| CTRI Number |
CTRI/2025/08/092758 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Buteyko Breathing Technique On Migraine |
|
Scientific Title of Study
|
Effect Of Buteyko Breathing Technique On Heart Rate Variability And Outcomes Of Migraine -A 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 |
Dr Shruti Mankar |
| Designation |
Assistant Professor |
| Affiliation |
PES Modern College of Physiotherapy |
| Address |
2nd floor, Dilkhush Bunglow,Galli No.1
Near Jijayi Garden
Tapodham Parisar
Warje Department of Cardiovascular & Respiratory Physiotherapy,
1186,Shivajinagar,Off.J.M.Road,
Pune-411005 Pune MAHARASHTRA 411052 India |
| Phone |
7276020635 |
| Fax |
|
| Email |
mankarshrutee@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shruti Mankar |
| Designation |
Assistant Professor |
| Affiliation |
PES Modern College of Physiotherapy |
| Address |
2nd Floor,Dilkhush Bunglow, Galli No-1, Near Jijayi Garden Tapodham Parisar Warje Department of Cardiovascular & Respiratory Physiotherapy, PES Modern College of Physiotherapy, 1186,Shivajinagar,Off.J.M.Road,Pune-411005 Pune MAHARASHTRA 411052 India |
| Phone |
7276020635 |
| Fax |
|
| Email |
mankarshrutee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shruti Mankar |
| Designation |
Assistant Professor |
| Affiliation |
PES Modern College of Physiotherapy |
| Address |
2nd Floor, Dilkhush Bunglow, Galli no 1 Near Jijayi Garden Tapodham Parisar Warje Department of Cardiovascular & Respiratory Physiotherapy, PES Modern College of Physiotherapy, 1186,Shivajinagar,Off.J.M.Road,Pune-411005 Pune MAHARASHTRA 411052 India |
| Phone |
7276020635 |
| Fax |
|
| Email |
mankarshrutee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shruti Mankar |
| Address |
PES Modern College of Physiotherapy JM Road Shivajinagar |
| 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 Shruti Mankar |
Agrawal Hospital |
Neuromedicine OPD, Agrawal Hospital, sai colony, 53, karve nagar rd,sramik vasahat, karve nagar, pune - 411052 Pune MAHARASHTRA |
7276020635
mankarshrutee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr.D.Y.Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G890||Central pain syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko Breathing Technique |
Buteyko Breathing is a breath retraining method, taught to the patient which is to be practiced twice daily for 25-30 minutes for 6 weeks. |
| Comparator Agent |
Routine Pharmacological Medicine as prescribed |
Participants shall receive routine medicines as prescribed by their physicians |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Diagnosed With Migraine For At least 2 Years
Patients Who are Willing To Be A part Of This Study
|
|
| ExclusionCriteria |
| Details |
Patient With Neurological Disease Like Head Trauma, Seizure, Encephalitis, Meningitis
Patients With Any Cardiovascular or Respiratory Conditions And Recent Abdominal Surgeries
Pregnant Females And Lactating Mothers
Patients Who Are Not Willing To Be A Part Of The Study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability
Headache Pain Intensity
Headache Frequency
Quality Of Life
Migraine Disability
|
Day 0 And At The End Of 6 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sleep quality
Perceived Stress |
Day 0 And At The End Of 6 Weeks. |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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)
|
04/09/2025 |
| 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="1" Months="3" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Migraine prevalence is notably increasing among adolescents and young adults, significantly compromising their quality of life . Headache disorders particularly migraine have very large detrimental effect on public health and productivity. One of the commonest risk factor associated with migraine are Insufficient sleep and stress. Considering the growing burden of migraine , there is a growing need for safe, non-pharmacological treatments that can complement or even reduce reliance on traditional medications. Buteyko breathing is one of the ancient breath retraining strategies used profoundly in conditions like asthma, COPD, Stress and Hypertension, is known to effective in therapeutic management of these conditions and improving the quality of life. The Non Pharmacological Approach Buteyko Breathing could offer a low-cost, accessible, and sustainable intervention that complements conventional treatment, ultimately improving clinical outcomes and the overall well-being of individuals suffering from migraines. The study shall contain two groups, Experimental Group where Buteyko Breathing shall be taught for 6 weeks along with the routine pharmacological treatment and Control Group which shall continue to receive Pharmacological intervention as prescribed. Outcome measures like Heart Rate Variability, Headache intensity, frequency, quality of life and disability, along with Perceived Stress and Sleep quality , as they are a major risk factor for Migraine. The results of this study could fill a crucial gap in migraine treatment options by providing evidence of a holistic approach that addresses multiple aspects of migraine, including autonomic dysfunction, stress, sleep, and quality of life. |