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CTRI Number  CTRI/2025/12/098767 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
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   Effects of using Direct Current on Head with exercises in Neck Pain 
Scientific Title of Study   Effect of Transcranial Direct Current Stimulation on Pain, Disability and Muscle Endurance in Chronic Non-Specific Neck Pain Subjects: A Randomized Sham 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  Neha R Kulkarni 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy, Pune 
Address  Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pune

Pune
MAHARASHTRA
411026
India 
Phone  7767947939  
Fax    
Email  nrk.688@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neha R Kulkarni 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy, Pune 
Address  Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pune

Pune
MAHARASHTRA
411026
India 
Phone  7767947939  
Fax    
Email  nrk.688@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neha R Kulkarni 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy, Pune 
Address  Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pune

Pune
MAHARASHTRA
411026
India 
Phone  7767947939  
Fax    
Email  nrk.688@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Physiotherapy, Pune 
 
Primary Sponsor  
Name  Dr. D. Y. Patil College of Physiotherapy, Pune 
Address  Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pune 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neha R Kulkarni  Dr. D. Y. Patil College of Physiotherapy  Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 7767947939

nrk.688@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr. D Y Patil College of Physiotherapy, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Sham transcranial Direct Current Stimulation plus Neck stabilization exercises 
Intervention  Experimental Group  Transcranial Direct Current Stimulation Plus Neck Stabilization Exercises 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Between the ages of 20-45 years
2. Both males and females
3. Chronic or recurrent neck pain lasting for at least 3 months without a clear underlying cause.
4. Grade I and II level neck pain according to the “Neck Pain Task Force Classification”
5. Pain intensity: 2 to 7 on NRS
 
 
ExclusionCriteria 
Details  1. Infectious and non-infectious inflammatory or destructive tissue changes of the cervical spine or in the areas of brain
2. Recent or previous surgeries in and around cervical and skull area
3. Current participation in a structured exercises program
4. Neurological symptoms of the upper extremities during screening tests or during treatment
5. Signs and symptoms of progressive pain exaggeration
6. Past or present History of epilepsy, stroke or psychiatric illnesses
7. Neurological conditions
8. Metal Implants in and around the skull or cervical area
9. Presence of severe or frequent headache, chronic skin disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Numerical Rating Scale
2. Neck Disability Index
3. Neck Muscles Endurance Tests
4. Forward Head Posture  		 Pre- 0 Day to Post- 4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Cervical Range of Motion
Global Perceived Effect 		 Pre- 0 Day to Post- 4 Weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   30/12/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The study is aimed at finding the effectiveness of a developing modality named Transcranial Direct Current Stimulation (tDCS) in Chronic Non Specific Neck Pain patients. This treatment will be given with an addition of neck exercises and compared to a control group where sham tDCS with exercises will be administered. A total of 20 sessions will be given for both the groups and Pre-Post data on Pain intensity, neck disability, cervical muscle endurance will be taken.  
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