Immersive virtual reality to reduce neuropathic pain in persons with Spinal cord injury: A double blind Randomized controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Christian Medical College
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Neuropathic pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 16.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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)†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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Neuropathic pain
Time Frame: At baseline | At two weeks
Secondary Outcomes
- Depersonalization(At baseline)