| CTRI Number |
CTRI/2024/10/075459 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| 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
|
Effect of Mulligan mobilisation and Mechanical Traction in cervicogenic headache |
|
Scientific Title of Study
|
Comparative study between the effect of Mulligan Mobilisation(SNAG)with cervical isometrics exercises and mechanical traction with cervical isometrics exercises in 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 |
Tanvi Kumawat |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology Jaipur |
| Address |
Physiotherapy Ortho Lab ,department of Physiotherapy ,Mahatma Gandhi Physiotherapy College,RIICO Institutional area, sitapura, tonk road Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7014158411 |
| Fax |
|
| Email |
tanvi1994@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan Tiwari |
| Designation |
Dean and Principal |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology Jaipur |
| Address |
Dean and Principal Office Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area,sitapura,tonk road Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8290964159 |
| Fax |
|
| Email |
principal.physiotherapy@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhusudan Tiwari |
| Designation |
Dean & Principal |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology Jaipur |
| Address |
Dean and Principal office, Mahatma Gandhi Physiotherapy College ,Mahatma Gandhi University of Medical Sciences and Technology,RIICO institutional area, Sitapura, tonk road,Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8290964159 |
| Fax |
|
| Email |
principal.physiotherapy@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura , Tonk Road , Jaipur, Rajasthan (India) 302022 |
|
|
Primary Sponsor
|
| Name |
Tanvi Kumawat |
| Address |
Plot no. 25 Marg A5 Kumawat Colony Khatipura Road ,Jhotwara, Jaipur, Rajasthan,India 302012 |
| 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 Madhusudan Tiwari |
Mahatma Gandhi Hospital |
Room no. 14 Physiotherapy OPD , Basement
Jaipur
RAJASTHAN |
8290964159
principal.physiotherapy@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital , MGUMST,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G442||Tension-type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mechanical traction with isometrics |
1.Traction will be given with the patient in supine with neck in extension position the legs supported comfortably on a padded stool. 2.Intermittent cervical traction will be given with pulling force equals to one tenth of the body weight
3.The active treatment period will be 6 weeks and outcomes will be evaluated in the immediately post intervention week 7 |
| Intervention |
Mulligan’s SNAG mobilisation with isometrics |
1.SNAG technique will be performed with the patient sitting upright in a chair. 2.The physiotherapist will stabilize the occiput with the index, middle, and ring fingers of one hand while placing the little finger on the C2 spinous process.
3. After placing the hands in this way, the head forearm stabilized by the support and gently push the spinosus process ventrally with the other hand.
4.With this maneuver, C2 slides forward under C1, and therefore C1 moves forward relative to the skull.
5.The active treatment period will be 6 weeks and outcomes will be evaluated in the immediately post intervention week 7 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral or side-dominant headache without side shift
Headache with neck stiffness and/or pain Headache for the past 3 months at least once per week
Positive flexion-rotation test and restriction greater than 10degrees
|
|
| ExclusionCriteria |
| Details |
Headache not of cervical origin
Physiotherapy or chiropractic treatment in the past 3 months.
Headache with autonomic involvement, dizziness, or visual disturbance
Congenital conditions of the cervical spine
Contraindication to manipulative therapy
Involvement in litigation or compensation
Inability to tolerate the flexion-rotation test
|
|
|
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
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck disability index
Visual Analogue Scale
Goniometer |
6weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck disability index
Visual Analogue Scale
Goniometer |
0 day and 3rd week |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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="0"
Months="6"
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 will be a comparative study . Subjects
those will meet the inclusion criteria will be
randomly allocated to two groups:
Group-A & Group-B Prior to participation in this study Informed
consent of subjects will be taken and diagnostic criteria will be checked:To
assist in the diagnosis of cervicogenic headache , Hall and Robinson have
suggested flexion-rotation test (FRT), as described by Dvorak et al. This
passive examination procedure involves fully flexing the cervical spine so that
vertebral movement is theoretically constrained to C1- C2, then assessing
cervical rotation range of motion in this position. Normal range of movement is
44° . The FRT will be performed with the subject supine on a physiotherapy treatment
plinth. The cervical spine will be fully flexed by the examiner and the head
will be passively rotated to the left and right. Range will be determined by
either the onset of pain or firm resistance . Pretreatment and immediate
posttreatment values for rotation on the FRT will be recorded3. Group-A Mulligan’s SNAG mobilisation with isometrics
(n=20)
SNAG technique will
be performed with the patient sitting upright in a chair. The physiotherapist
will stabilize the occiput with the index, middle, and ring fingers of one hand while placing the little finger on the C2 spinous
process. After placing the hands in this way, the head forearm stabilized by
the support and gently push the spinosus process ventrally with the other hand.
With this maneuver, C2 slides forward under C1, and therefore C1 moves forward
relative to the skull2 .
Group –B Mechanical traction with isometrics (n=20)
Traction will be given with the patient in supine
with neck in extension position the legs
supported comfortably on a padded stool. Intermittent cervical traction will be
given with pulling force equals to one tenth of the body weight
The active treatment period will be 6 weeks and
outcomes will be evaluated in the immediately postintervention (week 7) |