1 will receive an Integrated neuromuscular inhibition technique which will be carried out in 6 sessions over 2 weeks Group 2 Participants in Group 2 will receive myofascial induction therapy for 6 sessions over 2 weeks. Home protocol and Postural education will be given After 6 sessions and 1 month follow up the post intervention is assessed. The pre-and post-data will be then collected, tabulated, and analyzed
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