Immersive Virtual Reality for Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203772
• Other study ID #: 5150437
• Status: Completed
• Phase: N/A
• Start date: August 14, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an engaging virtual mirror therapy experience. The investigators are interested in studying the use of virtual reality as an alternative treatment option for these conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb

Exclusion Criteria:

• Cognitive impairment leading to inability to make own medical decisions

• Complete inability to utilize leg or arm muscles that are needed for motion controller tracking

• History of seizures within the last year

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Neuralgia
• Neuropathic Pain
• Neuropathy
• Phantom Limb
• Phantom Limb Pain
• Reflex Sympathetic Dystrophy

Intervention

Other:
• Immersive Virtual Reality
Participants will engage in virtual visualization therapy in an immersive virtual reality environment

Locations

Country	Name	City	State
United States	Loma Linda University Health, East Campus Outpatient Rehabilitation Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Virtual Reality Environment Use Questionnaire	Using a questionnaire, feedback over participant self-reported tolerance of the virtual reality environment, participant likelihood of recommending this therapy to others with similar conditions, reported sense of presence in presented scenario(s), comfort of virtual reality devices, impact on self-reported functional ability outside of clinic, and overall impression of virtual reality therapy will be recorded.	Immediately following final virtual reality session
Primary	Pain Relief with Virtual Reality Therapy: Wong-Baker Scale	Change in Wong-Baker Faces pain scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.	Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Primary	Pain Relief with Virtual Reality Therapy: Visual Analog Scale	Change in Visual Analog Pain Scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.	Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Primary	Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale	Change in Short-Form McGill Pain Questionnaire will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.	Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions