| CTRI Number |
CTRI/2025/04/084809 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
neck mobilization and strengthening exercises for migraine patients |
|
Scientific Title of Study
|
EFFECTIVENESS OF UPPER CERVICAL SPINE MOBILIZATION AND NECK STRENGHTENING EXERCISES IN MIGRAINE PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supreet Kaur |
| Designation |
PG student |
| Affiliation |
SGT University |
| Address |
SGT University, Budhera, Gurugram
Faculty of Physiotherapy
Gurgaon
HARYANA
122505
India |
| Phone |
9871623099 |
| Fax |
|
| Email |
ksupreet659@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snigdha Tiwari |
| Designation |
Assissant Professor |
| Affiliation |
SGT University |
| Address |
SGT University, Budhera , Gurugram
Faculty of Physiotherapy
Gurgaon
HARYANA
122505
India |
| Phone |
9893533630 |
| Fax |
|
| Email |
Snigdha_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snigdha Tiwari |
| Designation |
Assissant Professor |
| Affiliation |
SGT University |
| Address |
SGT University, Budhera , Gurugram
Faculty of Physiotherapy
Gurgaon
HARYANA
122505
India |
| Phone |
9893533630 |
| Fax |
|
| Email |
Snigdha_fphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Supreet Kaur |
| Address |
SGT University, Budhera , Gurugram-122505 |
| 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 |
| Supreet Kaur |
SGT Hospital |
Physiotherapy department , room no. 13
Gurgaon
HARYANA |
9871623099
ksupreet659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MIGRAINE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NECK MOBILIZATION |
1. Central posteroanterior mobilization
2. Unilateral posteroanterior mobilization
3. Unilateral transverse force
|
| Intervention |
NECK STRENGTHENING EXRECISES |
Neck stretching
Neck isometric exercise
Hold - 5 secs
Repetitions – 2*6
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having migraine based in ICHD
|
|
| ExclusionCriteria |
| Details |
1. Malignancy, pregnancy, cerebrovascular disease, degenerative CNS
2. Diagnosis of depression or any psychiatric disease
3. Serious systemic infection
4. Change in medication for migraine within 3 months
5. Having physiotherapy treatment for migraine up to 3 months prior to the start of the study
6. Bilateral headache
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Headache impact test -6
2. Migraine specific quality of life questionnaire
3. VAS
|
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. ROM assessment – inclinometer
2. CV angle assessment |
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)
|
25/04/2025 |
| 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="2"
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
|
This study explores how effective upper cervical spine mobilization and neck strengthening exercises are in reducing the frequency, intensity, and duration of migraines. These techniques aim to improve neck function, alleviate muscle tension, and enhance overall posture, potentially leading to better migraine management. |