| CTRI Number |
CTRI/2024/02/062923 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Cervical stabilization Exercises and Cervical Headache SNAG with Sensorimotor training On Pain
And Functional Disability Among Cervicogenic Headache Patients |
|
Scientific Title of Study
|
Effect of Cervical Stabilization Exercises Versus Cervical
Headache SNAG Following Sensorimotor Retraining On Pain
And Functional Disability Among Cervicogenic Headache Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrushti Sameer Dixit |
| Designation |
Intern |
| Affiliation |
Dr. Ulhas Patil college of physiotherapy |
| Address |
Khirdi Shivar, Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
India
Khirdi shivar, Tal and district jalgaon
Jalgaon
Maharashtra
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
7218290692 |
| Fax |
|
| Email |
dixitshrushti444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradnya Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Dr Ulhas Patil college of physiotherapy |
| Address |
physiotherapy OPD 207 Khirdi Shivar, Tal And Dist Jalgaon
Physiotherapy opd 207, Khirdi shivar, Tal and District jalgaon
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9284034348 |
| Fax |
|
| Email |
ppradz1816@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradnya Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Dr Ulhas Patil college of physiotherapy |
| Address |
physiotherapy OPD 207 khirdi shivar, Jalagoan
Physiotherapy OPD 207 khidi shivar, jalgaon
Jalgaon
MAHARASHTRA
4250309
India |
| Phone |
9284034348 |
| Fax |
|
| Email |
ppradz1816@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ulhas Patil college of physiotherapy ,
khirdi shivar NH 06 ,Tal a d district JALGAON pin code 425309 |
|
|
Primary Sponsor
|
| Name |
Shrushti Dixit |
| Address |
Datta nagar, nashirabad Jalgaon |
| Type of Sponsor |
Private medical college |
|
|
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 Pradnya Mahajan |
DR ULHAS PATIL MEDICAL COLLEGE & HOSPITAL, JALGAON |
Khirdi shivar, Physiotherapy OPD 207,Tal and dist Jalgaon
Maharashtra
Jalgaon
MAHARASHTRA |
9284034348
ppradz1816@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr. Ulhas Patil college of physiotherapy |
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 |
| Intervention |
Cervical stabilization exercises using PBU unit, sensorimotor retraining, Cervical headache SNAG |
Cervical stabilization exercises includes Deep neck flexors (DNF) strengthening using Pressure biofeedback (PBU) unit.
3 days a week on alternate days for 5 weeks
Total 15 sessions of each exercise
Sensorimotor retraining exercises includes oculomotor and postural stability exercises
Cervical headache SNAG is Mulligans mobilization for C2 level cervical vertebrae
3 sessions per week on alternate days for 5 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral headache, headache with neck stiffness and pain, positive flexion-rotation test, restriction of extension and rotation range of motion in cervical spine, precipitation of headache with neck movement and sustained head positioning, intermittent headache of varying duration and pain level at the rate of one headache per week for greater than two months, headache with moderate intensity |
|
| ExclusionCriteria |
| Details |
Chiropractic treatment in past 3 months, headache with autonomic involvement and visual disturbance, congenital condition of cervical spine, cervical radiculopathy, tension type headache and migraine, fracture or previous surgery on vertebral column, spinal stenosis and disc prolapse and TMJ dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale (NPRS), Neck disability index (NDI), Headache disability index (HDI) |
5 weeks , 3 days alternate in each week, total 15 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="6" |
|
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
|
Ethical clearance will be obtained from institutional ethical committee and principal of Dr. Ulhas Patil college of physiotherapy, jalgaon. A written informed consent form will be obtained from subject who are willing to participate. Subjects will be screened according to inclusion and exclusion criteria. The procedure, aim and objective will be explained to willing participants.Then participants screened with flexion-rotation test and to be confirmed with Cervicogenic headache. selected total 40 participants will be divided into two groups using simple random sampling or lottery method. All participants pre treatment evaluation NPRS, NDI, HDI score will be noted. Group’A’ will receive Cervical stabilization Exercises using pressure biofeedback unit along with sensorimotor retraining exercises which include oculomotor and postural stability exercises. And Group’B’ receive cervical headache SNAG along with sensorimotor retraining exercises. Both groups receive intervention for 5 weeks on alternate days. Post treatment response of all participants of NPRS, NDI, HDI will be noted |