| CTRI Number |
CTRI/2025/08/093230 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
HOW EFFECTIVE IS CRANIOSACRAL THERAPYFOR MIGRAINES IN YOUNG ADULS HOOKED ON DEVICES? |
|
Scientific Title of Study
|
“Effectiveness of craniosacral therapy in reducing pain intensity and frequency of migraine episodes among young adults with excessive digital gadget use in 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 |
sisiya v s |
| Designation |
POST GRADUATE IN PHYSIOTHERAPY |
| Affiliation |
CAUVERY COLLEGE OF PHYSIOTHERAPY |
| Address |
MPT, NEUROLOGICAL SCIENCES FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028
MPT,NEUROLOGICAL SCIENCES , FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9400975518 |
| Fax |
|
| Email |
sisiyavs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MEGHANA BHANDHARKAR |
| Designation |
ASSISTANT PROFESSOR DEP. OF PHYSIOTHERAPY |
| Affiliation |
CAUVERY COLLEGE OF PHYSIOTHERAPY |
| Address |
MPT,NEUROLOGICAL SCIENCES , FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9606892822 |
| Fax |
|
| Email |
mbhandarkar231@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SISIYA V S |
| Designation |
POST GRADUATE IN PHYSIOTHERAPY |
| Affiliation |
CAUVERY COLLEGE OF PHYSIOTHERAPY |
| Address |
MPT, FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028
MPT, FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9400975518 |
| Fax |
|
| Email |
sisiyavs@gmail.com |
|
|
Source of Monetary or Material Support
|
| CAUVERY COLLEGE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
CAUVERY COLLEGE OF PHYSIOTHERAPY |
| Address |
MPT, FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028 |
| Type of Sponsor |
Other [PRIVATE 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 |
| DrMeghana bhandharkar |
CAUVERY COLLEGE OF PHYSIOTHERAPY OPD |
MPT, FIRST FLOOR , ROOM NO:1 , CAUVERY COLLEGE OF PHYSIOTHERAPY , KBL LAYOUT , NEAR DEVEGOWDA CIRCLE, MYSORE 570028
Mysore
KARNATAKA |
9656567522
mbhandarkar231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| cauvery hospital ethical commitiee mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
migraine |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
craniosacral therapy |
Participants received five techniques in sequence:
Suboccipital inhibition – Hands under occiput with pressure to relax suboccipital muscles (10 min).
Frontal technique – Gentle pressure to frontal bone to relax pericranial tissues (5 min).
Sphenoid technique – Gentle distraction on sphenoid and cranial structures (5 min).
Fourth ventricle technique – Cephalic traction under occiput to influence autonomic balance and reduce pain (10 min).
Lumbosacral technique – Compression between sacrum and pelvis to relax lumbosacral structures (5 min).
|
| Comparator Agent |
placebo intervention |
a hands on placebo superficial contact was performed by placing both hand palms under the occiput for 10 minutes with out touching the suboccipital muscle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1.Age group between 18-27 Including both male and female
2.More than one year history of migraine
3.Three or more episodes per month
4.Migraine causing due to overuse of computer and smart phone.
5.Those who have family background with migraine.(genetic)
6.Subjects which fulfill the MS-Q were included |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1.Cervicogenic headache
2.Vertigo
3.Menstruation associated migraine
4.Spinal radiculopathy
5.Temperomandibular disorders
6.Patients who have not received any previous manual therapy treatment for migraine. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Digital Media Overuse Scale dMOS |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale VAS |
1 minute |
| .Migraine screening questionnaire MS- Q |
1 minute |
|
|
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)
|
31/08/2025 |
| 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="3"
Days="2" |
|
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
|
This study will investigate the effectiveness of Craniosacral Therapy CST in reducing pain intensity and frequency of migraine episodes among young adults who overuse digital gadgets. Migraines, often triggered by prolonged computer and smartphone use, will be assessed in individuals aged 18–27 years. Participants will be screened using the Migraine Screening Questionnaire MS-Q and the Digital Media Overuse Scale dMOS, and then randomly allocated into two groups: an experimental group receiving CST and a control group receiving a placebo intervention.
The CST group will undergo five standardized techniques – suboccipital inhibition, frontal, sphenoid, fourth ventricle, and lumbosacral techniques – delivered over four weeks. The placebo group will receive a sham intervention involving only superficial contact without therapeutic pressure.
Outcome measures will include the Visual Analogue Scale VAS for pain intensity and the MS-Q for migraine frequency, recorded at baseline, after four weeks of treatment, and at an eight-week follow-up. Data will be statistically analyzed to determine within-group and between-group differences.
It is anticipated that CST will lead to a significant reduction in migraine pain intensity and frequency of episodes compared to placebo treatment, thereby establishing CST as an effective non-pharmacological intervention for migraine management in young adults who overuse digital gadgets.
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