| CTRI Number |
CTRI/2026/03/106388 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| 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
|
Effect of Physiotherapy on Headache frequency in Migraine patients |
|
Scientific Title of Study
|
Development, Validation and Feasibility Testing of a Comprehensive Physiotherapy Protocol for the treatment of Migraine Headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Jain |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala
Ambala
HARYANA
133207
India |
| Phone |
7986173842 |
| Fax |
|
| Email |
jainshw44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Jain |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala
Ambala
HARYANA
133207
India |
| Phone |
7986173842 |
| Fax |
|
| Email |
jainshw44@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Ist floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shweta Jain |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Haryana, India, 133207 |
| 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 |
| Shweta Jain |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
General OPD,Room no. 1, Ist floor, Maharishi Markandeshwar Institute ofPhysiotherapy and Rehabilitation, Mullana-Ambala
Ambala
HARYANA |
7986173842
jainshw44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Physiotherapy protocol |
Patient education, exercises, manual therapy and modalities for pain relief |
| Comparator Agent |
Control |
Medical management of migraine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with migraine without aura diagnosed by neurologist based on criteria of ICHD 3rd edition given by Headache Classification Committee of the International Headache Society
2. Migraine attacks should occur 2-8 times per month
3. Migraine must be present for atleast 1 year
4. Able to understand English and follow simple commands
|
|
| ExclusionCriteria |
| Details |
1. Participants presented with any other type of migraine or headache
2. Participants with any Psychiatric conditions like depression, anxiety, schizophrenia, hypnosis, mania, bipolar disorders, etc.
3. Any history of neck or head trauma, skull defects
4. Pregnant and lactating women
5. Any history of surgery around neck or head regions
6. Any systemic degenerative disease, e.g., rheumatoid arthritis, lupus erythematosus, Fibromyalgia syndrome
7. Anaesthetic block in the previous 6 months
8. Receiving any treatment in neck or head area in past 6 months
9. Uncontrolled Blood pressure
10. History of any neurological disorder like epilepsy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Migraine Headache frequency, intensity and duration |
On 1st day before treatment, after 3 weeks and 6 weeks post-treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Migraine Disability Assessment Questionnaire |
On 1st day before treatment, after 3 weeks and 6 weeks post-treatment |
| Migraine Specific Quality of life |
On 1st day before treatment, after 3 weeks and 6 weeks post-treatment |
Pain pressure threshold
|
On 1st day before treatment, after 3 weeks and 6 weeks post-treatment |
| Patient Satisfaction Questionnaire |
On 1st day before treatment, after 3 weeks and 6 weeks post-treatment |
|
|
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)
|
19/04/2026 |
| 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="2"
Months="0"
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
Modification(s)
|
Background: Migraine headache is the 3rd most disabling and complex neurological condition, with a high prevalence of 10 to 12%, affecting the health, lifestyle, and quality of life of people and requiring proper comprehensive treatment to reduce disability and economic burden. Purpose: Development, validation, and feasibility testing of a comprehensive physiotherapy protocol on headache intensity, duration, frequency, disability, pain pressure threshold, quality of life, and patient satisfaction in migraine headache. Methodology: The study will be conducted in a multi-specialty hospital where the procedure of the study will be divided into three phases: formulation of a comprehensive physiotherapy protocol, validation of the developed protocol, and checking the effectiveness of the protocol by performing a randomized control trial on migraine headache patients. All participants will be assessed pre- and post-treatment at baseline and at the end of 3 weeks and 6 weeks with outcome measures for headache intensity, frequency, and duration. The Migraine Disability Assessment Questionnaire, migraine specific-quality of life, pressure pain threshold, and patient satisfaction questionnaire will also be assessed at the end of treatment at the 3rd week and 6th week. The duration of intervention would be 3 days a week for 6 weeks. Results: Content validation will be determined according to the content validity index (CVI) values. Data analysis will be done by using appropriate methods. The significance level will be set at P < 0.05.
Discussion: The results obtained upon completion of this study may provide efficacy of comprehensive physiotherapy protocol on outcomes in patients with migraine headache. |