| CTRI Number |
CTRI/2024/04/065196 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Transverse Glide on the second cervical spine for the treatment of Cervicogenic Headache. |
|
Scientific Title of Study
|
The Effect of C2 Transverse glide for the Treatment of Cervicogenic headache: A randomized control 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 |
Dr Umasankar Mohanty |
| Designation |
Chief Consultant Physiotherapist |
| Affiliation |
MTFI Manual Therapy Clinic |
| Address |
Director, Research division, Room No.02, Manual Therapy and Pain Clinic,301-302, 3rd floor, Janvi plaza Commercial complex, Bunts hostel Road, Mangalore-575003, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9448104132 |
| Fax |
|
| Email |
prof.mohanty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adithya Vinay |
| Designation |
Clinical Physiotherapist |
| Affiliation |
MTFI Manual Therapy Clinic |
| Address |
Convener,Research division, Room No:03, Manual Therapy and Pain Clinic, 301-302, 3rd floor, Janvi Plaza Commercial complex, Bunts hostel Road, Mangalore-575003, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
6282471289 |
| Fax |
|
| Email |
adithya.vinay1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adithya Vinay |
| Designation |
Clinical Physiotherapist |
| Affiliation |
MTFI Manual Therapy Clinic |
| Address |
Covener, Research Division, Room No:03, Manual Therapy and Pain Clinic, 301-302, 3rd Floor , Janvi Plaza Commercial Complex, Bunts Hostel Road, Mangalore-575003, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
6282471289 |
| Fax |
|
| Email |
adithya.vinay1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manual Therapy Foundation of India |
|
|
Primary Sponsor
|
| Name |
Manual Therapy Foundation of India |
| Address |
301-302, 3rd floor, Janvi Plaza, Bunts Hostel Road, Mangalore |
| Type of Sponsor |
Research institution |
|
|
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 Umasankar Mohanty |
MTFI Manual Therapy Clinic |
MTFI Clinical research division, Room number 03,Manual Therapy and Pain Clinic,301-302, 3rd floor, Janvi plaza, Bunts hostel Road, Mangalore-575003, Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9448104132
prof.mohanty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Manual Therapy Foundation Of India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention given in control group |
No intervention given in control group. Subject is asked to come after 10 days. |
| Intervention |
Transverse Glide |
The subject is in prone lying position. The Fingers of both hands are interlocked and forehead is kept under palm (so the cervical lordosis is obliterated and joint is in loose pack position) Clinician/ Therapist places with the pulp of the thumb lateral to spinous process of C2 and the the therapist/clinician applies grade 2 and grade 3 transverse glide mobilization with pulp of the thumb of the dominant hand with reinforcement from pulp of thumb of non dominant hand. The technique is applied for 10 times. The treatment will be given for 10 days. The
primary outcome measures includes Headache disability index, Neck disability index, Visual analogue scale, Numeric pain rating scale from the intervals of baseline, 1 week, 2 weeks, 4 weeks and 2 months. secondary outcome measure includes Cervical ROM, Deep cervical flexors, Motor performance, Head ache duration intervals of Baseline, 1 week,2 weeks, 4 weeks and 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral headache without side-shift.
Minimum 1-year history of headache with a minimum mean frequency of 1 per week.
Pain intensity greater than 6 on a 10 cm Visual Analogue Scale at the time of presentation.
Hypomobility of the upper cervical spin C0-C3 on manual examination.
Reproduction of headache on palpation of the upper cervical spine C0-C3
|
|
| ExclusionCriteria |
| Details |
Headache not of cervical origin
Headache with autonomic involvement, dizziness, or visual disturbance
Congenital conditions of the cervical spine
Contraindications to manipulative therapy
Inability to tolerate the flexion-rotation test |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache disability index
Neck disability index
Visual Analogue Scale
Numerical Pain Rating Scale |
Baseline
1 week
2 weeks
4 weeks
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cervical ROM.
Deep cervical flexors motor performance.
Headache duration.
|
Baseline
1 week
2 weeks
4 weeks
2 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/04/2024 |
| 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 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
|
Cervicogenic headache (CEH) is a unilateral headache localized in the neck or occipital region, projecting to the frontal and temporal regions. In this study 84 subjects will be included in the age group from 18 to 60 years. The primary outcome measures are Headache Disability Index, Neck Disability Index, Visual Analogue Scale and Numerical Pain Rating Scale . The secondary outcome measures are cervical ROM, deep cervical flexors motor performance and headache duration. The outcome measures will be analyzed in the time periods of 1 week, 2 weeks, 4 weeks and 2 months. The data will be collected and analyzed further.
Directional Hypothesis: 1)Transverse glide to C2 is a safe and effective method for reducing duration and frequency of cervicogenic headache. 2)Transverse glide to C2 is effective in increasing cervical ROM. 3)Transverse glide to C2 has a significant effect in boosting the motor performance of the deep cervical flexors.
Null Hypothesis: 1)Transverse glide to C2 is not effective in reducing duration and frequency of cervicogenic headache. 2)Transverse glide to C2 is not effective in increasing Cervical ROM. 3)Transverse glide to C2 does not contribute to boosting the motor performance of the deep cervical flexors. |