| CTRI Number |
CTRI/2024/04/065453 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| 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
|
Comparing Neck Muscle Release to Hands-On Therapy for cervicogenic headache |
|
Scientific Title of Study
|
Effect of Mulligan technique with suboccipital release versus IASTM on Cervicogenic headache |
| Trial Acronym |
MT-SR vs. IASTM on CH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chitra Barotia |
| Designation |
Student |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, School of Allied Medical sciences
Lovely professional university
Jalandhar Delhi G.T.Road,Phagwara.
Hoshiarpur
PUNJAB
144411
India |
| Phone |
8107275402 |
| Fax |
|
| Email |
chitrabarotia99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Kapoor |
| Designation |
Associate professor |
| Affiliation |
Lovely professional university |
| Address |
Department of physiotherapy, School of Allied Medical sciences
Lovely professional university
Jalandhar Delhi G.T.Road,Phagwara.
Hoshiarpur
PUNJAB
144411
India |
| Phone |
9872400711 |
| Fax |
|
| Email |
gauravkapoor00711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Kapoor |
| Designation |
Associate professor |
| Affiliation |
Lovely professional university |
| Address |
Department of physiotherapy, School of Allied Medical sciences
Lovely professional university
Jalandhar Delhi G.T.Road,Phagwara.
Hoshiarpur
PUNJAB
144411
India |
| Phone |
9872400711 |
| Fax |
|
| Email |
gauravkapoor00711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University
Department of Physiotherapy, Allied Medical sciences, room no.105 |
|
|
Primary Sponsor
|
| Name |
Chitra Barotia |
| Address |
Lovely Professional University
Department of Physiotherapy, Allied Medical sciences. |
| 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 Chitra Barotia |
Department of Physiotherapy |
Room no.105, Department of Physiotherapy, school of Allied Medical sciences,
Lovely Professional University.
Jalandhar, Delhi G.T. Road.
Jalandhar
PUNJAB |
8107275402
chitrabarotia99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cervicogenic Headache |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Therapy |
Neck stretching will be given for sternocleidomastoid, upper trapezius, suboccipital, scalene muscles (3 repetitions with 30 second hold). Post treatment neck isometric exercises will be advised to the patients 10 repetition each, strengthning exercises for neck flexors and extensor muscles. treatment will be given for 3 times in a week for 4 weeks total 12 sessions will be given |
| Comparator Agent |
Mulligan mobilizationIASTM (Instrument assisted soft tissue mobilization) |
Mulligan-
In this technique, the patient sits on a chair while the therapist applies pressure to the C2-C4 vertebrae using the SNAG technique. The patient flexes their neck while pressure is maintained, followed by overpressure for deeper joint glide. This is repeated for 3 sets with 6 repetitions each, with NAGs used if needed. treatment will be given for 3 times in a week for 4 weeks total 12 sessions will be given.
IASTM (Instrument Assisted Soft Tissue Release-
IASTM involves applying gentle pressure to affected tissues using specialized tools. Various techniques are used to release tension and improve mobility in the neck, suboccipital, and upper back areas contributing to the headache. treatment will be given for 3 times in a week for 4 weeks total 12 sessions will be given. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-Unilateral cervicogenic headache along with motor and/or sensory symptoms
-Patient with tingling, numbness, burning sensation, pinpricking sensation.
-Voluntary participation |
|
| ExclusionCriteria |
| Details |
-Musculoskeletal disease, Cardiovascular and respiratory disease
-Patients who are undergoing treatment for neck pain with other means of
physiotherapy or medication at the time of the study
-Cervical spine fracture, surgery, or other pathological condition
-Central Nervous System (CNS) involvement
-Medical red flags (tumor, RA, OA, osteoporosis, cancer etc.) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric Pain Rating Scale (NPRS)
3. Neck Disability Index (NDI) |
1. Numeric Pain Rating Scale (NPRS)- 12 times
3. Neck Disability Index (NDI)-4 times
4 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Range of Motion-12 times 4 weeks |
1. Range of Motion- 12 times 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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 |
|
Date of First Enrollment (India)
|
18/04/2024 |
| 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="0"
Months="2"
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 (CGH) is a chronic, unilateral, and sometime bilateral pain of cervical region that arises from the atlanto occipital region and upper cervical joint to the neck region. Cervicogenic headache one of commonest form of headache or we can say it is a secondary common type of headache, occurs by disorder of the neck region structures.This RCT investigates cervicogenic headache (CGH), a common chronic pain condition originating from the cervical region. It affects 15-20% of chronic headache sufferers, with higher rates in females. Treatment involves a multidisciplinary approach, with a preference for conservative methods like physiotherapy, manual therapy (MT), and exercise. MT techniques such as Mulligan mobilization, SNAG, and traction are effective in improving joint mobility and reducing pain. Addressing musculoskeletal dysfunctions and releasing fascial restrictions are essential components of CGH management. |