| CTRI Number |
CTRI/2025/08/092578 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| 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
|
Effect of Physiotherapy treatment on Stress in individuals with cervicogenic headache |
|
Scientific Title of Study
|
Efficacy of cranial mobilization and
temporomandibular mobilization with mulligan manual therapy for reduction in salivary cortisol in individual with cervicogenic headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HIMANSHU MATHUR |
| Designation |
Associate Professor |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
301, RR Heights, C-10, Jetram Nagar Opposite Radha Nikunj-I, Muhana Mandi Road
Jaipur
RAJASTHAN
302029
India |
| Phone |
9649784338 |
| Fax |
|
| Email |
drhimanshumathur5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HIMANSHU MATHUR |
| Designation |
Associate Professor |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
301, RR Heights, C-10, Jetram Nagar Opposite Radha Nikunj-I, Muhana Mandi Road
RAJASTHAN
302029
India |
| Phone |
9649784338 |
| Fax |
|
| Email |
drhimanshumathur5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HIMANSHU MATHUR |
| Designation |
Associate Professor |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
301, RR Heights, C-10, Jetram Nagar Opposite Radha Nikunj-I, Muhana Mandi Road
RAJASTHAN
302029
India |
| Phone |
9649784338 |
| Fax |
|
| Email |
drhimanshumathur5@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Himanshu Mathur |
| Address |
301, RR HEIGHTS, C-10, JETRAM NAGAR, MUHANA MANDI ROAD, JAIPUR- 302029 |
| Type of Sponsor |
Other [None] |
|
|
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 Himanshu Mathur |
JAIPUR NATIONAL UNIVERSITY INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
OPD 1
Department of Physiotherapy JNU Hospital Ghati Karolan
near New RTO
Jagatpura
Jaipur
RAJASTHAN |
9649784338
drhimanshumathur5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe (IEC) JNUIMSRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cervicogenic Headache |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cranial Mobilisation |
Frontal Lift Technique
With the participants in supine with the head supported
to avoid any extension, the therapist sits behind the head
of the participant. The therapist holds the frontal bone from both the sides of the frontal bone with the finger pads. Gently therapist drags the fingers superiorly and hold with mild force for 3 repetitions of 30 seconds
each. It is performed 2 times per week for 6 weeks |
| Comparator Agent |
Mulligan Sustained Natural Apophyseal Glide |
The procedure of Mulligan SNAG (Sustained Natural Apophyseal Glide) involves a specific technique used in manual therapy to increase joint movement and provide pain relief. It is commonly used in the treatment of cervicogenic headache and other musculoskeletal conditions. |
| Comparator Agent |
Temporomandibular Joint Mobilisation |
With the patient in sitting, the therapist sits behind the
patient and palpates the mandibular condyle of the side
of headache. The mandibular condyle can be palpated
behind the tragus of the ear. A gentle force is applied
posterior to the mandibular condyle in anterior direction. A rhythmic mobilisation glide is performed for 10 times in 3 repetitions. The mobilisation is performed for 2 times per week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with cervicogenic headache fulfilling the diagnostic criteria according to
International Classification of Headache Disorder (ICHD-III)
Having a forward head posture with the value of craniovertebral angle less than
50.58 degree
Level of salivary cortisol should be greater than 1.55 µg/dL
Individuals with active mouth opening less than 30mm measured with a Vernier
caliper
The value for Headache Disability Inventory (HDI) should be more than 10 |
|
| ExclusionCriteria |
| Details |
Any history of head and neck trauma
Associated conditions like vertigo, dizziness
Presence of diseases like Cushing’s disease and Addison’s disease which could alter
the levels of salivary cortisol
Pittsburgh Sleep Quality Index (PSQI) score less than 5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Salivary Cortisol |
Day 0
Day 21
Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Craniovertebral Angle
Active Mouth Opening
Headache Disability Inventory
Headache Impact Test |
Day 0
Day 21
Day 90 |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
20/08/2025 |
| 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="1"
Months="0"
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
|
The study specifically examines the relationship between cervical spine dysfunction stress biomarkers (salivary cortisol) and TMJ issues in cervicogenic headache patients addressing a comprehensive view of the condition rather than treating symptoms in isolation. The randomized controlled trial design with 168 participants and multiple assessment timepoints (Day 0, 21, and 90) provides robust evidence. The use of objective measures like Kinovea software for posture analysis and salivary cortisol testing adds scientific rigor. |