Immersive Virtual Reality for Neuropathic Pain

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Neuropathy; Phantom Limb Pain; Complex Regional Pain Syndromes; Neuropathic Pain	Other: Immersive Virtual Reality	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality
Actual Study Start Date :	January 2016
Estimated Primary Completion Date :	January 2019
Estimated Study Completion Date :	January 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Limb neuropathic conditions; Includes phantom limb pain, complex regional pain syndrome	Other: Immersive Virtual Reality; Participants will engage in virtual visualization therapy in an immersive virtual reality environment

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Feasibility of Virtual Reality Environment Use Questionnaire [ Time Frame: Immediately following final virtual reality session ]
   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.
2. Pain Relief with Virtual Reality Therapy: Wong-Baker Scale [ Time Frame: 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 ]
   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.
3. Pain Relief with Virtual Reality Therapy: Visual Analog Scale [ Time Frame: 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 ]
   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.
4. Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale [ Time Frame: 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 ]
   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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Brian Chau, MD	909-558-6202

Locations

United States, California
Loma Linda University Health, East Campus Outpatient Rehabilitation Center	Recruiting
Loma Linda, California, United States, 92354
Contact: Brian Chau, MD 909-558-6202 bchau@llu.edu

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator:	Brian Chau, MD	Loma Linda Univeristy

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Brian Chau, Physician Instructor, Principle Investigator, Department of Physical Medicine and Rehabilitation, Loma Linda University
ClinicalTrials.gov Identifier:	NCT03203772 History of Changes
Other Study ID Numbers:	5150437
First Posted:	June 29, 2017
Last Update Posted:	July 14, 2017
Last Verified:	July 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Phantom Limb; Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Pain; Neurologic Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases	Neuromuscular Diseases; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Autonomic Nervous System Diseases