| CTRI Number |
CTRI/2024/06/069277 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Buteyko Breathing Technique In Reducing Headache. |
|
Scientific Title of Study
|
Effectiveness of Buteyko Breathing Technique in Reducing Tension Type Headache Frequency and Intensity A Randomised Control 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 |
Suvro Nill Sarker |
| Designation |
Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no 527, Department of Physiotherapy and Rehabilitation, Dr.M
R Khan medical center, Jashore university of science and
technology, Jashore, Bangladesh.
7408 Other |
| Phone |
8801622841904 |
| Fax |
|
| Email |
192406.ptr@student.just.edu.bd |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Physiotherapy and Rehabilitation, Dr.M R Khan
medical center, Jashore university of science and technology,
Jashore, Bangladesh.
7408 Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Physiotherapy and Rehabilitation, Dr.M R Khan
medical center, Jashore university of science and technology,
Jashore, Bangladesh.
7408 Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Suvro Nill Sarker |
| Address |
Room no 527, Department of Physiotherapy and Rehabilitation, Dr.M
R Khan medical center, Jashore university of science and
technology, Jashore, Bangladesh. |
| Type of Sponsor |
Other [Self Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kabir Hossain |
Musculoskeletal physiotherapy laboratory |
Department of
Physiotherapy and
Rehabilitation, Dr. M.R
Khan Medical Center,
Room no 302, Jashore
University of Science
and Technology,
Jashore , Bangladesh.
|
8801778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board(IBR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diagnosed Tension Type Headache |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko Breathing |
Nasal Breathing,Breathing Recovery Sitting, Breathing Recovery Walking, Breathe Light, Closed-mouth walking for 10 to 15 minutes daily & Cupping for 6 to 12 times |
| Comparator Agent |
Usual treatment (UT) |
Trigger point release technique, neck muscle strengthening, neck muscle stretching technique a total of 15 to 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Tension headaches of at least one year’s duration.
2.Age limitation from aged 18 to 45 years.
3.Diagnosed with a tension-type headache based on the criteria set forth by the International Headache Society (ICHD-3).
4.Willingness to participate in the study.
5.Able to perform the Buteyko breathing technique
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed with any other primary headache disorder (migraine, cluster headaches etc.).
2.History of head injury or concussion in the past 3 months.
3.Active inflammatory conditions.
4.Participating in any other interventional studies concurrently.
5.Pregnancy or breastfeeding.
6. Active respiratory infection or kidney problems
7. Active respiratory infection or kidney problems
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HIT 6 for measuring frequency and intensity |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pulse rate, respiration rate, and blood pressure |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="0"
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)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [suvronill25@gmail.com].
- For how long will this data be available start date provided 01-11-2024 and end date provided 01-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Effectiveness of Buteyko Breathing technique in Reducing Tension-Type Headache Frequency and Intensity, a Randomized Control Trail. Study Purpose: The study aims to investigate the effectiveness of Buteyko Breathing in reducing tension-type headache frequency and intensity. Tension-Type Headaches: These headaches are characterized by a tight band-like sensation around the head and are triggered by anxiety, head injuries, and stress. Buteyko Breathing Technique: Buteyko Breathing teaches slow and gentle breathing. It has been effective in treating anxiety, asthma, and improving overall well-being. Research Gap: Despite its benefits, no evidence-based study has specifically explored the relationship between tension-type headaches and Buteyko breathing1. |