| CTRI Number |
CTRI/2024/08/072087 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| 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
|
To compare the effects of cranial base release and neck stabalization exercises on cervicogenic headache |
|
Scientific Title of Study
|
Comparing the effects of Cranial Base Release and Cervical Stabilization exercises on Cervicogenic 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 |
Sanjna Mirupa |
| Designation |
Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
08628997982 |
| Fax |
|
| Email |
sanjnamirupa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7018518005 |
| Fax |
|
| Email |
drgeetanjalikaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7018518005 |
| Fax |
|
| Email |
drgeetanjalikaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kuamrhatti, Solan, 173229, India |
|
|
Primary Sponsor
|
| Name |
Sanjna Mirupa |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| 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 |
| Sanjna Mirupa |
Maharishi Markandeshwar University |
Maharishi Markandeshwar University, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH |
08628997982
sanjnamirupa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MM Medical College and Hospital Solan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cervical stabalization exercises |
Initially the pre-assessment of the patient will be taken through NPRS, ROM, NDI and HDI then will be given moist heat pack. The patient will be in comfortable position (prone lying) and apply the hydrocollator pack on the neck region. Keep the heat pack for 15 minutes.
After the application of hydrocollator pack, TENS will be applied at an 80 Hz frequency and 10–30 mA intensity for 10 to15 minutes. Four surface electrodes measuring five by five centimetres each will be applied to the painful region of neck. TENS will be adjusted 2-3 times to give a tingling sensation to the patient.
following exercises will be taught to patient: Deep neck flexor strenghtening, cervical range of motion exercises, trapezius, levator and pectoral stretching. these exercises will be performed 10 times each set for 2 weeks.
|
| Intervention |
Cranial Base Release |
Patient must be in a supine position, before beginning the treatment, the patient might be made more comfortable by placing a pillow beneath their head.
The therapist will sit at the head of the bed and place both hands beneath the patients head in the occipital region once they are comfortable and positioned correctly. Next, the therapist should move their hands slightly caudad till they feel the muscle, which is located along the occipital ridge along the head. The therapist next applies upward finger flexion pressure to the suboccipital muscles, maintaining this posture for three to five minutes, or until a noticeable relaxation of muscle tension is achieved.
After a total of two weeks of treatment, the patient will have a post-assessment using the NPRS, ROM, NDI, and HDI.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 and 35 years
2. Both male and female are included
3. Patient fulfilling ICHD diagnostic criteria for CGH
4. Positive Cervical Flexion-rotation test
5. Pain localised to neck and occiput region projecting to forehead
6. Headache which responds to cervical treatment
7. Experiencing headache at least once per week for the last 6 months
|
|
| ExclusionCriteria |
| Details |
1. Acute trauma/injury to cervical or thoracic spine
2. Non cervicogenic headache (migraine, tension type headache)
3. Cervical radiculopathy
4. Presence of symptoms like vertigo, dizziness and visual impairments
5. Underlying pathology (tumours, infection)
6. Any cervical spine surgery
7. Physiotherapy treatment for headache in last 6 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
Neck disability index
headache disability index |
at baseline and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cervical range of motion |
at baseline and 14th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
10/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 (CGH) is a secondary
headache characterized by unilateral headache, and symptoms and signs of neck
involvement. It is often worsened by neck movement, sustained awkward head
position or external pressure over the upper cervical or occipital region on
the symptomatic side. Cervical headaches are estimated to affect approximately
2.5% of the adult population and account for 15- 20% of all chronic and
recurrent headaches. WHO (2016) states that adults between the ages of 20 and 50 are most
prone to experience headaches, which can be a symptom of a variety of
neurological diseases. CGH
is very common among people now a days, majority of them being females. There
are many studies which have shown effects of different therapeutic modalities
and exercise therapy on cervicogenic headache. CBR and CSE are known to be
effective approaches for cervicogenic headache but there is lack of literature
for comparative studies between the effects of CBR and CSE on CGH, leaving it
necessary to determine which approach is more beneficial so that it can be used
in clinical settings in conjunction with the standard physiotherapy protocol
for CGH. |