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CTRI Number  CTRI/2025/03/081851 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Virtual Reality and Pregabalin]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effect of Virtual Reality Rehabilitation Training and Pregabalin on Neuropathic pain over only Pregabalin in Traumatic Spinal Cord Injury Patients. 
Scientific Title of Study   Comparing the effect of Virtual Reality and Pregabalin on Neuropathic pain over only Pregabalin in Traumatic Spinal Cord Injury: 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  Dr Raj Kumar Yadav 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Faculty Room, 6th Floor, Department of PMR, Administrative Building, AIIMS Rishikesh, Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  8800264547  
Fax    
Email  raj.pmr@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raj Kumar Yadav 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Faculty Room, 6th Floor, Department of PMR, Administrative Building, AIIMS Rishikesh, Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  8800264547  
Fax    
Email  raj.pmr@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Hrishikesh Das 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Flat Number 204, Aadinath Residency, Aambag Street Number 2, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8670677563  
Fax    
Email  rickyrock036@gmail.com  
 
Source of Monetary or Material Support  
Department of PMR,AIIMS Rishikesh, Uttarakhand, India PIN:249203 
 
Primary Sponsor  
Name  Department of PMRAIIMS Rishikesh 
Address  Shivaji Naga Rishikesh Uttarakhand India PIN:249203 
Type of Sponsor  Government medical college 
 
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 
Dr Hrishikesh Das  AIIMS Rishikesh  Department of PMR Gait Analysis Division Room Number : 36, Gait and VR Lab, 4th Floor, Academic Building
Dehradun
UTTARANCHAL 
8670677563

rickyrock036@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G958||Other specified diseases of spinalcord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pregabalin   Pregabalin 75 mg once daily dosing to be given for neuropathic pain. Total Duration: 14 Days 
Intervention  Virtual Reality Training along with Pregabalin 75 mg OD dosage. Session: 30 Min Total Duration: 14 Days  Virtual Reality (VR) is a simulated construction of 3D environment using computer and artificial intelligence technology. Current VR systems include head-mounted devices with 3D-glasses, sensory input devices, noise cancellation headphones, body-tracking sensors and input devices like joysticks,[13] forming a multisystem device giving realistic multisensory experience. Technological improvements in VR, offer an alternative solution of several medical conditions and show promise in improving symptoms like pain reduction in short and long term. Session: 30 Min Total Duration: 14 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Complaints of neuropathic Pain
Diagnosed as Traumatic Spinal Cord Injury
Duration of injury more than 3 months 
 
ExclusionCriteria 
Details  1. Patient with known pregabalin hypersensitivity or with product specific ingredient hypersensitivity.
2. Pregnant and Breastfeeding women.
3. Significant visual or hearing impairment.
4. Severe headache that may impact VR training.
5. Uncontrolled Hypertension Systolic more than 200 mmHg, Diastolic more than 110 mmHg.
6. Uncontrolled Seizures.
7. Any psychiatric illness leading to inability to follow commands completely.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Brief Pain Inventory Scale (Short Form)  Day 0(Baseline), Day 15, Day 45 
 
Secondary Outcome  
Outcome  TimePoints 
Spinal Cord Independence Measure (SCIM)  Day 0, Day 15, Day 45 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/02/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Spinal cord injury (SCI) is an injury to spinal cord leading to motor and/or sensory deficits [1] and by definition excludes isolated injuries to nerve roots [2], may cause function loss, autonomic disturbances and increased morbidity & mortality.

Pain is commonly reported in SCI patients, mainly neuropathic pain [3] Hypothesised that neuropathic pain below and at level of spinal injury is due to exaggerated neuronal responses to stimuli below normal thresholds.[4] The hyperexcitability is due to altered ion receptors and channels, decreased endogenous inhibitory neurons in dorsal horn.[5] Another theory includes changes at supraspinal level like neuroplasticity with primary somatosensory cortex reorganisation. [6-8] Neuropathic pain is also associated with functional changes in thalamus with animal studies showing abnormal patterns of firing in it. [9].

International Association for Study of Pain Neuropathic Pain Special Interest Group [10], recommend pregabalin as first-line treatment for neuropathic pain (NeP), alongside other drugs like tricyclic antidepressants, serotonin–noradrenaline reuptake inhibitors, and gabapentin [11]. The dose for treatment of NeP starts at 150 mg divided into two (BID) or three (TID) doses per day, increasing to 300 mg/day depending on therapeutic indication, increasing to a maximum of 600 mg/day.[12]

In clinical practice however patient may develop early side effects even with 150 mg/day, likely leading to therapy discontinuation so recommendation for low dose, and slowly titrating to therapeutic dose (termed ‘low and slow’ approach) is given [13] with starting dose as low as 25 mg/day (in elderly or frail patients) or 50 mg/day. 

Virtual Reality (VR) is a simulated construction of 3D environment using computer and artificial intelligence technology. Current VR systems include head-mounted devices with 3D-glasses, sensory input devices, noise cancellation headphones, body-tracking sensors and input devices like joysticks,[13] forming a multisystem device giving realistic multisensory experience. Technological improvements in VR, offer an alternative solution of several medical conditions and show promise in improving symptoms like pain reduction in short and long term.[13]

The processes underlying effect of VR on pain have been broadly divided into two main types: distraction and neuroplasticity [14] and are believed to contribute to the analgesic effect of VR.

Distraction refers to the short-term diversion of attention away from pain towards an alternative stimulus. VR may act directly and indirectly to reduce pain by “hijacking” of attention, emotion and memory as well as visual, auditory and touch senses.[14] Neuroplasticity contributes to the effects of VR by long-term structural changes in neurons by involving in interactive real-time simulations of scenes or activities, leading to neuroplastic alterations in sensory and motor brain regions.[15]

In clinical practice however patients on pregabalin for neuropathic pain may develop early side effects even with recommended dose of 150 mg/day given over two doses a day. The adverse effects can range from somnolence, oedema, visual disturbances, ataxia, vertigo and euphoria and can likely lead to reason for therapy discontinuation. VR can provide an alternative to current pharmacologic treatment and can be used in addition to pregabalin for neuropathic pain to minimise its side effects, allowing starting dose to be as low as 25 mg/day (in elderly or frail patients) or 50 mg/day, and slowly titrating to therapeutic dose (termed ‘low and slow’ approach) [13]

 
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