| CTRI Number |
CTRI/2025/08/092778 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of brain and spinal direct current stimulation along with exercise in cervicogenic headache |
|
Scientific Title of Study
|
Effects of trans-cranial and trans-spinal direct current stimulation along with exercise on headache intensity, disability, pain pressure threshold and range of motion in patients with 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 |
Meghna Wadhwa |
| Designation |
Sr. Assistant Professor |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
Physiotherapy Department School of Allied Health Sciences Sardar Bhagwan Singh University Balawala Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9456710565 |
| Fax |
|
| Email |
sethimeghna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meghna Wadhwa |
| Designation |
Sr. Assistant Professor |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
Physiotherapy Department School of Allied Health Sciences Sardar Bhagwan Singh University Balawala Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9456710565 |
| Fax |
|
| Email |
sethimeghna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. R. Arunmozhi |
| Designation |
Professor |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
Physiotherapy Department School of Allied Health Sciences Sardar Bhagwan Singh University Balawala Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895617031 |
| Fax |
|
| Email |
rmozhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Bhagwan Singh University |
|
|
Primary Sponsor
|
| Name |
Meghna Wadhwa |
| Address |
Physiotherapy Department School of Allied Health Sciences Sardar Bhagwan Singh University Balawala Dehradun |
| 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 |
| Meghna Wadhwa |
Physiotherapy department Sardar Bhagwan Singh University |
Physiotherapy department Sardar Bhagwan Singh University Balawala Dehradun
Dehradun
UTTARANCHAL |
9456710565
sethimeghna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB-Sardar Bhagwan Singh University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Rehabilitation Programme for 5 consecutive days |
This programme will be perfomed at pain free level and will be progressed as patients improve |
| Intervention |
Tran-spinal Direct Current Stimulation |
For 5 consecutive days (2mA for 20 mins with a 30 sec fade in and fade out time.Cathode on somatosensory cortex and anode on T10 |
| Intervention |
Trans-Cranial Direct Current Stimulation |
5 Consecutive sessions(2mA for 20 mins with a 30 sec fade in and fade out time).Anode is placed at primary motor cortex and cathode at supraorbital area. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Cervicogenic headache with clinical or imaging evidence.
Temporal headache developed with onset of cervical disorder.
Reduced cervical range of motion.
Patient must have NPRS score of ≥4/10 and HDI score of ≥40.
|
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they exhibit other primary headaches
If suffering from bilateral headaches
If they show any red flags
Have nerve root compression
Have spinal stenosis
Have CNS involvement
If they have undergone neck surgery
Pregnancy
Any skin condition |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache Disability Index(HDI) |
Recording will be done on 1st & 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale(NPRS) |
Recording will be done on 1st & 5th day |
| Pain Pressure Algometer(PPA) |
Recording will be done on 1st &5th day |
| Headache impact test(hit-6) |
Recordings will be done on 1st & 5th day |
| Cervical range of motion(CROM) |
Recordings will be done on 1st & 5th day |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="2"
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
|
Cervicogenic Headache with prevalence of 38% is chronic and recurrent headache with unilateral pain radiating from neck to temporal area. Its likely cause is convergence of afference of the trigeminal and upper three cervical spinal nerves onto the second order neurons in the trigeminocervical nucleus in the upper cervical spinal cord. Most of the researchers provide suggestions for a central and peripheral approach to resolve this headache. Thus the aim of our study is to determine the effectiveness of two novel interventions tDCS and tsDCS along with conventonal rehabilitation in treatment of cervicogenic headache. |