| CTRI Number |
CTRI/2026/01/102064 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| 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
|
For people with headaches caused by neck problems does adding fascia therapy to neck Mulligan mobilization reduce pain and improve neck strength and daily activities better than neck Mulligan mobilization alone? |
|
Scientific Title of Study
|
Effectiveness Of Fascial Manipulation With Mulligan’s Mobilization
On Pain, Disability And Endurance Of Deep Cervical Flexors In
Cervicogenic Headache:A Randomized Clinical 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 |
Clifa Vas |
| Designation |
Post graduate of physiotherapy |
| Affiliation |
Institute of physiotherapy, Srinivas University |
| Address |
Institute Of Physiotherapy, Srinivas University, Department Of Musculoskeletal And Sports Physiotherapy ground floor, city campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8007123806 |
| Fax |
|
| Email |
clifavas11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Kamalakannan |
| Designation |
HOD cum Associate Professor |
| Affiliation |
Institute of physiotherapy Srinivas University |
| Address |
Institute Of Physiotherapy, Srinivas University, Department Of Musculoskeletal And Sports Physiotherapy ground floor, city campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
919500931424 |
| Fax |
|
| Email |
kamalakannan.pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Clifa Vas |
| Designation |
Post graduate of physiotherapy |
| Affiliation |
Institute of physiotherapy,Srinivas University |
| Address |
Institute Of Physiotherapy, Srinivas University, Department Of Musculoskeletal And Sports Physiotherapy ground floor, city campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8007123806 |
| Fax |
|
| Email |
clifavas11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Physiotherapy, Srinivas University,ground floor, city campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
|
|
Primary Sponsor
|
| Name |
Clifa Vas |
| Address |
Institute Of Physiotherapy, Srinivas University,ground floor, city campus, Pandeshwar, Mangaluru
Dakshina Kannada 575001 |
| 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 |
| DrClifa Vas |
Institute of Physiotherapy, Srinivas University, MSD, Pandeshwar, Mangaluru 575001 |
Institute Of Physiotherapy, Srinivas University, Department Of Musculoskeletal And Sports Physiotherapy ground floor, city campus, Pandeshwar, Mangaluru 575001
Dakshina Kannada
KARNATAKA |
8007123806
clifavas11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE(IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascial Manipulation |
Fascial Manipulation consists of applying a deep friction with elbows or knuckles over each small area for 3 to 4 in order to create localised hyperaemia in order to resolves a densification minutes along with conventional exercises |
| Intervention |
Mulligans Mobilization |
Mulligans Mobilization technique in which the patient actively moves as the therapist glides over the affected joint includes sustained natural apophyseal glide for 8 minutes with 10 repetition and upper cervical traction for 10 seconds hold with 10 repetition and 3 sets along with conventional exercises |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age group of 18-60 years
Both men and women included.
Subjects who experience frequent headaches.
Subjects who experience unilateral, often on one side of the head and can radiates from the
neck to the head.
On a 11-point pain scale, the intensity of CGH pain should be between 0 to 10
CGH due to cervical spine dysfunction;
Neck pain followed by headache;
Patients who is able to understand English language
Patients with headaches, restricted to perform the daily activities will be included |
|
| ExclusionCriteria |
| Details |
Participants with other types of headache (migraine)
Headaches attributed to other underlying causes, such as:
(Sinus issues, Tumors, Neurological disorders, Temporomandibular joint (TMJ) dysfunction)
and received any type of physical therapy within the past three months
Conditions contraindicating manual or manipulative therapy, including:
(Bone fractures, Joint instability, Osteoporosis, Arthritic disorders, Presence of neurological
symptoms)
Diagnosis of vertebrobasilar artery insufficiency.
Current use of pain medications or corticosteroids
Evidence of cancer metastasis.
Cardiovascular issues, including:
History of stroke, High blood pressure, Episodes of fainting or syncope)
Neurological disorders, such as:
Nerve root compression (radiculopathy),Spinal cord dysfunction (myelopathy),Disc-related
conditions).
Previous surgical procedures involving the brain or spinal cord.
Fractures occurring recently.
Underwent recent surgical operations.
Congenital deformities or abnormalities of the cervical spine.
Lack of willingness to participate in the study.
Subjects without dizziness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale |
Participants will be evaluated at baseline, post-intervention after 4 weeks, and at follow-up visits scheduled at 1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Headache Disability Inventory
Craniocervical Flexion Test |
Participants will be evaluated at baseline, post-intervention after 4 weeks, and at follow-up visits scheduled at 1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/02/2026 |
| 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="0"
Days="6" |
|
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
|
Cervicogenic headache is a secondary headache arising from the upper cervical spine (C1–C3), characterized by unilateral neck pain radiating to the head. This randomized clinical trial compares the effectiveness of Fascial Manipulation with Mulligan’s Mobilization, combined with conventional exercises, in individuals with cervicogenic headache. Participants will be randomly allocated into two groups and treated for four weeks with post-intervention follow-up. Outcome measures include Numerical pain rating scale ,Headache disability Inventory and Cranio-cervical flexion test to determine the more effective intervention. |