Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Neuropathic Pain Symptom Inventory (NPSI)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
Detailed Description
When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.
Investigators
David Putrino
Director of Rehabilitation Innovation
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Spinal cord injury survivors (chronic only)
- •Presence of neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord
- •A pain intensity of at least 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
- •Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial
Exclusion Criteria
- •Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
- •Head injuries causing cognitive or visual impairment
- •Severe vertigo
Outcomes
Primary Outcomes
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Up to 10 Weeks
Neuropathic Pain Symptom Inventory (NPSI): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPSI is 0-100, higher scores indicate more severity.
Secondary Outcomes
- Spinal Cord Independence Measure (SCIM III)(Up to 10 Weeks)
- Immersive Tendencies Questionnaire (ITQ)(Up to 10 Weeks)
- User Experience Score (UES)(14 Days)
- Numerical Pain Rating Scale (NPRS)(16 Days)
- Beck Depression Inventory (BDI)(Up to 10 Weeks)
- Patient's Global Impression of Change (PGIC)(Up to 10 Weeks)
- UQO- Presence Questionnaire (UPO-PQ)(16 Days)
- Neuropathic Pain Scale (NPS)(Up to 10 Weeks)