| CTRI Number |
CTRI/2025/06/089529 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of transcranial direct current stimulation combined with exercises for reducing pain and improving posture in people with chronic non specific neck pain. |
|
Scientific Title of Study
|
Effect of transcranial direct current stimulation with exercises on pain, function and forward head posture in chronic non specific neck pain: A randomised sham controlled trail. |
| 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 Neha Kulkarni |
| Designation |
Associate professor |
| Affiliation |
Dr. D.Y Patil college of physiotherapy Pimpri , Pune |
| Address |
Dr. D.Y Patil Vidyapeeth , Pimpri,Pune
Dr. D.Y Patil college of physiotherapy Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Kulkarni |
| Designation |
Associate professor |
| Affiliation |
Dr. D.Y Patil college of physiotherapy Pimpri , Pune |
| Address |
Dr. D.Y Patil Vidyapeeth , Pimpri,Pune
Dr. D.Y Patil college of physiotherapy Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vrinda Agnihotri |
| Designation |
Post graduate |
| Affiliation |
Dr. Dy Patil college of physiotherapy, Pimpri pine |
| Address |
Dr. Dy Patil college of physiotherapy,Pimpri, Pune
Dr. D. Y Patil vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9811085795 |
| Fax |
|
| Email |
vrindaagnihotri1805@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Neha Kulkarni |
| Address |
Dr. D.Y Patil college of Physiotherapy, Pimpri, Pune,411018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neha Kulkarni |
Dr. D.Y Patil college of Physiotherapy, Pimpri Pune |
Pimpri Pune -411018
Pune
MAHARASHTRA |
7767947939
neha.kulkarni@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y.Patil College of Physiotherapy,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic non specific neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
randomized sham controlled trial |
4 weeks intervention with tDCS and exercises. Outcome measures will be compared and taken at baseline and 4 weeks of intervention. |
| Comparator Agent |
sham tdcs with exercises |
4 week intervention with tDCS and exercises. Outcome measures will be compared and taken at baseline and 4 weeks of intervention. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
patients suffering from neck pain for 12 weeks or more and have no specific cause for pain |
|
| ExclusionCriteria |
| Details |
Pregnant ladies
Recent fractures of trauma to neck or upper back.
Recent surgery
Severe heart disease, recent heart attack or any issue which restricts the participant from participation in the intervention.
Cervicogenic headache
Cervical Radiculopathy.
Epilepsy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Visual analogue scale
2)Copenhagen neck functional disability scale
3)Kinovea software |
at baseline and after 4 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
18/07/2025 |
| 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="0"
Months="8"
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
|
Thirty to fifty percent of people suffer from chronic non-specific neck pain, which is frequently brought on by aspects of modern living including persistent poor posture, especially forward head posture. Disability, a lower quality of life, and trouble with day-to-day functioning are the results of this disorder. Despite being widely used, traditional treatments—such as different strengthening and therapy modalities—frequently have variable results. Through the central pain gate mechanism, transcranial direct current stimulation (tDCS), a new physiotherapy technique, may lessen pain by promoting neuroplasticity and modifying pain perception.There is little and conflicting data about the effectiveness of tDCS for general neck pain, despite early research suggesting it may help with ailments like fibromyalgia, cervicogenic headaches, and low back pain. Therefore, more study is required to examine how tDCS and exercise therapy work together to provide long-lasting pain relief and functional improvement for those with persistent, non-specific neck pain. 60 participants with non specific neck pain will be selected randomly and will be divided into 2 groups(interventional group, sham group). Treatment will be given for 4 weeks,5 days a weeks and outcome measures will be compared pre and post the intervention. |