| CTRI Number |
CTRI/2025/08/092577 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Comparing Virtual Reality and Pain neuroscience Education and Regular Physiotherapy for long lasting neck pain without clear cause for pain |
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Scientific Title of Study
|
The short-term effects of virtual reality versus pain neuroscience education versus conventional physiotherapy on pain, kinesiophobia, catastrophizing, and disability in patients with non-specific chronic neck pain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya C V |
| Designation |
post graduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 Dharwad KARNATAKA 580009 India |
| Phone |
8197905683 |
| Fax |
|
| Email |
kavyacv73222@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kavya C V |
| Designation |
post graduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 Dharwad KARNATAKA 580009 India |
| Phone |
8197905683 |
| Fax |
|
| Email |
kavyacv73222@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sweta Kulkarni |
| Designation |
professor and PG Guide |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 Dharwad KARNATAKA 580009 India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical science and hospital, SDM college of physiotherapy, manjushree nagar, sattur, dharwad - 580009 india |
|
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Primary Sponsor
|
| Name |
Kavya C V |
| Address |
OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavya C V |
SDM college of physiotherapy |
OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 Dharwad KARNATAKA |
8197905683
kavyacv73222@gmail.com |
| Dr Sweta Kulkarni |
SDM college of physiotherapy |
OPD No 5, orthopedic physiotherapy department, SDM college of physiotherapy, SDM college of medical science and hospital,manjushree nagar sattur, dharwad 580009 Dharwad KARNATAKA |
9886276543
dr.shweta07@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Virtual reality and exercises |
Participants in the Virtual Reality (VR) group will undergo VR-based rehabilitation combined with therapeutic exercises. Each session will begin with an orientation to ensure safe and proper use of the VR device. Participants will engage in VR activities such as interactive games (e.g., roller coaster or racing games) designed to encourage neck movement in multiple directions. These activities will be performed in a seated position and controlled by head and neck movements (flexion, extension, lateral rotation). Each VR session will last for approximately 10–15 minutes, twice a week for 4 weeks. In addition, participants will be prescribed a home exercise program including chin tucks, cervical range of motion exercises, scapular retraction, and deep neck flexor activation to be performed daily. |
| Intervention |
Group B - Pain neuroscience education and exercises |
Participants in this group will receive education on neurobiology and neurophysiology of pain, emphasizing the concept that pain is not always a sign of tissue damage but a protective response by the nervous system. Education will be provided using pamphlets, metaphors, and examples from the book Explain Pain by Butler and Moseley. Graded Motor Imagery will be introduced, including left/right discrimination and explicit motor imagery tasks using the Recognise™ app. PNE sessions will be supplemented with a home exercise program (chin tucks, cervical ROM, scapular retraction, deep neck flexor activation) to be performed daily for 4 weeks. |
| Comparator Agent |
Group C - CONVENTIONAL PHYSIOTHERAPY |
Participants in this group will undergo traditional physiotherapy focusing on cervical mobility, strengthening, and postural correction exercises. Sessions will progress weekly from basic exercises (chin tucks, cervical ROM, scapular retraction) to advanced strengthening and functional tasks (isometric neck strengthening, scapular wall slides, resisted neck movements with elastic bands). Each session will last 45–60 minutes, twice a week for 4 weeks. A similar exercise program will be prescribed as a home program for daily practice. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having neck pain more than 12 weeks or 3months.
2) Age group of 18 to 65 years
3) VAS more than 3
4) TSK-17 score more than 17
5) PCS more than 30
6) NDI more than or equal to 15
|
|
| ExclusionCriteria |
| Details |
1) Severe cervical instability or recent trauma
2) Vertigo or vestibular disorders
3) Severe motion sickness
4) Active cervicogenic headache or migraines
5) Visual or speech or hearing impairments
6) Pregnancy.
7) Unwilling to participate voluntarily
8) Suspected cervical spinal pathology like-malignancies, Unhealed vertebral fractures, ankylosing spondylitis, Inflammatory arthritis.
9) Cervical radiculopathy
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1) VAS
2) Tampa scale of kinesiophobia 17
3) Pain catastrophizing scale
4) Pain pressure threshold – aesthsiometer
5) Neck disability index scale
|
1) VAS - baseline and 4th week
2) Tampa scale of kinesiophobia 17 - baseline and 4th week
3) Pain catastrophizing scale - baseline and 4th week
4) Pain pressure threshold – aesthsiometer - baseline and 4th week
5) Neck disability index scale - baseline and 4th week
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Range of motion |
Neck Range of motion - baseline and 4th week |
|
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Target Sample Size
|
Total Sample Size="81" Sample Size from India="81"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a randomized controlled trial investigates the short-term effects of three physiotherapy approaches Virtual Reality (VR), Pain Neuroscience Education (PNE), and conventional physiotherapy on individuals with non-specific chronic neck pain, focusing on outcomes like pain intensity, kinesiophobia, catastrophizing, and disability. Chronic neck pain is a growing health issue, especially in India, due to poor postural habits, prolonged digital device use, and sedentary lifestyles. Despite a surge in technological advancements like VR and increased interest in educational approaches such as PNE, most existing research is based in high-income nations and lacks contextual relevance to Indian populations. The study recognizes the importance of understanding psychological contributors to chronic pain, particularly fear of movement and catastrophic thinking, which are often neglected in conventional protocols. The trial includes 81 subjects aged 18–65 years, divided into three groups Group A (VR-based therapy + exercise), Group B (PNE + exercise), and Group C (conventional therapy). Pain will be measured using the Visual Analogue Scale (VAS) and Pain Pressure Threshold, kinesiophobia with the Tampa Scale (TSK-17), catastrophizing with the Pain Catastrophizing Scale (PCS), and disability with the Neck Disability Index (NDI). Each group follows a structured 4-week treatment plan, with outcome measures assessed at baseline and after completion. VR therapy aims to reduce pain through distraction and multisensory engagement. PNE seeks to shift the patient’s understanding of pain from a tissue-damage focus to a central nervous system perspective using metaphors and cognitive tools. Conventional therapy emphasizes structured exercise progression with heat application. Previous literature supports the benefits of all three interventions, yet comparative studies remain sparse. This research aims to fill that gap by providing India-specific evidence on efficacy and feasibility. If proven effective, VR and PNE may offer cost-effective, scalable alternatives for physiotherapy delivery, especially in underserved rural settings. Ethical clearance and informed consent will be obtained prior to enrollment. The findings are expected to aid clinicians in choosing effective, personalized interventions for managing chronic neck pain and may significantly improve the quality of life in affected individuals while reducing healthcare burden through innovative, accessible care models.
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