| CTRI Number |
CTRI/2021/09/036990 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Immersive virtual reality device - OCULUS QUEST 2] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Double blinded Randomized control study
Immersive virtual reality to reduce neuropathic pain in spinal cord injury persons |
|
Scientific Title of Study
|
Immersive virtual reality to reduce neuropathic pain in persons with Spinal cord injury: A double blind Randomized controlled trial |
| Trial Acronym |
VR-NEUPASCI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMSON SELVARAJ J |
| Designation |
Post graduate resident |
| Affiliation |
Christian Medical College |
| Address |
Room no: 13,
Department of Physical Medicine and Rehabilitation,
Christian Medical College,
Vellore,
Tamil nadu, India
Vellore
TAMIL NADU
632004
India |
| Phone |
9677187156 |
| Fax |
|
| Email |
zamy619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Henry Prakash |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Room no:9
Department of Physical Medicine and Rehabilitation,
Christian Medical college and Hospital,
Vellore- 632004
Tamil Nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
9789249812 |
| Fax |
|
| Email |
henry.cmcv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAMSON SELVARAJ J |
| Designation |
Post graduate resident |
| Affiliation |
Christian Medical College |
| Address |
Room no: 13,
Department of Physical Medicine and Rehabilitation,
Christian Medical College,
Vellore,
Tamil nadu, India
Vellore
TAMIL NADU
632004
India |
| Phone |
9677187156 |
| Fax |
|
| Email |
zamy619@gmail.com |
|
|
Source of Monetary or Material Support
|
| Secretary,
Institutional Review Board,
Chrisitan Medical College,
Vellore,
Tamil nadu,
India - 632002 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Secretary,
Institutional Review Board,
Christian Medical College,
Vellore,
Tamil Nadu,
India - 632002 |
| Type of Sponsor |
Private 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 Samson Selvaraj |
Christian Medical College |
Room No: 213,
Department of Physical Medicine and Rehabilitation,
Occupation therapy Division,
Rehabilitation Institute,
Christian Medical College,
Bagayam post,
Vellore,
Tamil Nadu - 632002
Vellore
TAMIL NADU |
9677187156
zamy619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
The participants in the control group will receive sham intervention instead of immersive virtual reality illusion environment for two 15 minutes sessions per day, 5 days of the week for a period of two weeks. Control group will be watching 2D animated films with the same set up. This would be aimed to control for the effect of simply receiving visual input. |
| Intervention |
INTERVENTION GROUP |
The participants in the intervention group in addition to standard care will receive immersive virtual reality illusion environment exposure for two 15 minutes sessions per day, 5 days of the week for a period of two weeks. During virtual reality, the participants will be made to sit comfortably on their wheelchairs with their safety harness and wheelchair locked in place. Then, the participants will be exposed to an immersive virtual reality environment where he/she will be virtually walking and cycling.
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Persons with SCI between 16 and 60 years of age, both genders and who are able to follow therapy instructions and capable of participating in daily therapy sessions.
Persons with SCI thoracic level lesion with Complete (ASIA – A) and sensory incomplete (ASIA - B) and motor incomplete (ASIA - C) lesions based on “The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)â€
Presence of neuropathic pain with LANSS score of 12 or more
Persons with ongoing stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial
|
|
| ExclusionCriteria |
| Details |
SCI persons with associated traumatic brain injury and comorbidities such as neurological and psychiatric disorders, visual impairment and who are not willing to give consent to participate in the study will be excluded. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neuropathic pain
|
At baseline
At two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depersonalization |
At baseline
At two weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/10/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 the spinal cord that leads to varying degrees of motor and/or sensory deficits and paralysis. Patients with spinal cord injury (SCI) frequently experience neuropathic pain in their subacute and chronic phase, with rates reported between 26% and 96%. This pain has an impact on function, quality of life, and mood that can exceed the other consequences of SCI such as physical impairment or psychological distress. Thus, SCI associated neuropathic pain should be managed as early as possible. Currently, Virtual reality, a technology-based intervention is being tried to manage chronic painful conditions.
After complete SCI, lack of all modalities of sensations below the level of lesion may lead to plastic changes in the sensory-motor cortex causing depersonalization (Abnormal body schema). Hence, we would like to study the presence of depersonalization and the effect of virtual reality on depersonalization.
In this study, the persons with SCI will be randomized into virtual reality (intervention) group and sham (control) group. The patients will receive either virtual reality or 2D animated movies and cartoons for 15 minutes per session, 2 sessions per day, 5 days in a week for a period of 2 weeks.
The Leeds Assessment of Neuropathic symptoms and signs (LANSS) scale and Cambridge Depersonalization Scale (CDS) will be used to quantify the neuropathic pain and depersonalization respectively, before and after the intervention period. Participants will be randomized by block method; allocation will be managed by a person external to the study by block randomization. Intervention group will be given virtual reality (VR) exposure for a duration of about 15 minutes and the control group will be shown a normal video for a duration of 15 minutes in each session. Two sessions per day. 5 days in a week for a period of 2 weeks. After two weeks, its effect on neuropathic pain is assessed using LANSS and depersonalization by CDS.
Effectiveness of virtual reality in neuropathic pain and its relationship with depersonalization will be analysed.
|