| CTRI Number |
CTRI/2026/01/101031 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of Transcranial Direct Current Stimulation and Dry Needling on Headache in College Students : A RCT |
|
Scientific Title of Study
|
Comparative Efficacy of Transcranial Direct Current Stimulation(tDCS) and Dry Needling on Headache Intensity, Frequency, Cervical Range of Motion, and Quality of Life in College Students diagnosed with Migraine and Cervicogenic Headache: A Randomized Controlled 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 |
GHAZALA KHAN |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Galgotias Unviersity, Greater Noida
Department of Physiotherapy, Galgotias University
South
DELHI
110025
India |
| Phone |
9560052847 |
| Fax |
|
| Email |
drghazalakhanpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamran Ali |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, Galgotias university
Plot No 2 Sector 17 A Yamuna Expressway Greater Noida Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9540686786 |
| Fax |
|
| Email |
drghazalakhanpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GHAZALA KHAN |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Department Of Physiotherapy, Galgotias University
Department Of Physiotherapy, Galgotias University
South
DELHI
110025
India |
| Phone |
9560052847 |
| Fax |
|
| Email |
drghazalakhanpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil.
information of Data Collection : Chandiwala Estate, Maa Anandmai Marg, Kalkaji, New Delhi-110019 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ghazala Khan |
Banarsidas Chandiwala Institute of Physiotherapy |
Department of Physiotherapy, Room 420,Banarsidas Chandiwala Institute of Physiotherapy.
South
DELHI |
9560052847
drghazalakhanpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MIGRAINE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Needling Group
Duration: 4 weeks (12 sessions in total) |
Participants in this group will receive dry needling therapy targeting muscles commonly associated with cervicogenic headache.
Muscles Targeted:
Upper Trapezius – implicated in cervical and shoulder tension
Suboccipitals – involved in head and neck posture
Dry needling will be performed by a certified physiotherapist using sterile, single-use filiform needles. Trigger points will be identified by palpation and clinical examination. A pistoning (in-and-out) technique will be used to elicit a local twitch response, indicating effective trigger point deactivation.
Dosage: 1–2 trigger point sites per muscle group, based on severity
Frequency: 3 sessions per week
Duration: 4 weeks (12 sessions in total)
|
| Comparator Agent |
NIL |
NIL |
| Intervention |
Transcranial Direct Current Stimulation (tDCS)
Total Duration: 4 weeks (12 sessions) |
Participants in this group will receive anodal tDCS targeting the left dorsolateral prefrontal cortex (DLPFC), with the cathode placed over the contralateral supraorbital area.
Device: CE-certified tDCS device for research use
Electrode Size: 5x7 cm sponge electrodes
Stimulation Parameters:
Intensity: 2 mA
Duration: 20 minutes per session
Frequency: 3 sessions/week
Total Duration: 4 weeks (12 sessions)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
migraine |
|
| ExclusionCriteria |
| Details |
Neurological or psychiatric disorders
History of head injury or epilepsy
Contraindications to tDCS or dry needling
On-going physiotherapy or pharmacological treatment for headache |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache Intensity: Visual Analog Scale (VAS), where participants will rate the average headache intensity over the past week on a 10 cm line ranging from "no pain" to "worst imaginable pain."
Headache Frequency: Documented as the total number of headache days experienced in the past month, regardless of duration or intensity maintaining through headache diary.
Cervical Range of Motion (ROM) Assessed using a cervical goniometer and flexion rotation test.
Quality of Life (QoL): Evaluated using the Headache Impact Test (HIT-6) and/or the Migraine-Specific Quality of Life Questionnaire (MSQOL) |
Base, 2 week, 4th week and 15 days post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep Index, Psychological stress and Anxiety and |
Base, 2 week, 4th week and 15 days post treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Comparative Efficacy of Transcranial Direct Current Stimulation and Dry Needling on Headache Intensity Frequency Cervical Range of Motion and Quality of Life in College Students diagnosed with Migraine and Cervicogenic Headache A Randomized Controlled Trial Dr.Kamran Ali Ghazala Khan Associate Professor 24SMAS3030002 Department of Physiotherapy Registration No Galgotias University Galgotias University SAHS Greater Noida, U.P Introduction Headaches are among the most common problems faced globally, significantly impacting the quality of life, productivity, and mental well-being, especially among college students Headache and cervicogenic headache (CGH) are frequently reported types with overlapping symptoms The Growing Burden of Headache Headache is a widespread problem affecting an estimated 1.16 billion people globally, making it one of the leading causes of disability worldwide According to recent epidemiological data, the global prevalence of headaches has increased by 58.15% from 732.56 million cases in 1990 to over a billion in 2021 During the same period, the incidence rate surged by 42.06%, while disability-adjusted life years rose by 58.27%, underscoring its growing impact on public health, productivity, and healthcare utilization The burden of headache exhibits notable disparities across age groups, sexes, and socioeconomic regions. Epidemiological data indicate a higher prevalence and greater disease burden of headache among women, characterized by increased attack frequency, duration, and disability. These disparities contribute to higher healthcare utilization, including specialist consultations and prescription medication use, potentially influenced by hormonal and neurological mechanisms Adolescents under 20 years old show the fastest increase in prevalence, suggesting a worrying trend in younger populations Geographically, East Asia and Latin America exhibit the most significant increases in headache cases, whereas Southeast Asia has shown a decline With predictive models suggesting a continued rise in headache prevalence until 2050, particularly among male individuals and adolescents, urgent action is required |