Immersive Virtual Reality for Neuropathic Pain

NCT03203772 | Completed

• 1 other identifier: 5150437
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathy; Phantom Limb Pain; Complex Regional Pain Syndromes; Neuropathic Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Limb neuropathic conditions

EXPERIMENTAL

Includes phantom limb pain, complex regional pain syndrome

Other: Immersive Virtual Reality

Interventions

Immersive Virtual Reality OTHER

Participants will engage in virtual visualization therapy in an immersive virtual reality environment

Limb neuropathic conditions

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health, East Campus Outpatient Rehabilitation Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Phantom Limb; Complex Regional Pain Syndromes; Neuralgia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Brian Chau, MD

  Loma Linda Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 29, 2017
• Study Start: August 14, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

US (1)