| CTRI Number |
CTRI/2026/01/102545 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| 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
|
Study Comparing Bowen Therapy and Myokinetic Stretching in people with headache |
|
Scientific Title of Study
|
Effect of Bowen Therapy versus Myokinetic Stretching on Pericranial Muscle Dysfunction in Individuals with Tension-Type Headache: 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 |
Sudarshan Shewale |
| Designation |
Postgraduate student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Department of Physiotherapy,
Faculty of Physiotherapy,
Parul Institute of Physiotherapy,
Room No - No applicable
Parul University Campus,
Limda, Waghodia Road,
Vadodara, Gujarat.
Vadodara GUJARAT 391760 India |
| Phone |
8421875802 |
| Fax |
|
| Email |
rajsheale@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sudarshan Shewale |
| Designation |
Postgraduate student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Department of Physiotherapy,
Faculty of Physiotherapy,
Parul Institute of Physiotherapy,
Room No - Not Applicable,
Parul University Campus,
Limda, Waghodia Road,
Vadodara, Gujarat.
Vadodara GUJARAT 391760 India |
| Phone |
8421875802 |
| Fax |
|
| Email |
rajsheale@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sudarshan Shewale |
| Designation |
Postgraduate student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Department of Physiotherapy,
Faculty of Physiotherapy,
Parul Institute of Physiotherapy,
Room No- Not Applicable,
Parul University Campus,
Limda, Waghodia Road,
Vadodara, Gujarat.
Vadodara GUJARAT 391760 India |
| Phone |
8421875802 |
| Fax |
|
| Email |
rajsheale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-funded study with academic support from
Department of Physiotherapy,
Faculty of Physiotherapy,
Parul Institute of Physiotherapy,
Parul University Campus,
Limda, Waghodia Road,
Vadodara – 391760,
Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Parul university |
| Address |
Parul University,
Faculty of Physiotherapy,
Parul Institute of Physiotherapy,
Parul University Campus,
Limda, Waghodia Road,
Vadodara – 391760,
Gujarat, India. |
| Type of Sponsor |
Private medical college |
|
|
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 Sudarshan Shewale |
PARUL SEVASHRAM HOSPITAL |
Department of Physiotherapy,
Faculty of Physiotherapy,
Parul Institute of Physiotherapy,
Room No. Not Applicable,
Parul University Campus,
Limda, Waghodia Road,
Vadodara – 391760,
Gujarat, India. Vadodara GUJARAT |
8421875802
2407202080025@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee For Human Research (PU-IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G442||Tension-type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bowen Therapy |
Participants allocated to Group A will receive Bowen Therapy targeting pericranial and associated cervical musculature.
The intervention will be administered by a trained physiotherapist on alternate days for a duration of 2 weeks.
Each treatment session will last approximately 20 minutes.
A total of 6 treatment sessions will be delivered during the intervention period.
|
| Comparator Agent |
Myokinetic Stretching Technique |
Participants allocated to Group B will receive Myokinetic Stretching Technique focusing on pericranial and associated cervical muscles.
The intervention will be administered by a trained physiotherapist on alternate days for a duration of 2 weeks.
Each session will consist of 4 sets of 15 stretches with intermittent rest of 3 minutes between sets.
A total of 6 treatment sessions will be delivered during the intervention period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1) Both male and female students in the age group 18-28 years
2) Bilateral location
3) Recurrent mild to moderately intense headaches
4) Headaches that feel pressing or tightening
5) No episodes of nausea or vomiting during headache
6) No exacerbation with ordinary physical activity
7) Headache Disability Index score ranging from 10-48 (mild to moderate)
|
|
| ExclusionCriteria |
| Details |
1) Subjects with other types of headache like migraine or cervicogenic headache
2) Any co morbid factors like congenital, malignant, autoimmune and neurological conditions involving head and neck
3) Any trauma to head and neck region less than 6 months
4) Any diagnosed systemic illness
5) Individuals on medication for tension type headache
|
|
|
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 |
| Pain intensity measured using Visual Analogue Scale |
Baseline and at the end of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Headache related Disability measured using Headache Disability Index |
Baseline and at the end of intervention |
| Cervical Range of Motion measured using Goniometer |
Baseline and at the end of intervention |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
15/02/2026 |
| 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="6" Days="0" |
|
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
|
Tension type headache is one of the most common primary headaches and is associated with pericranial muscle tenderness and functional disability. Physiotherapy interventions are commonly used to reduce pain and improve function in individuals with tension type headache. Bowen therapy and myokinetic stretching technique are manual therapy approaches used for musculoskeletal conditions, but evidence comparing their effectiveness in tension type headache is limited. This randomized parallel group active controlled trial aims to evaluate and compare the effect of Bowen therapy versus myokinetic stretching technique on pain intensity, headache related disability, and cervical range of motion in individuals with tension type headache. A total of 38 participants will be randomly allocated into two groups using envelope method. One group will receive Bowen therapy and the other group will receive myokinetic stretching technique. Outcome measures will include pain intensity measured using Visual Analog Scale, headache related disability measured using Headache Disability Index, and cervical range of motion measured using goniometer. Assessments will be performed at baseline and at the end of intervention. The findings of this study may help in identifying an effective physiotherapy intervention for the management of tension type headache. |