| CTRI Number |
CTRI/2026/01/100640 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| 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
|
Role of Exercises on Pain and muscle activity of neck in People with headache |
|
Scientific Title of Study
|
Effectiveness of Scapular Stabilization Exercises and Integrated Polyvagal Exercises on Pain, Forward Head Posture and EMG activity of the Upper Trapezius and Sternocleidomastoid in Individuals with Cervicogenic Headache : Randomized Controlled 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 |
Akanksha Pal |
| Designation |
Post Graduate Student |
| Affiliation |
SGT UNIVERSITY |
| Address |
SGT UNIVERSITY Room no 415 4th floor department of physiotherapy B block Gurugram Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8303853047 |
| Fax |
|
| Email |
akankshapal313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalli Singh |
| Designation |
Assistant Professor |
| Affiliation |
SGT UNIVERSITY |
| Address |
SGT UNIVERSITY Room no 415 4th floor department of physiotherapy B block Gurugram Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9558386479 |
| Fax |
|
| Email |
lalli_sphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha Pal |
| Designation |
Post Graduate Student |
| Affiliation |
SGT UNIVERSITY |
| Address |
SGT UNIVERSITY Room no 415 4th floor department of physiotherapy B block Gurugram Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8303853047 |
| Fax |
|
| Email |
akankshapal313@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Akanksha Pal |
| Address |
Lane 5 Sarju Nagar Sai Data road Sarsawa Arjunganj Lucknow Uttar Pradesh India 226002 |
| 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 Akanksha Pal |
SGT Hospital and Research Institute |
SGT UNIVERSITY Room no 415 4th floor department of physiotherapy B block Gurugram Haryana 122505
Gurgaon
HARYANA |
8303853047
akankshapal313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of faculty of physiotherapy SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Training |
Conventional exercises is given to control group where neck isometric exercise are given for 10 repetitions of 3 sets each |
| Intervention |
Scapular Stabilization Exercises and Integrated Polyvagal Exercises |
scapular stabilization exercises and integrated polyvagal exercises will be given for the duration of four week (3 sessions in a week) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
Subject diagnosed with cervicogenic headache according to established diagnostic criteria third edition of the International Classification of Headache Disorders (ICHD-3)
History of having neck pain for 3 or more than 3 month |
|
| ExclusionCriteria |
| Details |
Tension-type headaches and migraine
Internal carotid or vertebral artery dissection
Arnold-Chiari malformation
Herniated intervertebral disc
Intramedullary or extramedullary spinal tumor
Spinal nerve compression or tumor
Arteriovenous malformation
Neck-tongue syndrome
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Craniovertebral angle
Muscle activity of upper trapezius and sternocleidomastoid muscle
|
Baseline and 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck disability
Quality of life |
Baseline and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/01/2026 |
| 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="1"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Need of the Study Cervicogenic headache is a secondary form of condition that arises from abnormalities of the cervical region and is recognized globally as a distinct clinical entity Combining scapular stabilization exercises with polyvagal exercises may offer potential synergistic effects in the management of headache symptoms There is dearth of articles in showing effectiveness of scapular stabilization exercises and Integrated polyvagal exercises on pain forward head posture and EMG activity of upper trapezius and sternocleidomastoid muscle in individuals with cervicogenic headache Polyvagal exercises help in reducing pain perception and promote relaxation and emotional well-being This study hypothesized that the combination of these interventions would lead to improved overall outcomes for individuals diagnosed with cervicogenic Significance of the study This study will provide evidence on the effectiveness of Scapular stabilization exercise and Integrated polyvagal exercise on Pain Forward head posture and EMG activity of upper trapezius and sternocleidomastoid muscle in individuals with cervicogenic headache The findings may help in selecting evidence based interventions to improve functional outcome and quality of life
|