| 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
|
|
|
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
|
|
|
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] |