| CTRI Number |
CTRI/2023/07/054745 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2023 |
| 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
|
Effectiveness of 2 Different Mobilization Technique in Cervicogenic Headache- A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of Two Different Mobilization Technique in 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 |
Divya Singh |
| Designation |
Masters Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology, Hisar |
| Address |
Department of physiotherapy(OPD), GJUS&T,Hisar HARYANA
Hisar
HARYANA
125001
India |
| Phone |
9718052689 |
| Fax |
|
| Email |
divyasingh97180@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology, Hisar, HARYANA |
| Address |
Department of physiotherapy,Guru Jambheshwar University of Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet_physio@gjust.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology, Hisar, HARYANA |
| Address |
Department of physiotherapy,Guru Jambheshwar University of Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
8708711667 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar university of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Divya Singh |
| Address |
Department of Physiotherapy Guru Jambheshwar university of Science and Technology Hisar |
| 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 |
| Divya Singh |
OPD, Health Centre, GJUS&T, Hisar |
Department of Physiotherapy, Neurophysiotherapy, Room no. 4,5, GJUS&T
Hisar
HARYANA |
9718052689
divyasingh97180@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Postural Rehabilitation |
All stretching and strengthening are done |
| Intervention |
Pressure Maintained Suboccipital
Inhibition Technique(PMSIT) |
The pressure-maintained suboccipital inhibition technique
(PMSIT), which is applied for 5 minutes, was used in the PSMIT group for 18 sessions and pressure is applied over the sub-occipital region |
| Intervention |
Suboccipital Translatory Dorsal Glide Mobilization(TDGM) |
TDGM Group participants for 18 sessions
(three sessions per week on alternate days). The technique was used for 5 minutes per session
in cycles of 15-second dorsal pushes followed by 3-5-second rests |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Cervicogenic Headache
Minimum of 3 weeks
Reduced ROM
Unilateral Headache |
|
| ExclusionCriteria |
| Details |
Patients who had headache other than primary headaches (i.e., migraine, TTH)
Nerve root compression
Any upper extremity dermatome with diminished or absent pinprick sensation
Stenosis of the cervical spine |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale (NPRS)
Headache impact test (HIT-6) |
Pain by NPRS
Headache intensity
Headache frequency |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index(NDI) |
neck range of motion |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
13/07/2023 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 the most common secondary type of headache condition affecting general population. Management of this condition put the global burden. Most of the headache leads to increase in its intensity and frequency resulting in causing pain the cervical and sub-occipital region and reducing the neck range of motion. As the cases of cervicogenic headache are on the rise globally. Literature shows various techniques for the treatment of CGH. Also, these techniques have been compared to find out their benefit on various parameters. But due to the paucity of literature on the comparison of mobilization techniques, the present study was initiated to directly compare the effects of different mobilization techniques on parameters for treating CGH. This study include pressure maintained sub-occipital inhibition and translatory dorsal glide mobilization to find the effect of these in treating cervicogenic headache. |