| CTRI Number |
CTRI/2024/03/063995 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Mckenzie and Mulligan on Cervicogenic headache. |
|
Scientific Title of Study
|
Effectiveness of Mckenzie and Mulligan snags on 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 |
Trupti Raghunath Mule |
| Designation |
Physiotherapist |
| Affiliation |
Rajiv Gandhi University of Health and Science |
| Address |
City college of Physiotherapy,
Ground floor, Physiotherapy Out Patient Department Room No A to D, Mangalore, City Enclave, Shakthinagar, Mangalore.
Dakshina Kannada
KARNATAKA
575016
India |
| Phone |
9987520820 |
| Fax |
|
| Email |
truptimule93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amar Prakash |
| Designation |
Principal |
| Affiliation |
City college of Physiotherapy |
| Address |
City college of Physiotherapy,
Ground floor, Physiotherapy Out Patient Department Room No A to D, Mangalore, City Enclave, Shakthinagar, Mangalore.
Dakshina Kannada
KARNATAKA
575016
India |
| Phone |
8971455313 |
| Fax |
|
| Email |
amarprakash150@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Trupti Raghunath Mule |
| Designation |
Physiotherapist |
| Affiliation |
City college of Physiotherapy |
| Address |
City college of Physiotherapy, Ground floor, Physiotherapy Out Patient Department Room No A to D Mangalore, City Enclave, Shakthinagar, Mangalore.
Dakshina Kannada
KARNATAKA
575016
India |
| Phone |
9987520820 |
| Fax |
|
| Email |
truptimule93@gmail.com |
|
|
Source of Monetary or Material Support
|
| City college of Physiotherapy Mangalore, Ground Floor, Physiotherapy Out Patient Department Room A to D, City Enclave, Shaktinagar, Mangalore- 575016 |
|
|
Primary Sponsor
|
| Name |
Trupti Raghunath Mule |
| Address |
City college of Physiotherapy, City Enclave, Shakthinagar, Mangalore. 575016 |
| 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 |
| Dr Trupti Raghunath Mule |
City College Physiotherapy |
Out patient department,
Ground Floor, Room A- D, City Enclave, Shakthinagar, Mangalore. 575016
Dakshina Kannada
KARNATAKA |
9987520820
truptimule93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| City College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
McKenzie retraction principle |
McKenzie retraction principle followed with Force Progression (Patient overpressure, Clinical overpressure, Mobilization) along with posture correction, Retraction with extension.
With the respective exercise advice at home everyday with 10 rep every 1-2 hour in a day total of 8-10 times. Total no of sessions will be depending upon the patients recovery. But minimum of 12 sessions will be incorporated and further follow up will be done. |
| Comparator Agent |
Mulligan SNAG |
Mulligan C1- C2 ROTATION SNAG along with deep neck flexors strengthening. Total no of sessions will be depending upon the patients recovery. But minimum of 12 sessions will be incorporated and further follow up will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Pain localized to neck and occipital region, pain is aggravated by neck movements or sustained neck postures, positive flexion rotation test, weakness in neck muscles |
|
| ExclusionCriteria |
| Details |
Headache not of cervical origin, Headache with autonomic involvement, congenital conditions of cervical spine, contraindication to manipulative therapy, inability to tolerate flexion rotation test |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache Disability Index (HDI) |
Headache disability index (HDI) time points are in 1st day of the treatment, on 5th day of the treatment, on 12th day of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability index (NDI) |
NDI time points are on 1st day of the treatment , on 5th day of the treatment, on 12th day of the treatment |
| Flexion rotation test (FRT) |
FRT time points are in 1st day of the treatment, on 5th day of the treatment, on 12th day of the treatment |
| Numeric Pain Rating System (NPRS) |
NPRS time points are in 1st day of the treatment, on 5th day of the treatment, on 12th day of the treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/04/2024 |
| 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 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
|
This study is a Randomized clinical trial where effectiveness of McKenzie and Mulligan SNAGS will be compared for the patients suffering from Cervicogenic Headache (CGH). Total of 40 patients will be randomized in two experimental groups by fulfilling the inclusion criteria. Group A with 20 patients in which McKenzie treatment will be incorporated and group B with 20 patients in which Mulligan treatment will be given. Objective of the study is to determine which treatment procedure is more effective in CGH. The results of both groups will be compared in relation with Headache Disability Index (HDI), Neck Disability Index (NDI), Flexion Rotation Test (FRT), Numeric Pain Rating Scale (NPRS) on 1st, 5th, and 12th day. |